[ { "trial": "T004", "source": "library", "arms": { "Coadministration group (propofol + ketamine)": { "randomized": "20", "analysed": "19" }, "Propofol group (propofol alone)": { "randomized": "20", "analysed": "20" } }, "depression": [], "pain": [], "adverse_events": [ { "window": "intraoperative", "location": "Results, second paragraph", "values": { "Coadministration group (propofol + ketamine)": { "agitation": "0", "any_ae": "0" }, "Propofol group (propofol alone)": { "agitation": "1", "any_ae": "1" } } }, { "window": "emergence", "location": "Results, fourth paragraph (Propofol 'four'); abstract and Discussion (none with coadministration)", "values": { "Coadministration group (propofol + ketamine)": { "dissociation": "0" }, "Propofol group (propofol alone)": { "dissociation": "4" } } } ], "blinding_check": null, "enrollment": null, "registration": null, "note": "Randomized 20 per arm (Methods). Analysed: Propofol 20, Coadministration 19 in the abstract, Table 1 and Figure 1 (the missing Coadministration patient is not explained); the Figure 2 caption gives them the other way round (Propofol n = 19, Coadministration n = 20). Depression: the 'depressed/elated' mood VAS (before surgery and 15 min after arrival in the PACU) is shown only in Figure 2 (median, 25th-75th percentiles) with no printed values, so no entries; the text says postoperative mood scores were higher with coadministration for all six mood states. Pain: no values at day 1 or 2; post-discharge pain at rest and during activity and hydrocodone use on the first postoperative day are given only as P values, and Table 3 gives time (days) to normalization, median (quartiles): Propofol pain at rest 5 (4, 5), during activity 4 (4, 4), hydrocodone 4 (4, 4); Coadministration 3 (2, 4) for each. Pain VAS on arrival to Phase 2 recovery (day 0, not extracted): Propofol 20 [2.0-20.0], Coadministration 0 [0.0-0.0], median [quartiles]; intraoperative fentanyl 1.1 ± 0.5 µg/kg in both (Table 1); PACU morphine not quantified. AEs: the only intraoperative adverse event was 'transient restlessness' in the Propofol group ('there was only one event'), coded agitation and any_ae; the Coadministration zeros follow from that statement rather than a printed 0. Mild perceptual changes (VAS scores ≤20) in surroundings, time, colors and sounds in 'four' Propofol patients (printed as a word), seen in recovery and absent 30 min after surgery, coded dissociation (derealization-type perceptual change; the source gives this specific count, not a combined psychiatric or psychotomimetic one, so not psychiatric_any), window emergence (it could also be read as early postoperative). The abstract ('without perceptual changes after surgery') and Discussion ('No psychotomimetic or perceptual symptoms were observed after surgery') give the Coadministration group's 0, stated in words. No changes in the suspicion, weird feeling or thought-process VAS in either group (scores, not counts). No enrollment period or registration given.", "decided_by": "third reader" }, { "trial": "T005", "source": "library", "arms": { "Group A (propofol, fentanyl, ketamine)": { "randomized": "35", "analysed": "35" }, "Group B (propofol, fentanyl)": { "randomized": "35", "analysed": "35" } }, "depression": [ { "measure": "Hamilton Depression Rating (HDR) score, 21 items", "day": -1, "form": "mean_sd", "location": "Results, third paragraph; abstract", "values": { "Group A (propofol, fentanyl, ketamine)": { "mean": "12.7", "sd": "5.4" }, "Group B (propofol, fentanyl)": { "mean": "12.3", "sd": "6.0" } } }, { "measure": "Hamilton Depression Rating (HDR) score, 21 items", "day": 1, "form": "mean_sd", "location": "Results, third paragraph; abstract", "values": { "Group A (propofol, fentanyl, ketamine)": { "mean": "9.9", "sd": "4.1" }, "Group B (propofol, fentanyl)": { "mean": "14.4", "sd": "3.8" } } }, { "measure": "Hamilton Depression Rating (HDR) score, 21 items", "day": 1, "form": "count", "definition": "HDR score up more than 5 points after surgery (a rise from the preoperative score, measured 2 days before surgery): a count of patients whose scores worsened, not of participants with depression (all had major depression); the source says only 'after surgery' (HDR was measured on days 1 and 3), and day 1 is the reading that fits its paragraph", "location": "Results, third paragraph", "values": { "Group A (propofol, fentanyl, ketamine)": { "events": "0", "n": "35" }, "Group B (propofol, fentanyl)": { "events": "8", "n": "35" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Results, last paragraph", "values": { "Group A (propofol, fentanyl, ketamine)": { "psychiatric_any": "5" }, "Group B (propofol, fentanyl)": { "psychiatric_any": "8" } } } ], "blinding_check": null, "enrollment": null, "registration": null, "note": "Group C (25 non-depressed controls, not randomized) left out. 35 per arm randomized and analysed (Methods, Table 1, outcome denominators 'of 35'); no per-time n is printed for the HDR means. Baseline HDR was measured 2 days before surgery (day -1). HDR means are from the Results text (also the abstract); Figure 1 (box plots) has no printed values, and day 3 has none (text: no significant difference between A and B). Count entry: 'Eight (23%) of 35 patients in Group B were up more than 5 points in HDR score after surgery, but there were no patients who were up more than 5 points in HDR score after surgery in Group A'; the time is not stated, so day 1 is a reading (the paragraph goes on to the day 1 means, the only time the arms differed), and the count could refer to day 3 or to either day; Group A's 0 is stated in words, Group B's 8 is printed as 'Eight', and Group A's n of 35 is the group's size, the sentence giving a denominator only for Group B. Table 2 gives HDR item scores (mean ± SD) 2 days before and the day after surgery (e.g., depressed mood 2.2 ± 1.2 vs 2.0 ± 1.0 before, 0.8 ± 0.8 vs 2.1 ± 1.0 after, A vs B; the text cites them as Table 1); items, not the listed total, so not extracted. Pain: VAS for A and B is printed only at 8 h (26.6 ± 8.7 vs 34.3 ± 12.0) and 16 h (24.9 ± 8.2 vs 31.1 ± 8.8) in the abstract, outside the 18-30 h window; the 24 h and later values for A and B are only in Figure 2 (only Group C's are printed). AEs: postoperative confusion by CAM (checked at least daily to day 7), 5 (14%) vs 8 (23%), coded psychiatric_any: it is the source's only psychiatric count, which the Methods analyse as 'psychosis emergence or confusion' and the Discussion treats as confusion 'such as hallucinations' and as emergence reactions; no excitement is described and it is not limited to emergence, so not agitation. Not coded: ventricular ectopic rhythm 1 vs 2; hypotension at induction 2 vs 2. No enrollment dates or registration given.", "decided_by": "third reader" }, { "trial": "T006", "source": "library", "arms": { "Placebo group": { "randomized": null, "analysed": "15" }, "Single S(+)-ketamine group": { "randomized": null, "analysed": "15" }, "Repeated S(+)-ketamine group": { "randomized": null, "analysed": "15" } }, "depression": [ { "measure": "Mood adjective choice after awakening (incl. 'depressed/euphoric', 'happy/sad')", "day": 0, "form": "count", "definition": "chose the adjective 'depressed' (Depressed/euphoric pair) for current mood after awakening", "location": "Table 2", "values": { "Placebo group": { "events": "0", "n": "15" }, "Single S(+)-ketamine group": { "events": "0", "n": "15" }, "Repeated S(+)-ketamine group": { "events": "0", "n": "15" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "Placebo group": { "psychiatric_any": "0" }, "Single S(+)-ketamine group": { "psychiatric_any": "0" }, "Repeated S(+)-ketamine group": { "psychiatric_any": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": null, "note": "Randomized per arm not printed: 52 enrolled; 2 withdrawn with arm not stated (failed epidural catheter; Bromage score >2 for more than 2 postoperative hours), 2 placebo patients discontinued, 3 single S(+)-ketamine patients excluded; 15 per group analysed (Table 1; abstract: 45 patients). Depression: Table 2 gives, per group, the number of patients choosing each adjective of six pairs after awakening; the entry counts 'depressed' from the Depressed/euphoric pair (printed 0/0, 0/0, 0/8 for placebo, single, repeated). Other pairs (placebo, single, repeated): Happy/sad 0/0, 0/0, 8/0 (no one chose 'sad'); Tense/relaxed 7/5, 4/8, 2/3; Agitated/calm 7/5, 4/8, 2/11; Afraid/brave 0/3, 0/3, 0/2; Alert/drowsy 10/0, 3/0, 0/0. Table 2 prints no n; 15 per group is from Table 1. Pain: VAS after awakening and at 3, 6, and 24 h is only in Figure 1 (box plots), patients needing additional analgesics only in Figure 2 (bars), and cumulative diclofenac and dextropropoxyphene at 24 h only in Figure 3, with no values printed. Adverse events: Table 2's 'Side effects attributable to ketamine' are 0, 0, 0 noted by patient and 0, 0, 0 noted by anesthesiologist (patients were asked at each postoperative evaluation about psychological effects, hallucinations, or dreams; text: no psychotomimetic side effects), coded psychiatric_any; Table 2 also gives hypotension 2, 0, 1 and nausea/vomiting 5, 4, 3 (not codebook categories).", "decided_by": "both coders" }, { "trial": "T009", "source": "library", "arms": { "Ketamine": { "randomized": "26", "analysed": "26" }, "Placebo (0.9% saline)": { "randomized": "26", "analysed": "26" } }, "depression": [ { "measure": "Geriatric Depression Scale 15-item", "day": -1, "form": "median_iqr", "location": "Table 3", "values": { "Ketamine": { "median": "3", "q1": "0", "q3": "4", "n": "26" }, "Placebo (0.9% saline)": { "median": "2", "q1": "0", "q3": "3", "n": "26" } } }, { "measure": "Geriatric Depression Scale 15-item", "day": 7, "form": "median_iqr", "location": "Table 3", "values": { "Ketamine": { "median": "2", "q1": "1", "q3": "3", "n": "26" }, "Placebo (0.9% saline)": { "median": "2", "q1": "1", "q3": "2", "n": "26" } } } ], "pain": [ { "measure": "Morphine consumption (mg)", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Ketamine": { "median": "15", "q1": "8", "q3": "22", "n": "26" }, "Placebo (0.9% saline)": { "median": "15", "q1": "8", "q3": "24", "n": "26" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2007-02", "end": "2008-03" }, "registration": null, "note": "GDS-15 (Table 3) is median (interquartile range), n = 26 per column. The 1-week test was 1 week after surgery or at discharge, whichever came first (coded day 7). Table 3's cells come through as PDF text blocks; I read them in the header's column order (placebo, ketamine, nonsurgical control at baseline, then the same at 1 week), which fits the Discussion (ketamine scores stable, nonsurgical controls improving). The design lists no pain measure; Table 2's morphine consumption on postoperative day 1 (mg, median (IQR)) is coded at day 1 under the source's name; day-of-surgery morphine (placebo 20 (10–24), ketamine 15 (10–20)) is day 0 and left out. No psychotomimetic adverse events reported. The nonsurgical control group (n = 26, not randomized) is left out.", "decided_by": "both coders" }, { "trial": "T011", "source": "library", "arms": { "K group": { "randomized": "60", "analysed": "60" }, "C group (0.9% saline)": { "randomized": "60", "analysed": "60" } }, "depression": [ { "measure": "PHQ-9", "day": -1, "form": "mean_sd", "location": "Table 2", "values": { "K group": { "mean": "4.02", "sd": "0.13" }, "C group (0.9% saline)": { "mean": "3.63", "sd": "0.14" } } }, { "measure": "PHQ-9", "day": 1, "form": "mean_sd", "location": "Table 2", "values": { "K group": { "mean": "2.68", "sd": "0.73" }, "C group (0.9% saline)": { "mean": "3.37", "sd": "0.91" } } }, { "measure": "PHQ-9", "day": 5, "form": "mean_sd", "location": "Table 2", "values": { "K group": { "mean": "2.28", "sd": "0.61" }, "C group (0.9% saline)": { "mean": "2.92", "sd": "0.63" } } }, { "measure": "PHQ-9", "day": -1, "form": "count", "definition": "PHQ-9 ≥ 5 (the source's 'depressed mood')", "location": "Discussion, second paragraph (Table 3: 5–10 row 23 K and 22 C, >10 row 1 K and 0 C)", "values": { "K group": { "events": "24", "n": "60" }, "C group (0.9% saline)": { "events": "22", "n": "60" } } }, { "measure": "PHQ-9", "day": 1, "form": "count", "definition": "PHQ-9 ≥ 5 (the source's 'depressed mood')", "location": "Table 3, 5–10 row (>10 row 0.00 in both groups); Discussion, third paragraph (≥5: 7 K, 17 C)", "values": { "K group": { "events": "7", "n": "60" }, "C group (0.9% saline)": { "events": "17", "n": "60" } } }, { "measure": "PHQ-9", "day": 5, "form": "count", "definition": "PHQ-9 ≥ 5 (the source's 'depressed mood')", "location": "Table 3, 5–10 row (>10 row 0.00 in both groups)", "values": { "K group": { "events": "6", "n": "60" }, "C group (0.9% saline)": { "events": "11", "n": "60" } } } ], "pain": [ { "measure": "VAS score", "day": 1, "form": "mean_sd", "location": "Table 1", "values": { "K group": { "mean": "2.17", "sd": "0.24", "n": "60" }, "C group (0.9% saline)": { "mean": "3.75", "sd": "0.42", "n": "60" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2014-03", "end": "2014-09" }, "registration": { "number": "ChicTR-OCC-14004280", "date": null }, "note": "Table 2 prints PHQ-9 as 'mean + SD' with a plus sign (Methods: data are mean ± SD); its rows are C then K, as the per-group F values in the text show (C F = 2.17, K F = 14.67). The printed dispersions look too small to be SDs (0.13 and 0.14 before surgery, while Table 3 has scores from 0-4 to >10), so they may be SEs or misprints; similar small values appear in Table 1 (e.g., age 41.40 ± 0.16; day 5 VAS 1.88 ± 0.01). The preoperative assessment was 1 day before surgery (day -1). Table 2 prints no n (60 per group, Table 1; Table 3's categories total 60 per arm at each time). Both forms are given for PHQ-9 at each time. Count entries: the source calls PHQ-9 ≥ 5 a depressed mood; Table 3 gives categories 0–4, 5–10 and >10, its percentages being shares of each row, not of each arm. The baseline count is printed in the Discussion (24 K, 22 C with PHQ-9 ≥ 5); days 1 and 5 are Table 3's 5–10 row, its >10 row being 0.00 in both groups (day 1 matches the Discussion: 7 in K, 17 in C). Pain: VAS day 1 from Table 1 (scale range not stated); the text's t value for day 1 VAS (t1 = −2.051, the same as PHQ-9's) differs from Table 1's (−6.048); day 5 VAS (1.12 ± 0.87 vs 1.88 ± 0.01) not extracted. No psychotomimetic adverse events reported; Table 1 gives nausea (day 1: 12 vs 13; day 5: 0 vs 0) and insomnia (day 1: 10 vs 9; day 5: 8 vs 8), K vs C. Enrollment from Methods ('between March 2014 and September 2014'). The registration number is printed 'ChicTR-OCC-14004280' beside ethics approval Ky2012044, with no date.", "decided_by": "third reader" }, { "trial": "T012", "source": "registry", "arms": { "Ketamine": { "randomized": "22", "analysed": "20" }, "Placebo": { "randomized": "23", "analysed": "20" } }, "depression": [ { "measure": "Beck's Depression Inventory", "day": 3, "form": "median_iqr", "location": "Posted results, secondary outcome 'Beck's Depression Inventory' (time frame: Post-op Day 3)", "values": { "Ketamine": { "median": "8", "q1": "5", "q3": "16", "n": "20" }, "Placebo": { "median": "9", "q1": "8", "q3": "11", "n": "20" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "values": { "Ketamine": { "any_ae": "0" }, "Placebo": { "any_ae": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT02424591", "date": null }, "note": "Randomized is the participant flow's STARTED (Ketamine 22, Placebo 23); analysed is COMPLETED (20 and 20), the number analysed for every outcome. Adverse events: the registry reports serious 0/20 and other 0/20 in each arm, reviewed from intraoperative through post-op day 3, coded as any_ae 0 with window overall; no individual events are listed. The only pain measure, the McGill Short Form (median, IQR: Ketamine 11 (4.5 to 18), Placebo 10.5 (8 to 17)), was assessed on post-op day 3 only, outside the day 1 and day 2 windows, so it is not coded. The registry text gives no enrollment dates or registration date.", "decided_by": "both coders" }, { "trial": "T013", "source": "registry", "arms": { "Ketamine Group": { "randomized": "6", "analysed": "0" }, "No ketamine group": { "randomized": "6", "analysed": "0" } }, "depression": [], "pain": [], "adverse_events": [ { "window": "overall", "location": "Adverse events", "values": { "Ketamine Group": { "any_ae": "0" }, "No ketamine group": { "any_ae": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT02422303", "date": null }, "note": "Registry posted results only. The primary outcome (Goldberg Depression Screening Test, one week) lists 0 analysed in each arm and no values, so there are no depression entries; analysed '0' is that printed count. Participant flow: STARTED 6/6, COMPLETED 5/5. any_ae '0' stands for the registry's printed 'serious 0/6, other 0/6' in each arm. Registry label 'No Ketamine Group' is the design's 'No ketamine group'. No enrollment dates given.", "decided_by": "both coders" }, { "trial": "T014", "source": "abstract", "arms": { "Group K": { "randomized": null, "analysed": null }, "Group C": { "randomized": null, "analysed": null } }, "depression": [], "pain": [ { "measure": "VAS pain in PACU, at 4 h, 24 h and days 2-5", "day": 1, "form": "mean_sd", "location": "abstract", "values": { "Group K": { "mean": "2.4", "sd": "0.5", "n": null }, "Group C": { "mean": "2.6", "sd": "0.5", "n": null } } }, { "measure": "VAS pain in PACU, at 4 h, 24 h and days 2-5", "day": 2, "form": "mean_sd", "location": "abstract", "values": { "Group K": { "mean": "2.0", "sd": "0.4", "n": null }, "Group C": { "mean": "2.3", "sd": "0.5", "n": null } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2015-06", "end": "2016-05" }, "registration": null, "note": "Abstract only. 66 randomized in total; per-arm numbers not given (by 6 months 2 lost in group C, 1 in group K). HADS (preoperative, day 5, 3 and 6 months) reported only by significance statements, so no depression entries. The abstract lists VAS in the order PACU, 4 h, 24 h, 2 d, 3 d, 4 d, 5 d: group K (2.5±0.8), (2.4±0.5), (2.4±0.5), (2.0±0.4), (1.5±0.5), (1.0±0.4), 1(1); group C (2.9±1.0), (2.9±0.6), (2.6±0.5), (2.3±0.5), (1.8±0.6), (1.5±0.5), 1(0); day 1 is the 24 h value and day 2 the '2 d' value. '±' is not defined and is read as mean ± SD; no n is given for VAS. Analgesic consumption only as 'lower (all P<0.05)'. PMPS incidence at 3 and 6 months (25% and 22% vs 52% and 45%) is outside the day 1-2 pain window. No adverse events reported. Enrollment from the abstract's Methods ('From June 2015 to May 2016').", "decided_by": "third reader" }, { "trial": "T015", "source": "library", "arms": { "Ketamine group": { "randomized": null, "analysed": "162" }, "Saline group": { "randomized": null, "analysed": "163" } }, "depression": [ { "measure": "EPDS", "day": 3, "form": "mean_sd", "location": "Table 4", "values": { "Ketamine group": { "mean": "7.2", "sd": "3.9", "n": "162" }, "Saline group": { "mean": "7.2", "sd": "4.2", "n": "163" } } }, { "measure": "EPDS", "day": 3, "form": "count", "definition": "EPDS ≥ 10 ('occurrence of postpartum depression', the primary outcome's threshold)", "location": "Table 4", "values": { "Ketamine group": { "events": "41", "n": "162" }, "Saline group": { "events": "46", "n": "163" } } }, { "measure": "EPDS", "day": 42, "form": "mean_sd", "location": "Table 4", "values": { "Ketamine group": { "mean": "5.6", "sd": "3.9", "n": "162" }, "Saline group": { "mean": "5.7", "sd": "4.3", "n": "163" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "EPDS ≥ 10 ('occurrence of postpartum depression', the primary outcome's threshold)", "location": "Table 4", "values": { "Ketamine group": { "events": "26", "n": "162" }, "Saline group": { "events": "29", "n": "163" } } } ], "pain": [], "adverse_events": [ { "window": "intraoperative", "time": "5 min after dosing", "location": "Table 3, 5 min", "values": { "Ketamine group": { "hallucination": "37", "dizziness": "113", "visual": "31" }, "Saline group": { "hallucination": "0", "dizziness": "16", "visual": "0" } } }, { "window": "intraoperative", "time": "15 min after dosing", "location": "Table 3, 15 min", "values": { "Ketamine group": { "hallucination": "8", "dizziness": "79", "visual": "14" }, "Saline group": { "hallucination": "0", "dizziness": "10", "visual": "1" } } }, { "window": "intraoperative", "time": "immediately before leaving the operating room", "location": "Table 3, out of operation room", "values": { "Ketamine group": { "hallucination": "3", "dizziness": "17", "visual": "4" }, "Saline group": { "hallucination": "0", "dizziness": "8", "visual": "3" } } } ], "blinding_check": null, "enrollment": { "start": "2015-10-08", "end": "2016-03-10" }, "registration": { "number": "ChiCTR-IPR-15007159", "date": null }, "note": "Randomized per arm not printed (330 enrolled and randomized 1:1; per-arm numbers are only in the flow chart, Figure 1, which has no values in the text). 1 subject missed the 3-day visit and 4 were lost by 6 weeks; 325 analysed (Ketamine 162, Saline 163, as in every table's header). Day 42 = '6 week postpartum'. Depression from Table 4: EPDS mean ± SD and 'occurrence of postpartum depression' (EPDS ≥ 10); both forms are given at each time. Pain: NRS only at 3 days (4 (0–7) vs 4 (0–8), median (range)) and 6 weeks (1 (0–8) vs 2 (0–9); NRS ≤3 129 vs 111, >3 33 vs 52), outside the day 1/2 windows, so not extracted. Adverse events: Table 3 ('Side effects after administration during the operation'; drug given within 5 min of cord clamping) counts patients at each of three checks (5 and 15 min after dosing, and just before leaving the operating room), one entry per check, named in 'time'; a patient can appear at more than one check, so the entries are not to be summed. Diplopia coded visual. Also in Table 3 (5 min, 15 min, leaving; Ketamine vs Saline), not codebook categories: vomiting 3/1, 7/1, 1/2; headache 8/1, 4/0, 3/0; drowsiness 71/4, 26/2, 5/1; Ramsay score >3 15/0, 0/0, 0/0. The Discussion says side effects were not fully documented after the operating room and that no adverse events associated with ketamine were found during postoperative follow-up (no counts). Enrollment dates are from Methods ('conducted from October 8, 2015 to March 10, 2016'); registration has no date.", "decided_by": "third reader" }, { "trial": "T016", "source": "fulltext", "arms": { "Lo-K": { "randomized": null, "analysed": "226" }, "Hi-K": { "randomized": null, "analysed": "223" }, "Placebo (P)": { "randomized": null, "analysed": "221" } }, "depression": [ { "measure": "PHQ-8", "day": -1, "form": "median_iqr", "location": "Table 2 (Preoperative PHQ-8 score, Median (IQR))", "values": { "Lo-K": { "median": "2", "q1": "0", "q3": "6", "n": "226" }, "Hi-K": { "median": "2", "q1": "0", "q3": "5", "n": "223" }, "Placebo (P)": { "median": "2", "q1": "0", "q3": "5", "n": "221" } } }, { "measure": "PHQ-8", "day": -1, "form": "count", "definition": "PHQ-8 ≥ 10 (symptoms suggestive of depression)", "location": "Table 3 (Preoperative)", "values": { "Lo-K": { "events": "24", "n": "226" }, "Hi-K": { "events": "22", "n": "223" }, "Placebo (P)": { "events": "18", "n": "221" } } }, { "measure": "PHQ-8", "day": 3, "form": "count", "definition": "PHQ-8 ≥ 10 (symptoms suggestive of depression)", "location": "Table 3 (POD3)", "values": { "Lo-K": { "events": "32", "n": "180" }, "Hi-K": { "events": "29", "n": "169" }, "Placebo (P)": { "events": "23", "n": "156" } } }, { "measure": "PHQ-8", "day": 30, "form": "count", "definition": "PHQ-8 ≥ 10 (symptoms suggestive of depression)", "location": "Table 3 (POD30)", "values": { "Lo-K": { "events": "9", "n": "130" }, "Hi-K": { "events": "14", "n": "128" }, "Placebo (P)": { "events": "24", "n": "137" } } } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT01690988", "date": null }, "note": "Secondary analysis of PODCAST. Arm numbers are those analysed (Tables 1-2 'Sample size' 221/226/223 of 670); per-arm randomized numbers are only in Fig. 1, which is not reproduced. The baseline is entered twice: the Table 2 median (IQR) and the Table 3 count of PHQ-8 >= 10. Table 2's 'Mean (sd)' row prints 3.1 (0-5), 3.6 (0-6), 3.3 (0-5) for Placebo, Lo-K, Hi-K (all groups 3.3 (3.9)); the parenthesised values repeat the IQRs, so no usable SD is printed and the Median (IQR) row was taken instead (ranges 0-16, 0-22, 0-14). POD30 is 'approximately 1 month after surgery'. Continuous postoperative PHQ-8 is given only as combined ketamine (Lo-K plus Hi-K) vs placebo Hodges-Lehmann median differences: POD3 0 (95% CI -1.0 to 1.0, P=0.773), POD30 0 (95% CI 0.0-1.0, P=0.271); per-group scores are only in Fig. 2 (no printed values), so not recorded. Methods say 165 missing at POD3 and 375 at POD30; Table 3 has 505 and 395 assessed of 670. No adverse events, enrollment dates, or blinding check in this report.", "decided_by": "third reader" }, { "trial": "T017", "source": "library", "arms": { "group D": { "randomized": "99", "analysed": "95" }, "group KD": { "randomized": "99", "analysed": "94" } }, "depression": [], "pain": [ { "measure": "100-mm VAS pain at 1, 6, 24, 48 h (rest or movement not stated)", "day": 1, "form": "mean_sd", "location": "Table 2, row VAS 24 h", "values": { "group D": { "mean": "34.9", "sd": "7.7", "n": "95" }, "group KD": { "mean": "30.9", "sd": "6.7", "n": "94" } } }, { "measure": "100-mm VAS pain at 1, 6, 24, 48 h (rest or movement not stated)", "day": 2, "form": "mean_sd", "location": "Table 2, row VAS 48 h", "values": { "group D": { "mean": "23.8", "sd": "6.3", "n": "95" }, "group KD": { "mean": "22.8", "sd": "5.9", "n": "94" } } }, { "measure": "PCA (morphine, ketorolac) consumption over 24 h", "day": 1, "form": "mean_sd", "location": "Table 2, row PCA consumption for 24 after surgery", "values": { "group D": { "mean": "65.3", "sd": "5.2", "n": "95" }, "group KD": { "mean": "61.1", "sd": "7.2", "n": "94" } } } ], "adverse_events": [ { "window": "overall", "location": "Table 2, row Hallucination", "values": { "group D": { "hallucination": "0" }, "group KD": { "hallucination": "3" } } } ], "blinding_check": null, "enrollment": { "start": "2017-08", "end": "2018-01" }, "registration": { "registry": "clinicaltrials.gov", "number": "NCT03194594", "date": null }, "note": "Depression: PHQ-9 was measured before surgery and on postoperative days 1 and 3, but its values appear only in Fig. 2, and the text holds only the figure's caption ('Perioperative change of Patient Health Questionnaire (PHQ)-9 scores'), no printed values; the Results and abstract give only P values (groups K and KD lower on days 1 and 3 than before surgery and than group D, P < 0.01; group D unchanged; K and KD not different), so no depression entry is recorded. The 3.10, 3.50 and 2.95 (SD 0.67) in Methods are hypothesized means from a preliminary investigation for the sample size, not results. Arms: group K (ketamine alone, design role other) is left out. Randomized n = 99 per group (Methods and abstract); analysed n and every value's n are Table 2's column headers (group K 92, group D 95, group KD 94). The Results say 297 received study medication after randomization and 16 were withdrawn (conversion to open surgery, loss to follow-up, re-exploration for postoperative bleeding, refusal of postoperative assessment; Fig. 1, whose per-arm counts are not in the text). Pain: Table 2 heads the VAS rows 'Pain intensity with effort', so these are scores with effort, although the design's measure name says rest or movement not stated. VAS at 1 h and 6 h (day 0) are left out under the codebook's 24/48 h rule. Table 2 prints no unit for 'PCA consumption for 24 after surgery'; the PCA pump held morphine 60 mg, ketorolac 150 mg and ramosetron 0.6 mg in 100 ml saline (basal 2 ml/h, 0.5-ml boluses, 15-min lockout). Table 2 marks group KD's VAS at 1, 6 and 24 h with * (P < 0.01 vs group K) and its PCA value with ** (P < 0.05 vs the other two groups); the markers are dropped from the values. Adverse events: hallucination is printed as n (%) in Table 2 (group D 0 (0), group KD 3 (3.2)); the row alignment checks out, since genital pruritus (0, 4, 3) occurs only in the dexamethasone groups and hallucination (2, 0, 3) only in the ketamine groups. No time is stated for hallucination anywhere: the Methods list 'side effects of the study drugs' as a secondary outcome with no time, and the Results report them with age, weight and anesthesia duration, apart from PONV. In the extracted table its label lines up with the timed PONV rows (at 1, 6, 24, 48 h after surgery) but is not one of them. Ketamine was given under general anesthesia, so the count may include emergence reactions, which the codebook keeps apart from postoperative ones; it is coded overall. Table 2 also gives PONV at 1, 6, 24 and 48 h and genital pruritus, outside the codebook's categories; no other psychotomimetic event and no count of any adverse event is reported. No blinding check is reported (only 'double-blinded method'). Enrollment: the Results give no dates; these are from Methods ('The study was performed at University Hospital from August 2017 to January 2018'). Registration: NCT03194594 at clinicaltrials.gov, no registration date printed; 'Registration No. 3031' is the IRB approval (April 2016), not a trial registration. The batch text holds the Methods and Results twice (an excerpt and the full PDF text), and the copies agree.", "decided_by": "third reader" }, { "trial": "T018", "source": "library", "arms": { "Ketamine group": { "randomized": null, "analysed": "327" }, "Control group (no injection; PCIA without ketamine)": { "randomized": null, "analysed": "327" } }, "depression": [ { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": -1, "form": "count", "definition": "EPDS > 9 (antenatal depressive symptom, assessed at gestational weeks 36-40)", "location": "Table 1, 'Antenatal depressive symptom: Yes'", "values": { "Ketamine group": { "events": "122", "n": null }, "Control group (no injection; PCIA without ketamine)": { "events": "116", "n": null } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 4, "form": "mean_sd", "location": "Table 2, '4 days postpartum: EPDS score'", "values": { "Ketamine group": { "mean": "4.27", "sd": "3.8", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "mean": "5.17", "sd": "4.6", "n": "327" } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 4, "form": "count", "definition": "EPDS > 9 (postpartum blues)", "location": "Table 2, '4 days postpartum: Prevalence of postpartum blues'", "values": { "Ketamine group": { "events": "39", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "events": "60", "n": "327" } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 42, "form": "mean_sd", "location": "Table 2, '42 days postpartum: EPDS score'", "values": { "Ketamine group": { "mean": "4.90", "sd": "4.3", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "mean": "5.55", "sd": "5.0", "n": "327" } } }, { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "day": 42, "form": "count", "definition": "EPDS > 9 (postpartum depression)", "location": "Table 2, '42 days postpartum: Prevalence of postpartum depression'", "values": { "Ketamine group": { "events": "42", "n": "327" }, "Control group (no injection; PCIA without ketamine)": { "events": "64", "n": "327" } } } ], "pain": [ { "measure": "NRS postoperative pain", "day": 1, "form": "mean_sd", "location": "Results 3.3 (Secondary outcomes), text", "values": { "Ketamine group": { "mean": "1.85", "sd": null, "n": null }, "Control group (no injection; PCIA without ketamine)": { "mean": "1.77", "sd": null, "n": null } } }, { "measure": "NRS postoperative pain", "day": 2, "form": "mean_sd", "location": "Results 3.3 (Secondary outcomes), text", "values": { "Ketamine group": { "mean": "1.20", "sd": null, "n": null }, "Control group (no injection; PCIA without ketamine)": { "mean": "1.22", "sd": null, "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "values": { "Ketamine group": { "dizziness": "18", "hallucination": "4", "visual": "11" }, "Control group (no injection; PCIA without ketamine)": { "dizziness": "14" } } } ], "blinding_check": null, "enrollment": { "start": "2014-08", "end": "2016-12" }, "registration": { "number": "ChiCTR-ROC-17,012,944", "date": null }, "note": "Randomized per arm not printed: 702 recruited, 654 'included' (Fig. 1 flow chart not reproduced); all 654 completed follow-up and Table 2's 'Number' row gives 327 per arm, used as analysed and as n for Table 2 rows. Table 2 labels the times '4 days postpartum' and '42 days postpartum' (Methods: follow-up at 4-6 days and 6-8 weeks); days recorded as printed (4, 42). Table 2 footnote: values are mean ± SD or number (%). Day -1 count is Table 1's antenatal EPDS > 9 (gestational weeks 36-40); Table 1 prints no column n and the control percentage is garbled as '35,.5'. NRS: text gives only means for the first and second postoperative days, no SD or n. Adverse events are those 'during the operation'; ketamine 'nystagmus in 11 (3.4%)' coded as visual. Text says 'No other adverse reactions were observed in the control group' and 'During PCIA time, no obvious adverse reactions were found in both groups', i.e. no hallucination or nystagmus in control and none postoperatively, but no zeros are printed, so they are left out. Enrollment period is from Methods 2.1 (Results do not state it). Registration printed as 'ChiCTR-ROC-17,012,944' (commas as printed), no registration date; ethics approval February 20, 2014.", "decided_by": "both coders" }, { "trial": "T019", "source": "library", "arms": { "Ketamine": { "randomized": "50", "analysed": "44" }, "Placebo (0.9% saline)": { "randomized": "50", "analysed": "46" } }, "depression": [], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "Ketamine": { "hallucination": "2", "dizziness": "5", "any_ae": "5" }, "Placebo (0.9% saline)": { "hallucination": "0", "dizziness": "1", "any_ae": "3" } } } ], "blinding_check": null, "enrollment": { "start": "2014-10", "end": "2018-01" }, "registration": { "number": "NCT02452060", "date": null }, "note": "Randomized and analysed from the CONSORT flow chart (Ketamine: 50 allocated, 5 withdrew consent before the drug, 1 excluded for a postoperative surgical complication, 44 analysed; placebo: 50, 3, 1, 46). Depression: BDI and MADRS (baseline, PODs 1, 2, 7) appear only in Figure 3 (mean and bootstrap SE) with no values printed; the text gives only P values (BDI group-by-time P = 0.389; MADRS P = 0.674), so no entry. Pain: VAS and SF-MPQ appear only in Figure 2 (no printed values). The abstract's SF-MPQ affective 'mean difference = 2.2 (95% bootstrap CI 2.9 to 1.6)' is the ketamine group's own change from PACU to POD 2 (minus signs apparently lost), not a difference between arms; the between-arm POD 2 comparison has only P = 0.022. Postoperative opioid use (Table 2, mg/kg morphine equivalents) covers the whole hospital stay, not day 1 or 2. Adverse events (Table 3, timing not stated; drug given in the PACU): visual hallucinations coded hallucination, dizziness/lightheadedness coded dizziness; any_ae from Table 3's footnote ('Three patients in the placebo group and five in the ketamine group complained of side effects'). Table 3 also gives euphoria 2 vs 0, dysphoria 2 vs 0, nausea 2 vs 2, and headache 1 vs 0; the Discussion counts 'psychiatric side effects in the ketamine group (5/44)', with no placebo figure. Enrollment is from the abstract's Setting (October 2014 to January 2018).", "decided_by": "both coders" }, { "trial": "T020", "source": "fulltext", "arms": { "Ketamine": { "randomized": "165", "analysed": "153" }, "Placebo (saline)": { "randomized": "165", "analysed": "155" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "mean_sd", "location": "Table 2", "values": { "Ketamine": { "mean": "7.5", "sd": "2.2", "n": "153" }, "Placebo (saline)": { "mean": "8.2", "sd": "2.0", "n": "155" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "count", "definition": "EPDS > 9", "location": "Table 2", "values": { "Ketamine": { "events": "20", "n": "153" }, "Placebo (saline)": { "events": "35", "n": "155" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "mean_sd", "location": "Table 2", "values": { "Ketamine": { "mean": "7.4", "sd": "2.0", "n": "153" }, "Placebo (saline)": { "mean": "7.8", "sd": "2.1", "n": "155" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "count", "definition": "EPDS > 9", "location": "Table 2", "values": { "Ketamine": { "events": "18", "n": "153" }, "Placebo (saline)": { "events": "26", "n": "155" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 30, "form": "mean_sd", "location": "Table 2", "values": { "Ketamine": { "mean": "7.3", "sd": "2.1", "n": "153" }, "Placebo (saline)": { "mean": "7.5", "sd": "2.2", "n": "155" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 30, "form": "count", "definition": "EPDS > 9", "location": "Table 2", "values": { "Ketamine": { "events": "16", "n": "153" }, "Placebo (saline)": { "events": "22", "n": "155" } } } ], "pain": [ { "measure": "NRS pain at 2 days", "day": 2, "form": "mean_sd", "location": "Table 2 (NRS score, wound pain)", "values": { "Ketamine": { "mean": "3.0", "sd": "0.9", "n": "153" }, "Placebo (saline)": { "mean": "4.0", "sd": "1.0", "n": "155" } } } ], "adverse_events": [ { "window": "intraoperative", "time": "5 min after dosing", "location": "Table 3", "values": { "Ketamine": { "hallucination": "24", "dizziness": "56" }, "Placebo (saline)": { "hallucination": "0", "dizziness": "0" } } }, { "window": "intraoperative", "time": "15 min after dosing", "location": "Table 3", "values": { "Ketamine": { "hallucination": "6", "dizziness": "34" }, "Placebo (saline)": { "hallucination": "0", "dizziness": "2" } } }, { "window": "intraoperative", "time": "Out of operation room (asked before leaving the operating room)", "location": "Table 3", "values": { "Ketamine": { "hallucination": "1", "dizziness": "2" }, "Placebo (saline)": { "hallucination": "0", "dizziness": "1" } } } ], "blinding_check": null, "enrollment": { "start": "2019-06-26", "end": "2019-07-15" }, "registration": { "number": "ChiCTR1900022464", "date": null }, "note": "The ± in Tables 1 and 2 and the Results is not defined anywhere in the source; read as mean ± SD. n in each entry is Table 2's column header (Ketamine n = 153, Saline n = 155), which matches the analysed numbers in the Results; 165 were randomized per arm (12 and 10 lost to follow-up). No baseline EPDS is reported. At each time Table 2 gives the EPDS score (mean ± SD) and the 'Occurrence of postpartum depression', defined in the Methods as an EPDS score > 9, so each time has a mean_sd and a count entry. Pain: the design lists one measure, 'NRS pain at 2 days', and Table 2 reports two NRS scores at 2 days postpartum: wound pain, entered under the design's name, and uterine contraction pain (Ketamine 3.0 ± 0.9, Saline 4.1 ± 0.9, n 153 and 155, p < .001), which is not a design measure and is not entered. Adverse events: Table 3 gives counts at three assessments during the operation (5 and 15 min after the study drug, and before leaving the operating room), not the number of participants with each event over the operation, so each assessment is its own entry, and a participant may be counted at more than one. Headache and vomiting are also in Table 3 but are not codebook categories. Spinal anaesthesia; ketamine 0.25 mg/kg or saline within 5 min after cord clamping.", "decided_by": "third reader" }, { "trial": "T021", "source": "fulltext", "arms": { "Control group": { "randomized": "105", "analysed": "105" }, "Racemic ketamine group": { "randomized": "104", "analysed": "104" }, "High-dose S-ketamine group": { "randomized": "104", "analysed": "104" }, "Low-dose S-ketamine group": { "randomized": "104", "analysed": "104" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "mean_sd", "location": "Table 1 (same values in Results, Patients' characteristics)", "values": { "Control group": { "mean": "15.78", "sd": "4.81", "n": "105" }, "Racemic ketamine group": { "mean": "16.20", "sd": "4.86", "n": "104" }, "High-dose S-ketamine group": { "mean": "15.75", "sd": "4.58", "n": "104" }, "Low-dose S-ketamine group": { "mean": "16.69", "sd": "4.96", "n": "104" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 2, 1-month complications ('Dizzy')", "values": { "Control group": { "dizziness": "12" }, "Racemic ketamine group": { "dizziness": "13" }, "High-dose S-ketamine group": { "dizziness": "14" }, "Low-dose S-ketamine group": { "dizziness": "12" } } } ], "blinding_check": null, "enrollment": { "start": "2015-04", "end": "2018-07" }, "registration": null, "note": "Postoperative HAMD-17 and VAS (days 1, 2, 3, 5, 7) appear only in Figures 2 and 1, whose captions print no values, so only baseline HAMD-17 is recorded and pain is empty (Table 1's baseline VAS is not a requested time). Randomized numbers are from Methods; analysed are the table headers, and Results say no patient was lost to follow-up or withdrew. Enrollment dates are from Methods ('enrolled ... from April 2015 to July 2018'); Results give none. Table 2 complications are the 1-month rates; nausea and vomiting are not recorded categories.", "decided_by": "both coders" }, { "trial": "T022", "source": "fulltext", "arms": { "C group": { "randomized": null, "analysed": "153" }, "S group (S-ketamine)": { "randomized": null, "analysed": "122" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": -1, "form": "mean_sd", "location": "Table 1", "values": { "C group": { "mean": "6.54", "sd": "2.35", "n": "153" }, "S group (S-ketamine)": { "mean": "6.72", "sd": "2.25", "n": "122" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 3, "form": "mean_sd", "location": "Results, Secondary outcome paragraph", "values": { "C group": { "mean": "7.65", "sd": "3.14" }, "S group (S-ketamine)": { "mean": "6.00", "sd": "2.47" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "mean_sd", "location": "Results, Secondary outcome paragraph", "values": { "C group": { "mean": "7.62", "sd": "3.14" }, "S group (S-ketamine)": { "mean": "6.38", "sd": "2.67" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 3, "form": "percent", "definition": "EPDS ≥ 10", "location": "Results, Primary outcome paragraph", "values": { "C group": { "percent": "24.2" }, "S group (S-ketamine)": { "percent": "17.6" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "percent", "definition": "EPDS ≥ 10", "location": "Results, Primary outcome paragraph", "values": { "C group": { "percent": "9.8" }, "S group (S-ketamine)": { "percent": "8.2" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "C group": { "dizziness": "14" }, "S group (S-ketamine)": { "dizziness": "15" } } } ], "blinding_check": null, "enrollment": { "start": "2019-09-01", "end": "2020-07-15" }, "registration": { "number": "ChiCTR2100050263", "date": "2021-08-24" }, "note": "Randomized per arm not printed (451 recruited; 71 vaginal delivery, 53 refused after cesarean delivery, 52 lost to follow-up; 275 analysed: Table 1 n = 153 C, 122 S). Baseline EPDS (day of surgery, before it): the Results text says 'similar between the S group and C group before delivery (6.54 ± 2.35 vs. 6.72 ± 2.25, P = 0.508)', naming S first, but Table 1 puts 6.54 ± 2.35 under C group and 6.72 ± 2.25 under S group (P 0.48); Table 1 taken. ARM AMBIGUITY: the day 3 and day 14 EPDS means are in the text only, without arm labels ('at 3 days (7.65 ± 3.14 vs. 6.00 ± 2.47)' and '14 days (7.62 ± 3.14 vs. 6.38 ± 2.67)'); assigned C first, S second, the order of the baseline pair in the same paragraph (which Table 1 shows is C then S), which also fits the S group's lower depression rate; please check. The depression rates (primary outcome, EPDS ≥ 10) are printed only as percentages, so they are entered in form 'percent' with no events or n; that sentence names the S group first ('lower in the S group ... (17.6 and 8.2% vs. 24.2 and 9.8%)'). n at days 3 and 14 is not printed; S's 17.6% at day 3 is not a whole number out of 122 (21/122 is 17.2%, 22/122 is 18.0%), so its denominator is not the analysed 122 or the figure is misprinted. Day 28 EPDS scores and rates appear only in Figs. 2 and 3 with no printed values. VAS appears only in Fig. 4a with no printed values, so no pain entries (RSS is sedation). AEs were recorded during the 48 h PCIA (Table 2); only 'Dizzy' maps to a codebook category (headache, nausea, drowsiness and vomiting are not coded). Registered retroactively on 2021-08-24, after enrollment ended (Results: recruited September 1, 2019 to July 15, 2020).", "decided_by": "third reader" }, { "trial": "T023", "source": "abstract", "arms": { "Group C": { "randomized": null, "analysed": "49" }, "Group K": { "randomized": null, "analysed": "48" } }, "depression": [], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": null, "registration": null, "note": "Abstract only. 100 randomized 1:1; per-arm randomized numbers not printed. 'analysed' is the number with the primary outcome (QoR-40 on POD1) available, 49 in group C and 48 in group K; no analysed numbers are given for HADS or NRS. HADS (2 days, 3 months), NRS (4, 24, 48 h) and chronic pain are reported only as no difference between groups (p > .15 for each), without numbers. A post hoc QoR-40 pain subsection score on POD1 ('pain scores were significantly higher in group K than in group C (29.8 ± 3.8 vs. 31.7 ± 2.1, 95% CI -1.81 (-3.00, -0.62), p = .003)'; a recovery subscale, higher is better, its arm order ambiguous as printed) is not a design pain measure and is not entered. No adverse events, dates or registration given.", "decided_by": "third reader" }, { "trial": "T024", "source": "fulltext", "arms": { "R (ropivacaine alone)": { "randomized": null, "analysed": "40" }, "RS (ropivacaine with IV S-ketamine)": { "randomized": null, "analysed": "40" } }, "depression": [ { "measure": "EPDS at discharge", "day": -1, "form": "mean_sd", "location": "Table 1, 'EPDS scores at admission' (day before surgery)", "values": { "R (ropivacaine alone)": { "mean": "3.5", "sd": "2.5", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "2.9", "sd": "2.3", "n": "40" } } }, { "measure": "EPDS at discharge", "day": null, "form": "mean_sd", "location": "Table 4, 'EPDS scores at discharge'", "values": { "R (ropivacaine alone)": { "mean": "4.1", "sd": "3.0", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "2.3", "sd": "2.5", "n": "40" } } } ], "pain": [ { "measure": "analgesic effect at 24 and 48 h", "day": 1, "form": "mean_sd", "location": "Table 4, 'Resting VAS at 24H'", "values": { "R (ropivacaine alone)": { "mean": "3.4", "sd": "0.9", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "1.4", "sd": "1.1", "n": "40" } } }, { "measure": "analgesic effect at 24 and 48 h", "day": 1, "form": "mean_sd", "location": "Table 4, 'Mobile VAS at 24H'", "values": { "R (ropivacaine alone)": { "mean": "5.9", "sd": "1.3", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "3.8", "sd": "1.3", "n": "40" } } }, { "measure": "analgesic effect at 24 and 48 h", "day": 1, "form": "mean_sd", "location": "Table 4, 'PCA times during 24H'", "values": { "R (ropivacaine alone)": { "mean": "2.2", "sd": "2.3", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "1.7", "sd": "1.8", "n": "40" } } }, { "measure": "analgesic effect at 24 and 48 h", "day": 2, "form": "mean_sd", "location": "Table 4, 'Resting VAS at 48H'", "values": { "R (ropivacaine alone)": { "mean": "1.8", "sd": "0.7", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "0.7", "sd": "0.8", "n": "40" } } }, { "measure": "analgesic effect at 24 and 48 h", "day": 2, "form": "mean_sd", "location": "Table 4, 'Mobile VAS at 48H'", "values": { "R (ropivacaine alone)": { "mean": "3.4", "sd": "1.1", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "2.2", "sd": "1.1", "n": "40" } } }, { "measure": "analgesic effect at 24 and 48 h", "day": 2, "form": "mean_sd", "location": "Table 4, 'PCA times during 24-48H'", "values": { "R (ropivacaine alone)": { "mean": "0.7", "sd": "0.8", "n": "40" }, "RS (ropivacaine with IV S-ketamine)": { "mean": "0.4", "sd": "0.9", "n": "40" } } } ], "adverse_events": [ { "window": "intraoperative", "location": "Table 4, Peri-operative outcomes", "values": { "R (ropivacaine alone)": { "nightmare": "0", "visual": "0", "dizziness": "1" }, "RS (ropivacaine with IV S-ketamine)": { "nightmare": "25", "visual": "0", "dizziness": "21" } } } ], "blinding_check": null, "enrollment": { "start": "2021-01", "end": "2021-04" }, "registration": { "number": "ChiCTR2000040375", "date": "2020-11-28" }, "note": "Sequential (biased-coin up-and-down) dose-finding study: IV S-ketamine 0.15 mg/kg or saline 1 min before surgery under combined spinal-epidural anaesthesia. 85 women recruited and allocated; 40 per group analysed (randomized per arm not stated; Fig. 1 not printed). The design names the measure 'EPDS at discharge'; the baseline EPDS (at admission, the day before surgery) is given under the same name with day -1. The discharge day is not stated, so that entry's day is null. The design's 'analgesic effect at 24 and 48 h' is reported as three Table 4 rows (Resting VAS, Mobile VAS, PCA times), each entered under the design's name with the row named in location, resting VAS first. 'PCA times during 24-48H' is the count within 24-48 h, not cumulative to 48 h. Adverse events are from Table 4 'Peri-operative outcomes' in women awake under neuraxial anaesthesia (coded intraoperative): 'Dreaming' coded nightmare (the source does not say the dreams were unpleasant), 'Blurred vision' coded visual. Not mapped: the sedation scale's 'agitated' (score 1) counts, RS vs R, before delivery 0 vs 12, 5 min after delivery 0 vs 3, end of surgery 0 vs 0, which are sedation levels rather than adverse events. Enrollment period is from Methods ('recruited during January 2021 and April 2021'; Results don't state it); registration date printed 28/11/2020. Results text gives 'Duration of first PCA' in the reverse group order to Table 4 (not extracted).", "decided_by": "third reader" }, { "trial": "T025", "source": "library", "arms": { "Ketamine group": { "randomized": "41", "analysed": "41" }, "Placebo group (normal saline)": { "randomized": "43", "analysed": "43" } }, "depression": [ { "measure": "MADRS (also at discharge)", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Ketamine group": { "median": "28", "q1": "26", "q3": "31", "n": "41" }, "Placebo group (normal saline)": { "median": "27", "q1": "25", "q3": "31", "n": "43" } } }, { "measure": "MADRS (also at discharge)", "day": 2, "form": "mean_sd", "location": "Results, Primary and Secondary Outcomes, second paragraph", "values": { "Ketamine group": { "mean": "16", "sd": "9" }, "Placebo group (normal saline)": { "mean": "21", "sd": "9" } } }, { "measure": "MADRS (also at discharge)", "day": 3, "form": "count", "definition": "responders: MADRS reduction ≥ 50% from baseline (the primary outcome; a count of responders, not of participants with depression)", "location": "Table 3 (also abstract: 17/41 vs 7/43)", "values": { "Ketamine group": { "events": "17", "n": "41" }, "Placebo group (normal saline)": { "events": "7", "n": "43" } }, "counts": "improvement" }, { "measure": "PHQ-9 (also at discharge)", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Ketamine group": { "median": "13", "q1": "11", "q3": "15", "n": "41" }, "Placebo group (normal saline)": { "median": "13", "q1": "12", "q3": "15", "n": "43" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 3, Psychiatric outcomes (postoperative day 3)", "values": { "Ketamine group": { "dissociation": "3" }, "Placebo group (normal saline)": { "dissociation": "1" } } } ], "blinding_check": null, "enrollment": { "start": "2017-07-05", "end": "2018-08-21" }, "registration": { "number": "NCT03086148", "date": null }, "note": "ITT: all 84 analysed after imputing missing postoperative scores (baseline values for 9 subjects at day 1, 7 at day 2 and 2 at day 3; last observation carried forward for 3 at discharge), so no per-time n is printed for the day 2 means. Baseline (Table 1) was 1 day before surgery (day -1). Day 2 MADRS '16 [SD = 9] vs 21 [SD = 9]' are means (Figure 2 plots means with SD). Day 1 and day 3 MADRS and all postoperative PHQ-9 values are only in Figure 2 (no printed values; PHQ-9 P = .036 at day 2 and .015 at day 3). The day 3 count is the primary outcome; its RR is 2.55 (1.18–5.50) in Table 3, 2.25 in the text and 2.51 in the abstract, with the same CI in each. Not entered: response at day 2, given only as percentages (43.9% vs 20.0%); the MADRS reduction from baseline at day 3, '11 vs 7, respectively; 95% CI, −0.51 to 7.96' (no estimate of the difference printed; whether means or medians not stated); outcomes at discharge, which has no fixed day (hospital stay 7 (6–9) vs 8 (6–10) days): response 16 (39.0) vs 9 (20.9), RR 1.86 (0.93–3.74), and remission (MADRS ≤ 10) 12 (29.3) vs 3 (7.0), RR 4.20 (1.28–13.80). Pain: only cumulative severe pain (NRS ≥5) over the first 3 postoperative days, 19 (47.5) vs 17 (39.5), not at day 1 or 2, so not entered (47.5% does not match 19/41). AEs: Table 3's psychiatric outcomes are on postoperative day 3; dissociative symptoms (CADSS ≠ 0) coded dissociation. Not coded: delirium on day 1 by CAM-ICU, 1 (2.4) vs 3 (7.0), RR 0.35 (0.04–3.23), a secondary outcome not described as agitation or excitement and not on emergence (psychiatric_any does not apply, as specific psychiatric counts are given); manic symptoms (YMRS ≥5) 2 (4.9) vs 1 (2.3); psychotic symptoms (4 BPRS items incl. hallucinations, ≥5) 3 (7.3) vs 4 (9.3), not specific to hallucinations; complications at discharge: aphasia 5 vs 3, epilepsy 1 vs 1, hemorrhage 5 vs 9.", "decided_by": "third reader" }, { "trial": "T026", "source": "fulltext", "arms": { "Group C": { "randomized": "30", "analysed": "30" }, "Group K": { "randomized": "30", "analysed": "30" } }, "depression": [ { "measure": "Profile of Mood States (POMS)", "day": -1, "form": "mean_sd", "location": "Table 4, 'Total depression subscale', Pre", "values": { "Group C": { "mean": "8.4", "sd": "2.8", "n": "30" }, "Group K": { "mean": "8.1", "sd": "2.3", "n": "30" } } }, { "measure": "Profile of Mood States (POMS)", "day": 0, "form": "mean_sd", "location": "Table 4, 'Total depression subscale', Post (2 h postoperatively)", "values": { "Group C": { "mean": "10.2", "sd": "3.4", "n": "30" }, "Group K": { "mean": "5.3", "sd": "1.9", "n": "30" } } } ], "pain": [], "adverse_events": [ { "window": "intraoperative", "location": "Table 5, Diplopia, Intraoperative", "values": { "Group C": { "visual": "0" }, "Group K": { "visual": "9" } } }, { "window": "postoperative", "location": "Table 5, Diplopia, Postoperative", "values": { "Group C": { "visual": "0" }, "Group K": { "visual": "6" } } }, { "window": "overall", "location": "Table 5, Perioperative psychedelic phenomena", "values": { "Group C": { "hallucination": "0", "dissociation": "0" }, "Group K": { "hallucination": "2", "dissociation": "6" } } } ], "blinding_check": null, "enrollment": { "start": "2019-07", "end": "2020-08" }, "registration": { "number": "PACTR201907779292947", "date": "2019-07-16" }, "note": "Randomized per arm taken from the tables' N = 30 (60 participated, 1:1, no losses reported; Fig. 1 not printed). Design code POMS_D, so the entries are Table 4's 'Total depression subscale' (Pre = preoperatively, day -1; Post = 2 h postoperatively, day 0). Total POMS (total mood disturbance, the paper's primary outcome; Table 4) is not a measure the design lists, so not entered: Preoperative K 28.1 ± 8.0, C 27.8 ± 9.5; Postoperative K 11.9 ± 5.4, C 37.3 ± 13.0. Table 5: diplopia coded visual; 'Perioperative psychedelic phenomena' (assessed intraoperatively, during infusion, and/or postoperatively) coded overall; not coded: relaxation 25 vs 0, euphoria 7 vs 0, dysphoria 1 vs 0, headache intraoperative 6 vs 0 and postoperative 7 vs 6 (K vs C). Registration date printed 16/7/2019.", "decided_by": "third reader" }, { "trial": "T027", "source": "fulltext", "arms": { "Intervention group": { "randomized": null, "analysed": "67" }, "Control group": { "randomized": null, "analysed": "67" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": -1, "form": "mean_sd", "location": "Table 2", "values": { "Intervention group": { "mean": "13.78", "sd": "3.87", "n": null }, "Control group": { "mean": "13.79", "sd": "4.78", "n": null } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "mean_sd", "location": "Table 2", "values": { "Intervention group": { "mean": "11.82", "sd": "3.41", "n": null }, "Control group": { "mean": "14.34", "sd": "4.29", "n": null } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 28, "form": "mean_sd", "location": "Table 2", "values": { "Intervention group": { "mean": "10.84", "sd": "3.48", "n": null }, "Control group": { "mean": "13.09", "sd": "3.79", "n": null } } } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": null, "registration": null, "note": "Table 2 names its columns by drug: 'Ketamine-Nesdonal group' (ketamine 0.5 mg/kg with Nesdonal at induction) = Intervention group, 'Nesdonal group' (Nesdonal alone) = Control group, printed Nesdonal first; the Results text's within-group trends (ketamine group falling at 2 and 4 weeks, Nesdonal group rising at 2 weeks) and Table 2's Greenhouse-Geisser F (4.68 Nesdonal, 52.52 Ketamine-Nesdonal) agree with these labels. Times: 'before caesarian section' = day -1, 'two weeks after' = 14, 'four weeks after' = 28 (EPDS by phone). Analysed: the Results say 'In total, 67 participants were studied in both groups'; Table 1's counts sum to 67 in each column (history of depression 15 + 52 and 10 + 57; education 5 + 17 + 45 and 4 + 25 + 38; the control's wanted/unwanted pregnancy row sums to 66), so 67 is per group, not in all. No number randomized per arm (the CONSORT figure's contents are not in the text; 35 per group were planned) and no n per time point. Labelling inconsistency: the Results text gives mean age 27.4±4.09 to the Nesdonal group, while Table 1 gives 27.40 (4.09) to the Intervention group; Table 2 labels its columns by drug, so the outcomes are unaffected. No adverse events, blinding check, enrollment dates or registration are reported.", "decided_by": "third reader" }, { "trial": "T028", "source": "library", "arms": { "Control group (normal saline)": { "randomized": "100", "analysed": "100" }, "Racemic ketamine group": { "randomized": "102", "analysed": "102" }, "S-ketamine group": { "randomized": "101", "analysed": "101" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "mean_sd", "location": "Table 3", "values": { "Control group (normal saline)": { "mean": "17.0", "sd": "2.2", "n": "100" }, "Racemic ketamine group": { "mean": "17.0", "sd": "2.2", "n": "102" }, "S-ketamine group": { "mean": "16.8", "sd": "2.3", "n": "101" } } }, { "measure": "HAMD-17", "day": 3, "form": "mean_sd", "location": "Table 3", "values": { "Control group (normal saline)": { "mean": "16.4", "sd": "2.0", "n": "100" }, "Racemic ketamine group": { "mean": "13.2", "sd": "2.5", "n": "102" }, "S-ketamine group": { "mean": "11.4", "sd": "2.2", "n": "101" } } }, { "measure": "HAMD-17", "day": 7, "form": "mean_sd", "location": "Table 3", "values": { "Control group (normal saline)": { "mean": "11.2", "sd": "3.6", "n": "100" }, "Racemic ketamine group": { "mean": "10.5", "sd": "2.9", "n": "102" }, "S-ketamine group": { "mean": "9.4", "sd": "3.0", "n": "101" } } }, { "measure": "HAMD-17", "day": 30, "form": "mean_sd", "location": "Table 3", "values": { "Control group (normal saline)": { "mean": "11.0", "sd": "3.8", "n": "100" }, "Racemic ketamine group": { "mean": "9.5", "sd": "2.9", "n": "102" }, "S-ketamine group": { "mean": "6.9", "sd": "2.8", "n": "101" } } }, { "measure": "HAMD-17", "day": 90, "form": "mean_sd", "location": "Table 3", "values": { "Control group (normal saline)": { "mean": "7.5", "sd": "3.0", "n": "100" }, "Racemic ketamine group": { "mean": "7.5", "sd": "3.2", "n": "102" }, "S-ketamine group": { "mean": "6.5", "sd": "3.3", "n": "101" } } } ], "pain": [ { "measure": "VAS pain", "day": 1, "form": "mean_sd", "location": "Table 2", "values": { "Control group (normal saline)": { "mean": "4.0", "sd": "0.8", "n": "100" }, "Racemic ketamine group": { "mean": "3.4", "sd": "0.7", "n": "102" }, "S-ketamine group": { "mean": "2.8", "sd": "0.8", "n": "101" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Control group (normal saline)": { "dizziness": "13" }, "Racemic ketamine group": { "dizziness": "11" }, "S-ketamine group": { "dizziness": "12" } } } ], "blinding_check": null, "enrollment": { "start": "2017-06", "end": "2018-06" }, "registration": null, "note": "No patient lost to follow-up; group sizes from Methods, Results, and the table headers. HAMD-17 mean ± SD from Table 3 (baseline also in Table 1); '3 months' entered as day 90. Pain: VAS day 1 from Table 2; days 3 and 7 not extracted. Adverse events: Table 2's 'Complication' rows, timing not stated, coded postoperative; 'Dizzy' coded dizziness; also nausea 16, 18, 20 and vomit 7, 8, 7 (S-ketamine, racemic, control). The percentages printed beside Table 2's S-ketamine and racemic ketamine counts (e.g., 16 (15.7), 18 (17.8), 12 (11.8), 11 (10.9)) fit each other's group sizes rather than their own, so those two columns may be swapped. Enrollment from Methods and abstract ('from June 2017 to June 2018'). No registration given.", "decided_by": "both coders" }, { "trial": "T029", "source": "fulltext", "arms": { "S-ketamine group": { "randomized": "61", "analysed": "60" }, "Placebo group": { "randomized": "63", "analysed": "60" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "mean_sd", "location": "Table 2 (same values in Table 1, n = 60 per group)", "values": { "S-ketamine group": { "mean": "19.0", "sd": "3.59", "n": "60" }, "Placebo group": { "mean": "19.5", "sd": "3.73", "n": "60" } } }, { "measure": "HAMD-17", "day": 7, "form": "mean_sd", "location": "Table 2", "values": { "S-ketamine group": { "mean": "10.7", "sd": "4.80", "n": null }, "Placebo group": { "mean": "15.5", "sd": "5.04", "n": null } } }, { "measure": "HAMD-17", "day": 7, "form": "change_mean_sd", "location": "Table 2", "values": { "S-ketamine group": { "mean": "−8.8", "sd": "3.27", "n": null }, "Placebo group": { "mean": "−3.5", "sd": "2.17", "n": null } } }, { "measure": "PHQ-9", "day": -1, "form": "mean_sd", "location": "Table 2 (same values in Table 1, n = 60 per group)", "values": { "S-ketamine group": { "mean": "15.6", "sd": "2.65", "n": "60" }, "Placebo group": { "mean": "15.2", "sd": "2.45", "n": "60" } } }, { "measure": "PHQ-9", "day": 7, "form": "mean_sd", "location": "Table 2", "values": { "S-ketamine group": { "mean": "8.9", "sd": "3.45", "n": null }, "Placebo group": { "mean": "13.0", "sd": "3.44", "n": null } } }, { "measure": "PHQ-9", "day": 7, "form": "change_mean_sd", "location": "Table 2", "values": { "S-ketamine group": { "mean": "−6.7", "sd": "2.53", "n": null }, "Placebo group": { "mean": "−2.2", "sd": "1.49", "n": null } } } ], "pain": [ { "measure": "opioid use during hospital stay (morphine equivalents)", "day": 2, "form": "mean_sd", "location": "Table 3 ('Postoperative opioid used, mg'); Results text gives the same values as consumption within 2 days after surgery", "values": { "S-ketamine group": { "mean": "16.4", "sd": "5.9", "n": "60" }, "Placebo group": { "mean": "23.9", "sd": "8.4", "n": "60" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 3", "values": { "S-ketamine group": { "dizziness": "5" }, "Placebo group": { "dizziness": "3" } } } ], "blinding_check": null, "enrollment": { "start": "2020-09-01", "end": "2022-03-01" }, "registration": { "number": "NCT05506787", "date": null }, "note": "Randomized 61 (S-ketamine) and 63 (placebo); 1 and 3 lost to follow-up; 60 per arm analysed. Tables list Placebo before S-Ketamine. HAMD-17 and PHQ-9 on days 1, 3 and 30 and NRS on days 1 and 2 are only in Figure 2, with no printed values, so only baseline and day 7 (Table 2) are entered. Table 2 gives no n; the baseline n of 60 is Table 1's header, where the same baseline values are printed with '±' (Table 1's footnote says number (%) and median (IQR); Table 2 labels them Mean (SD)). Change values keep the source's minus sign (U+2212) exactly as printed. The printed HAMD-17 changes (−3.5, −8.8) are not the day-7 minus baseline means (−4.0, −8.3), though their difference matches the printed treatment difference; recorded as printed. Table 2 also gives the day-7 treatment differences, Mean (SE) and 95% CI: HAMD-17 −5.3 (0.50), −6.3 to −4.3; PHQ-9 −4.5 (0.38), −5.2 to −3.7; not entered since arm values are given. Opioid: Methods describe use throughout the hospital stay (morphine equivalents), but the Results text gives the Table 3 values (16.4 [SD 5.9] vs 23.9 [SD 8.4]) as consumption within 2 days after surgery, so day 2 (cumulative). Adverse events from Table 3 (timing not stated; read as postoperative): 'Dizzy' 5 (8.3%) vs 3 (5%) as dizziness; 'Dysphoria' 4 (6.7) vs 1 (1.7%), which the text calls irritability, not coded to a category; nausea 3 (5%) vs 6 (10%) not a codebook category. Enrollment from the Results ('From 1 September 2020 to 1 March 2022, 151 patients ... were screened'). No registration date given. No blinding check.", "decided_by": "third reader" }, { "trial": "T030", "source": "fulltext", "arms": { "Group S (esketamine)": { "randomized": "105", "analysed": "102" }, "Group L (saline)": { "randomized": "105", "analysed": "100" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "count", "definition": "EPDS ≥ 9", "location": "Table 2, Pre-partum day 1", "values": { "Group S (esketamine)": { "events": "26", "n": "102" }, "Group L (saline)": { "events": "31", "n": "100" } } }, { "measure": "EPDS", "day": 7, "form": "count", "definition": "EPDS ≥ 9", "location": "Table 2, Post-partum week 1", "values": { "Group S (esketamine)": { "events": "4", "n": "102" }, "Group L (saline)": { "events": "2", "n": "100" } } }, { "measure": "EPDS", "day": 14, "form": "count", "definition": "EPDS ≥ 9", "location": "Table 2, Post-partum week 2", "values": { "Group S (esketamine)": { "events": "2", "n": "102" }, "Group L (saline)": { "events": "1", "n": "100" } } }, { "measure": "EPDS", "day": 28, "form": "count", "definition": "EPDS ≥ 9", "location": "Table 2, Post-partum week 4", "values": { "Group S (esketamine)": { "events": "2", "n": "102" }, "Group L (saline)": { "events": "1", "n": "100" } } } ], "pain": [], "adverse_events": [ { "window": "intraoperative", "location": "Table 3, 5 min after administration", "values": { "Group S (esketamine)": { "dizziness": "50", "hallucination": "28", "visual": "0" }, "Group L (saline)": { "dizziness": "4", "hallucination": "0", "visual": "0" } } }, { "window": "intraoperative", "location": "Table 3, 15 min after administration", "values": { "Group S (esketamine)": { "dizziness": "66", "hallucination": "2" }, "Group L (saline)": { "dizziness": "2", "hallucination": "0" } } }, { "window": "emergence", "location": "Table 3, When leaving the operating room", "values": { "Group S (esketamine)": { "dizziness": "34", "hallucination": "0", "visual": "1" }, "Group L (saline)": { "dizziness": "0", "hallucination": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR2100054332", "date": null }, "note": "Depression entries are Table 2 counts of post-partum depression (PPD), defined as an EPDS score of nine or more, evaluated by psychiatrists; 'Pre-partum day 1' is the bedside questionnaire 1 day before delivery (day -1), and weeks 1, 2 and 4 were telephone interviews. Three (S) and five (L) were lost to follow-up and excluded, so all counts use the analysed 102 and 100 (Table 2 header). Continuous EPDS scores are only in Fig. 3, and NRS at rest and when coughing (4, 8, 24, 48 h) only in Fig. 2, with no printed values (text: cough NRS lower in Group S at 24 h, p = 0.016), so no pain entries. Adverse events (Table 3) at 5 and 15 min after esketamine (given 5 min after delivery, under spinal anaesthesia; both coded intraoperative, as separate entries because the overlap between the two times is unknown) and 'when leaving the operating room' (coded emergence). Table 3 prints diplopia and blurred vision as separate rows: Diplopia S 0 / 2 / 0, L 0 / 0 / 0; Blurred vision S 0 / 1 / 1, L 0 / 0 / 0 (5 min / 15 min / leaving the room). visual is 0 in both arms at 5 min (both rows 0) and S 1, L 0 when leaving the room (no diplopia, so the one blurred-vision case is the only visual case); at 15 min visual is left out for both arms because Group S's 2 diplopia and 1 blurred vision cases may overlap (2 or 3 participants). Nausea, headache and vomiting are also in Table 3 (not coded). Enrollment period not stated.", "decided_by": "third reader" }, { "trial": "T031", "source": "fulltext", "arms": { "Ketamine group": { "randomized": "33", "analysed": "32" }, "Placebo group": { "randomized": "33", "analysed": "32" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 1, 'Depression score (point)'", "values": { "Ketamine group": { "median": "12", "q1": "10", "q3": "13", "n": "32" }, "Placebo group": { "median": "11", "q1": "10", "q3": "12", "n": "32" } } }, { "measure": "EPDS", "day": 2, "form": "median_iqr", "location": "Table 3, 'Depression score at 48 h (point)'", "values": { "Ketamine group": { "median": "9", "q1": "6", "q3": "13", "n": "32" }, "Placebo group": { "median": "8", "q1": "6", "q3": "10", "n": "32" } } }, { "measure": "EPDS", "day": 2, "form": "change_median_iqr", "location": "Table 3, exploratory analysis, 'Change from baseline depression score (point): At 48 h'", "values": { "Ketamine group": { "median": "-4", "q1": "-5", "q3": "0", "n": "32" }, "Placebo group": { "median": "-2", "q1": "-4", "q3": "-1", "n": "32" } } }, { "measure": "EPDS", "day": 42, "form": "median_iqr", "location": "Table 3, 'Depression score at 42 days (point)'", "values": { "Ketamine group": { "median": "10", "q1": "7", "q3": "12", "n": "32" }, "Placebo group": { "median": "9", "q1": "7", "q3": "11", "n": "32" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "EPDS ≥ 10", "location": "Table 3, 'Depression score ≥10 at 42 days'", "values": { "Ketamine group": { "events": "18", "n": "32" }, "Placebo group": { "events": "14", "n": "32" } } }, { "measure": "EPDS", "day": 42, "form": "change_median_iqr", "location": "Table 3, exploratory analysis, 'Change from baseline depression score (point): At 42 days'", "values": { "Ketamine group": { "median": "-2", "q1": "-4", "q3": "0", "n": "32" }, "Placebo group": { "median": "-2", "q1": "-5", "q3": "-1", "n": "32" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Table 3, 'Numeric rating scale of pain at rest: At 24 h'", "values": { "Ketamine group": { "median": "4", "q1": "3", "q3": "5", "n": "32" }, "Placebo group": { "median": "4", "q1": "3", "q3": "4", "n": "32" } } } ], "adverse_events": [ { "window": "intraoperative", "location": "Table 5, Intraoperative period", "values": { "Ketamine group": { "hallucination": "1", "dizziness": "5", "visual": "3" }, "Placebo group": { "hallucination": "0", "dizziness": "3", "visual": "0" } } }, { "window": "postoperative", "location": "Table 5, Postoperative period", "values": { "Ketamine group": { "nightmare": "0" }, "Placebo group": { "nightmare": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2017-11-23", "end": "2018-05-14" }, "registration": { "number": "NCT03336541", "date": "08/11/2017" }, "note": "66 randomized (33/33); one per arm withdrew consent, so efficacy analyses (ITT and per-protocol) have 32/32 and the safety analysis (Table 5) 33/33. EPDS baseline was taken the day before surgery (Table 1, median (IQR)). Table 3 footnote says 'mean ± SD, n (%) or median (interquartile range)'; the text confirms depression scores are median (IQR). Table 3 also prints Hodges-Lehmann median differences (48 h: 1 (-1, 3); 42 days: 1 (-1, 2)) and RR 1.29 (0.78, 2.12) for EPDS ≥10, not recorded since arm values are given; Table 4 gives regression results. Minus signs printed as U+2212 are recorded as '-'. Pain: NRS at rest at 4 h, 8 h and 42 days left out (outside the day 1/day 2 windows). Adverse events from Table 5: 'Diplopia' coded as visual. Table 5 also prints a composite 'Dissociative symptoms' 10 (30.3%) vs 3 (9.1%), which the text defines as hallucination, dizziness, diplopia and hypertonia, so it is not coded as dissociation; hypertonia 1 vs 0, somnolence 4 vs 0 and sedation 5 vs 0 not coded. Enrollment is the Results' eligibility-assessment window; last follow-up June 25, 2018. Registration date printed '08/11/2017' (format not stated; the ethics approval date is printed the same way).", "decided_by": "third reader" }, { "trial": "T032", "source": "fulltext", "arms": { "Esketamine": { "randomized": "92", "analysed": "92" }, "Saline": { "randomized": "91", "analysed": "91" } }, "depression": [ { "measure": "HADS depression subscale (HADS-D)", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Esketamine": { "median": "3", "q1": "2", "q3": "4", "n": "92" }, "Saline": { "median": "3", "q1": "2", "q3": "4", "n": "91" } } }, { "measure": "HADS depression subscale (HADS-D)", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine": { "median": "2", "q1": "2", "q3": "3", "n": "92" }, "Saline": { "median": "2", "q1": "2", "q3": "3", "n": "91" } } }, { "measure": "HADS depression subscale (HADS-D)", "day": 3, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine": { "median": "2", "q1": "2", "q3": "3", "n": "92" }, "Saline": { "median": "2", "q1": "2", "q3": "2", "n": "91" } } } ], "pain": [ { "measure": "VAS on movement", "day": 1, "form": "median_iqr", "location": "Results, pain paragraph", "values": { "Esketamine": { "median": "3", "q1": "3", "q3": "4" }, "Saline": { "median": "4", "q1": "3", "q3": "5" } } }, { "measure": "VAS on movement", "day": 2, "form": "median_iqr", "location": "Results, pain paragraph", "values": { "Esketamine": { "median": "2", "q1": "2", "q3": "3" }, "Saline": { "median": "3", "q1": "2", "q3": "3" } } }, { "measure": "hydromorphone consumption at 24 and 48 h", "day": 1, "form": "median_iqr", "location": "Results, pain paragraph", "values": { "Esketamine": { "median": "3.0", "q1": "2.8", "q3": "3.3" }, "Saline": { "median": "3.2", "q1": "2.9", "q3": "3.4" } } }, { "measure": "hydromorphone consumption at 24 and 48 h", "day": 2, "form": "median_iqr", "location": "Results, pain paragraph", "values": { "Esketamine": { "median": "5.9", "q1": "5.5", "q3": "6.5" }, "Saline": { "median": "6.1", "q1": "5.7", "q3": "6.7" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2021-08", "end": "2022-04" }, "registration": null, "note": "Results say '183 patients were randomized into 2 groups: control group (n = 91 ...) and esketamine group (n = 92 ...)' after 200 were assessed and 16 excluded, and that 1 control patient's data were lost on POD3, with the analysis per protocol 'because there was 1 incomplete piece of information'; whether the control group's 91 is counted before or after that loss is unclear. Tables 1 and 2 headers give 91 (control) and 92 (esketamine). Baseline HADS-D was taken on preoperative day 1. Pain values are from the Results text, esketamine named first, n not printed; hydromorphone (mg) day 2 is the cumulative total over 0 to 48 h. VAS at rest at 24 and 48 h reported only as not different (eTable 2, not available). AEs (nausea and vomiting, dizziness, itching, nightmare) are in eTable 3, not available; the text says only that 1 patient reported a nightmare, without naming the arm, so nothing coded. Enrollment dates from Methods (surgery from August 2021 to April 2022); the Results give none. No registration number in the text.", "decided_by": "both coders" }, { "trial": "T033", "source": "fulltext", "arms": { "Group L (low dose)": { "randomized": null, "analysed": "38" }, "Group M (middle dose)": { "randomized": null, "analysed": "40" }, "Group H (high dose)": { "randomized": null, "analysed": "39" }, "Group C (control)": { "randomized": null, "analysed": "39" } }, "depression": [ { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "day": 7, "form": "count", "definition": "PPD by EPDS (cutoff not stated)", "location": "Table 3, 'Occurrence of PPD: 1 week'", "values": { "Group L (low dose)": { "events": "5", "n": "38" }, "Group M (middle dose)": { "events": "0", "n": "40" }, "Group H (high dose)": { "events": "0", "n": "39" }, "Group C (control)": { "events": "12", "n": "39" } } }, { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "day": 42, "form": "count", "definition": "PPD by EPDS (cutoff not stated)", "location": "Table 3, 'Occurrence of PPD: 6 weeks'", "values": { "Group L (low dose)": { "events": "7", "n": "38" }, "Group M (middle dose)": { "events": "2", "n": "40" }, "Group H (high dose)": { "events": "1", "n": "39" }, "Group C (control)": { "events": "14", "n": "39" } } } ], "pain": [ { "measure": "effective PCIA presses within 48 h", "day": 2, "form": "mean_sd", "location": "Table 2, 'Effective press (times)'", "values": { "Group L (low dose)": { "mean": "4.1", "sd": "0.8", "n": "38" }, "Group M (middle dose)": { "mean": "2.9", "sd": "0.7", "n": "40" }, "Group H (high dose)": { "mean": "1.6", "sd": "0.6", "n": "39" }, "Group C (control)": { "mean": "5.4", "sd": "1.0", "n": "39" } } }, { "measure": "total sufentanil consumption within 48 h", "day": 2, "form": "mean_sd", "location": "Table 2, 'Consumption of sufentanil (μg)'", "values": { "Group L (low dose)": { "mean": "66.8", "sd": "5.1", "n": "38" }, "Group M (middle dose)": { "mean": "63.4", "sd": "3.8", "n": "40" }, "Group H (high dose)": { "mean": "60.6", "sd": "1.2", "n": "39" }, "Group C (control)": { "mean": "72.0", "sd": "4.4", "n": "39" } } }, { "measure": "rescue tramadol within 48 h", "day": 2, "form": "count", "definition": "rescue analgesia (tramadol 50 mg i.v.) within 48 h", "location": "Table 2, 'Rescue analgesia [n (%)]'", "values": { "Group L (low dose)": { "events": "2", "n": "38" }, "Group M (middle dose)": { "events": "2", "n": "40" }, "Group H (high dose)": { "events": "1", "n": "39" }, "Group C (control)": { "events": "9", "n": "39" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Group L (low dose)": { "nightmare": "0", "visual": "0" }, "Group M (middle dose)": { "nightmare": "0", "visual": "0" }, "Group H (high dose)": { "nightmare": "0", "visual": "0" }, "Group C (control)": { "nightmare": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-05-02", "end": "2021-12-31" }, "registration": { "number": "ChiCTR2200060387", "date": "April 7, 2021" }, "note": "Per-arm randomized numbers are not printed: 160 enrolled and randomized to 4 groups (Methods also says 'Sixty samples for each group were designed'); 4 excluded after randomization (1 in C, 2 in L, 1 in H), 156 analysed, with analysed n from Table 1-3 row labels. PPD at 1 and 6 weeks is by EPDS with no cutoff stated. Group C's 1-week PPD is printed '12 (30.1)', which does not match 12/39; events copied as printed. Table 2 values are mean ± SD (effective presses, sufentanil μg) and n (%) (rescue analgesia), all within 48 h after surgery. Adverse events (Table 3) were recorded within 48 hours after surgery; nightmares and diplopia (coded as visual) were 0 (0) in all four groups. Enrollment period is from Methods 2.4 (Results do not state it). Registration printed as 'ChiCTR2200060387 on April 7, 2021'; the ID's '22' prefix is the form ChiCTR uses for 2022 registrations, so the date may be an error.", "decided_by": "both coders" }, { "trial": "T034", "source": "fulltext", "arms": { "SC group": { "randomized": "8", "analysed": "8" }, "IV group": { "randomized": "8", "analysed": "8" }, "Placebo group": { "randomized": "7", "analysed": "7" } }, "depression": [ { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "day": -1, "form": "mean_sd", "location": "Table 1, 'Pre-operative screening: Depression (EPDS)'", "values": { "SC group": { "mean": "6.25", "sd": "6.27", "n": "8" }, "IV group": { "mean": "5", "sd": "4.78", "n": "8" }, "Placebo group": { "mean": "8.29", "sd": "4.72", "n": "7" } } } ], "pain": [ { "measure": "opioid consumption first 48 h (oral MME)", "day": 2, "form": "mean_sd", "location": "Results, 'Postpartum mood, surgical site pain, opioid consumption' paragraph", "values": { "SC group": { "mean": "68.4", "sd": null, "n": null }, "IV group": { "mean": "67.0", "sd": null, "n": null }, "Placebo group": { "mean": "88.6", "sd": null, "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "values": { "SC group": { "hallucination": "0", "visual": "1", "dizziness": "1", "any_ae": "6" }, "IV group": { "hallucination": "0", "visual": "3", "dizziness": "3", "any_ae": "6" }, "Placebo group": { "hallucination": "0", "visual": "1", "dizziness": "1", "any_ae": "7" } } } ], "blinding_check": null, "enrollment": { "start": "2020-12", "end": "2021-08" }, "registration": { "number": "NCT04227704", "date": "14/01/2020" }, "note": "25 consented, 2 withdrawn before the intervention; 'Eight women were allocated to each of the intervention groups while seven women were allocated to placebo control' (recorded as randomized; Fig. 1 not reproduced). Analysed is the n of Tables 1 and 2; full 6-week depression data were obtained for 18/23 overall, not given by arm. Post-delivery EPDS (days 1, 2, 21, 42) and surgical site pain NRS are shown only as graphs (Fig. 2), so not extracted; 8 women (34.8%) screened positive (EPDS > 12) at least once postpartum, cohort-wide only. Baseline EPDS is the pre-operative screening on the day of surgery, mean (SD). Opioid consumption: text gives only mean MME for the first 48 h, no SD or n. Adverse effects (Table 2) are graded mild/moderate/severe; for dizziness and blurred vision only the 'Mild' row is non-zero (moderate and severe 0 (0)), so the mild counts are recorded. 'visual' is the blurred vision row; diplopia is a separate row (mild 0/1/1, others 0) and nystagmus is 0 in all arms, overlap unknown. Hallucination is from the combined row 'Euphoria, Amnesia, Hallucinations, Nystagmus' 0 (0) in every arm. any_ae is 'Self-reported AE incidence'; hemodynamic AE incidence (3/3/2) is separate. Window is not labelled in Table 2; coded intraoperative because its rows match the Methods' list of intraoperative adverse effects and the text calls the shivering difference intraoperative. Anxiety (mild 0/1/2, moderate 0/0/1) not coded. Enrollment period is from Methods (Results do not state it).", "decided_by": "both coders" }, { "trial": "T035", "source": "library", "arms": { "S-ketamine group": { "randomized": "40", "analysed": "39" }, "Saline group": { "randomized": "40", "analysed": "38" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "S-ketamine group": { "median": "5", "q1": "4", "q3": "7", "n": "39" }, "Saline group": { "median": "6", "q1": "4", "q3": "7.8", "n": "38" } } }, { "measure": "HADS-D", "day": 2, "form": "median_iqr", "location": "Table 4", "values": { "S-ketamine group": { "median": "4.0", "q1": "3.0", "q3": "6.0", "n": "39" }, "Saline group": { "median": "6.0", "q1": "5.0", "q3": "8.0", "n": "38" } } }, { "measure": "HADS-D", "day": 2, "form": "count", "location": "Table 4", "definition": "HADS-D score >7", "values": { "S-ketamine group": { "events": "6", "n": "39" }, "Saline group": { "events": "5", "n": "38" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "mean_sd", "location": "Results, Secondary Outcomes text", "values": { "S-ketamine group": { "mean": "2.5", "sd": "0.51", "n": null }, "Saline group": { "mean": "2.8", "sd": "0.66", "n": null } } }, { "measure": "NRS at rest", "day": 2, "form": "mean_sd", "location": "Results, Secondary Outcomes text", "values": { "S-ketamine group": { "mean": "2.1", "sd": "0.61", "n": null }, "Saline group": { "mean": "2.6", "sd": "0.76", "n": null } } }, { "measure": "NRS when coughing", "day": 1, "form": "mean_sd", "location": "Results, Secondary Outcomes text", "values": { "S-ketamine group": { "mean": "3.6", "sd": "0.59", "n": null }, "Saline group": { "mean": "4.3", "sd": "0.64", "n": null } } }, { "measure": "NRS when coughing", "day": 2, "form": "mean_sd", "location": "Results, Secondary Outcomes text", "values": { "S-ketamine group": { "mean": "3.3", "sd": "0.57", "n": null }, "Saline group": { "mean": "3.7", "sd": "0.69", "n": null } } }, { "measure": "rescue analgesia requirement (IM bucinnazine)", "day": 2, "form": "count", "location": "Table 4", "definition": "patients given rescue analgesia within the 48 h study period", "values": { "S-ketamine group": { "events": "9", "n": "39" }, "Saline group": { "events": "17", "n": "38" } } }, { "measure": "rescue analgesia requirement (IM bucinnazine)", "day": 2, "form": "median_iqr", "location": "Table 4", "values": { "S-ketamine group": { "median": "0.0", "q1": "0.0", "q3": "75.0", "n": "39" }, "Saline group": { "median": "0.0", "q1": "0.0", "q3": "100.0", "n": "38" } } } ], "adverse_events": [ { "window": "overall", "location": "Results, Secondary Outcomes text; Discussion", "values": { "S-ketamine group": { "visual": "1", "hallucination": "0", "dissociation": "0", "dizziness": "0", "nightmare": "0" }, "Saline group": { "visual": "0", "hallucination": "0", "dissociation": "0", "dizziness": "0", "nightmare": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-05", "end": "2021-12" }, "registration": { "number": "ChiCTR2100046552", "date": null }, "note": "Library copy of the PDF ('§' is the extraction's rendering of '±'). Randomized 40 per arm from Statistical Analysis ('the authors enrolled 40 patients per group'; 80 enrolled, allocated 1:1); three were excluded after allocation, arms not stated; analysed 39 and 38 from the table headers. HADS-D at 48 h from Table 4; the text prints the same values without decimals (4 [3-6] v 6 [5-8]), Table 4's taken. Depression count: HADS-D score >7 (Table 4 footnote). NRS at 24 and 48 h from the Results text, which says 'mean NRS scores' and lists the S-ketamine value first (the values agree with 'lower in the S-ketamine group'); Figure 2 plots them with 95% CI error bars and prints no n, so n is null. The abstract gives p = 0.006 at 48 h rest where the text gives 0.005. Rescue analgesia: the count is patients given rescue analgesia, the median_iqr is bucinnazine mg, both within the first 48 h (text 0 [0-75] v 0 [0-100]; Table 4's decimals taken). Adverse events: Methods prespecify illusions, dissociation, diplopia, nystagmus, dizziness, dreams and urinary retention; the Results say 'Only 1 patient experienced an S-ketamine-related adverse event during the study' and the Discussion '1 case of diplopia that was self-limiting in the S-ketamine group'; the zeros come from those statements, not printed numerals (illusions coded as hallucination, dreams as nightmare). PONV 11 (28.2) vs 15 (39.5) not coded. The QoR-40 pain dimension is a recovery subscale and is not entered. Enrollment from the Results ('Between May 2021 and December 2021'). No registration date given. No blinding check.", "decided_by": "third reader" }, { "trial": "T036", "source": "fulltext", "arms": { "K1 group": { "randomized": "26", "analysed": "26" }, "K2 group": { "randomized": "26", "analysed": "26" }, "K3 group": { "randomized": "26", "analysed": "26" }, "C group": { "randomized": "26", "analysed": "26" } }, "depression": [ { "measure": "HADS depression subscale (HAD-D)", "day": -1, "form": "mean_sd", "location": "Table 2", "values": { "K1 group": { "mean": "7.4", "sd": "3.2", "n": "26" }, "K2 group": { "mean": "7.4", "sd": "4.9", "n": "26" }, "K3 group": { "mean": "7.4", "sd": "3.7", "n": "26" }, "C group": { "mean": "7.4", "sd": "4.0", "n": "26" } } }, { "measure": "HADS depression subscale (HAD-D)", "day": 1, "form": "mean_sd", "location": "Table 2", "values": { "K1 group": { "mean": "10.2", "sd": "4.3", "n": "26" }, "K2 group": { "mean": "10.2", "sd": "5.0", "n": "26" }, "K3 group": { "mean": "6.5", "sd": "4.1", "n": "26" }, "C group": { "mean": "11.2", "sd": "3.7", "n": "26" } } }, { "measure": "HADS depression subscale (HAD-D)", "day": 2, "form": "mean_sd", "location": "Table 2", "values": { "K1 group": { "mean": "10.3", "sd": "4.8", "n": "26" }, "K2 group": { "mean": "10.3", "sd": "5.2", "n": "26" }, "K3 group": { "mean": "5.7", "sd": "3.9", "n": "26" }, "C group": { "mean": "10.8", "sd": "3.7", "n": "26" } } }, { "measure": "HADS depression subscale (HAD-D)", "day": 3, "form": "mean_sd", "location": "Table 2", "values": { "K1 group": { "mean": "9.8", "sd": "4.7", "n": "26" }, "K2 group": { "mean": "9.9", "sd": "5.4", "n": "26" }, "K3 group": { "mean": "4.5", "sd": "3.3", "n": "26" }, "C group": { "mean": "10.1", "sd": "3.8", "n": "26" } } } ], "pain": [], "adverse_events": [ { "window": "emergence", "location": "Table 6 (30 min after extubation); Results, Safety Analysis text", "values": { "K1 group": { "agitation": "3", "dizziness": "0", "visual": "0" }, "K2 group": { "agitation": "3", "dizziness": "0", "visual": "0" }, "K3 group": { "agitation": "2", "dizziness": "0", "visual": "0" }, "C group": { "agitation": "1", "dizziness": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2015-01", "end": "2017-10" }, "registration": null, "note": "Tables call the control arm 'Control group' (= C group). 26 per group randomized and analysed. HAD-D 'Time_0 h' is the preoperative baseline (text: 'before operation'; all 7.4), so day -1; 24, 48 and 72 h are days 1, 2, 3. VAS only 30 min after extubation, so no pain entries. Adverse events at 30 min after extubation (Table 6): the 'Dysphoria' row is coded as agitation because the text calls it emergence agitation. Not coded: delirium at 30 min (K1 2, K2 1, K3 1, C 0; all 0 at the second assessment) and dysphoria at leaving the operating/recovery room (2, 2, 1, 1). Dizziness and visual zeros are from the text ('No dizziness, nausea, vomiting, diplopia, or other adverse reactions were found 30 min after extubation'), not printed. Hallucination, which the Methods list among recorded events, is not coded: that sentence doesn't name it, and its catch-all 'other adverse reactions' is contradicted by Table 6 ('Disgusting', apparently nausea, 1 (3.8) in K1 and control), so no hallucination count is reported. Enrollment dates from Methods. No registration given.", "decided_by": "third reader" }, { "trial": "T037", "source": "registry", "arms": { "Low-Dose Ketamine (LDK) Treatment Group": { "randomized": "1", "analysed": "0" }, "Control Group": { "randomized": "0", "analysed": "0" } }, "depression": [], "pain": [], "adverse_events": [ { "window": "overall", "time": "registry adverse-event time frame: 1 day", "location": "Adverse events (1 day)", "values": { "Low-Dose Ketamine (LDK) Treatment Group": { "any_ae": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT05229653", "date": null }, "note": "ClinicalTrials.gov posted results. Participant flow: STARTED 1 (LDK) and 0 (Control); COMPLETED 0 and 0; NOT COMPLETED 1 and 0; randomized records the STARTED counts. Every outcome (pelvic pain VAS, GAD-7 and MADRS at baseline and POD 1, 27, 55 and 83; EHP-30; change in opioid use) lists Analysed 0 in both arms and no values, so there are no depression or pain entries. Adverse events (time frame 1 day): LDK serious 0/1, other 0/1; Control serious 0/0, other 0/0. The registry's serious and other (non-serious) tables together hold every adverse event, and with one participant at risk no event could fall under a reporting threshold, so any_ae '0' for LDK is the registry's printed zero; the control arm had no one at risk and has no adverse-event values. No enrollment dates or registration date are given.", "decided_by": "third reader" }, { "trial": "T038", "source": "registry", "arms": { "Ketamine Group": { "randomized": "1", "analysed": "1" }, "Placebo Group": { "randomized": "0", "analysed": "0" } }, "depression": [ { "measure": "PROMIS Emotional Distress-Depression Short Form", "day": -1, "form": "mean_sd", "location": "Posted results, secondary outcome 'Pre-surgical Emotional Distress Related to Depression' (Screening visit)", "values": { "Ketamine Group": { "mean": "27", "sd": "0", "n": "1" }, "Placebo Group": { "n": "0" } } }, { "measure": "PROMIS Emotional Distress-Depression Short Form", "day": 10, "form": "mean_sd", "location": "Posted results, secondary outcome 'Post-surgical Emotional Distress Related to Depression' (Day 10-14 Post-Operative Visit)", "values": { "Ketamine Group": { "mean": "14", "sd": "0", "n": "1" }, "Placebo Group": { "n": "0" } } }, { "measure": "PROMIS Emotional Distress-Depression Short Form", "day": 42, "form": "mean_sd", "location": "Posted results, secondary outcome 'Post-surgical Emotional Distress Related to Depression' (6-week follow-up visit)", "values": { "Ketamine Group": { "mean": "19", "sd": "0", "n": "1" }, "Placebo Group": { "n": "0" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "location": "Posted results, adverse events (collected from signed consent to 6 weeks)", "values": { "Ketamine Group": { "any_ae": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT04220489", "date": null }, "note": "Only one participant enrolled, in the Ketamine Group; the Placebo Group started with 0 (participant flow), so there is no comparison. The registry's 'spread=0' is copied as sd '0' (single participant). Day 10 is the registry's 'Day 10-14 Post-Operative Visit', the average of scores collected POD 10-14. Pain outcomes are only 72-hour summaries (hydromorphone PCA and medical-record opioid use, each 40 mg morphine equivalents per 24 h; VAS 5 averaged over 72 h), so none falls at day 1 or 2; the Pain Catastrophizing Scale had 0 analysed; the cold-pressor test was reported only at screening (19.49, spread 0.98 s). any_ae '0' reads the registry's serious 0/1 and other 0/1 for the Ketamine Group; the Placebo Group's 0/0 had no one at risk and is left out. The registry gives no enrollment dates.", "decided_by": "both coders" }, { "trial": "T039", "source": "fulltext", "arms": { "Experimental Group A: labor analgesia with esketamine": { "randomized": null, "analysed": "100" }, "Experimental Group B: labor analgesia alone": { "randomized": null, "analysed": "100" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 42, "form": "count", "definition": "EPDS score ≥ 10 ('incidence of depression ... in the postpartum period')", "location": "Results, Comparison of EPDS and VAS scores among the groups (text, citing Supplementary Table S2)", "values": { "Experimental Group A: labor analgesia with esketamine": { "events": "4", "n": "100" }, "Experimental Group B: labor analgesia alone": { "events": "2", "n": "100" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "values": { "Experimental Group A: labor analgesia with esketamine": { "dizziness": "12.0%" }, "Experimental Group B: labor analgesia alone": { "dizziness": "2.0%" } } } ], "blinding_check": null, "enrollment": { "start": "2020-02", "end": "2022-01" }, "registration": { "number": "ChiCTR2500104037", "date": null }, "note": "Group C (no labor analgesia, role other) is not coded (depression 6/99, 6.1%; dizziness 0.0%). 312 women were enrolled and randomized in total; 13 converted to caesarean were excluded, leaving 100, 100 and 99 analysed; per-arm randomized numbers are only in Supplementary Figure S1. TIME AMBIGUOUS: the depression count is the 'incidence of depression (defined as EPDS score ≥ 10) in the postpartum period' (4.0% (4/100) vs 2.0% (2/100), p = 0.223 across three groups) with no time point stated; coded as day 42, the last postpartum assessment, but it may count any postpartum assessment (days 1, 7, 42). EPDS scores (prenatal, postpartum day 1, 7, 42) and VAS pain (2 h, day 1, 2, 7) are shown only in bar graphs (Figures 1 and 4) without printed values. Dizziness is printed only as percentages of each group (Group A 12.0%, Group B 2.0%), copied as printed; safety was monitored from the start of analgesia until 2 h postpartum (window coded overall). Hallucinations/dissociative symptoms, nausea and vomiting are reported only as not significantly different (Supplementary Table S3). Open-label trial with outcome assessors not involved in intrapartum care. Enrollment dates from Results. Registered retrospectively; no registration date given.", "decided_by": "both coders" }, { "trial": "T040", "source": "fulltext", "arms": { "Ketamine group": { "randomized": "20", "analysed": "20" }, "Placebo (saline) group": { "randomized": "20", "analysed": "20" } }, "depression": [ { "measure": "MADRS", "day": -1, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 0 (pre-infusion)'", "values": { "Ketamine group": { "mean": "25.1", "sd": "8.3", "n": "20" }, "Placebo (saline) group": { "mean": "29.9", "sd": "7.0", "n": "19" } } }, { "measure": "MADRS", "day": 1, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 1'", "values": { "Ketamine group": { "mean": "12.7", "sd": "7.6", "n": "20" }, "Placebo (saline) group": { "mean": "16.4", "sd": "10.0", "n": "19" } } }, { "measure": "MADRS", "day": 1, "form": "change_mean_sd", "location": "Results, Outcomes, second paragraph (change from day 0 to day 1)", "values": { "Ketamine group": { "mean": "-12.4", "sd": "9.2", "n": null }, "Placebo (saline) group": { "mean": "-14.7", "sd": "9.0", "n": null } } }, { "measure": "MADRS", "day": 2, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 2'", "values": { "Ketamine group": { "mean": "15.1", "sd": "11.1", "n": "19" }, "Placebo (saline) group": { "mean": "17.5", "sd": "11.5", "n": "20" } } }, { "measure": "MADRS", "day": 3, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 3'", "values": { "Ketamine group": { "mean": "17.0", "sd": "10.5", "n": "19" }, "Placebo (saline) group": { "mean": "17.2", "sd": "12.0", "n": "20" } } }, { "measure": "MADRS", "day": 5, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 5'", "values": { "Ketamine group": { "mean": "16.9", "sd": "8.0", "n": "19" }, "Placebo (saline) group": { "mean": "16.9", "sd": "10.1", "n": "18" } } }, { "measure": "MADRS", "day": 7, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 7'", "values": { "Ketamine group": { "mean": "15.9", "sd": "9.2", "n": "18" }, "Placebo (saline) group": { "mean": "18.5", "sd": "10.8", "n": "19" } } }, { "measure": "MADRS", "day": 14, "form": "mean_sd", "location": "Extended Data Table 1, 'Day 14'", "values": { "Ketamine group": { "mean": "16.9", "sd": "10.0", "n": "19" }, "Placebo (saline) group": { "mean": "16.2", "sd": "12.5", "n": "19" } } }, { "measure": "HADS score", "day": -1, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 0 (pre-infusion)'", "values": { "Ketamine group": { "mean": "22.9", "sd": "4.2", "n": "20" }, "Placebo (saline) group": { "mean": "24.6", "sd": "5.6", "n": "19" } } }, { "measure": "HADS score", "day": 1, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 1'", "values": { "Ketamine group": { "mean": "17.8", "sd": "6.6", "n": "20" }, "Placebo (saline) group": { "mean": "19.9", "sd": "5.5", "n": "19" } } }, { "measure": "HADS score", "day": 2, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 2'", "values": { "Ketamine group": { "mean": "18.8", "sd": "7.5", "n": "18" }, "Placebo (saline) group": { "mean": "21.2", "sd": "5.9", "n": "20" } } }, { "measure": "HADS score", "day": 3, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 3'", "values": { "Ketamine group": { "mean": "19.3", "sd": "6.3", "n": "19" }, "Placebo (saline) group": { "mean": "20.8", "sd": "5.4", "n": "20" } } }, { "measure": "HADS score", "day": 5, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 5'", "values": { "Ketamine group": { "mean": "18.3", "sd": "4.8", "n": "19" }, "Placebo (saline) group": { "mean": "18.9", "sd": "7.3", "n": "19" } } }, { "measure": "HADS score", "day": 7, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 7'", "values": { "Ketamine group": { "mean": "18.4", "sd": "5.3", "n": "16" }, "Placebo (saline) group": { "mean": "19.6", "sd": "8.1", "n": "19" } } }, { "measure": "HADS score", "day": 14, "form": "mean_sd", "location": "Extended Data Table 1, 'HADS total score: Day 14'", "values": { "Ketamine group": { "mean": "16.4", "sd": "7.2", "n": "19" }, "Placebo (saline) group": { "mean": "17.2", "sd": "8.5", "n": "19" } } } ], "pain": [ { "measure": "cumulative and daily opioid use (MME)", "day": 1, "form": "mean_sd", "location": "Extended Data Table 2, 'Average Daily Inpatient Opioid Use, in MME: Day 1'", "values": { "Ketamine group": { "mean": "81.6", "sd": "59.6", "n": "14" }, "Placebo (saline) group": { "mean": "69.2", "sd": "62.2", "n": "16" } } }, { "measure": "cumulative and daily opioid use (MME)", "day": 2, "form": "mean_sd", "location": "Extended Data Table 2, 'Average Daily Inpatient Opioid Use, in MME: Day 2'", "values": { "Ketamine group": { "mean": "83.3", "sd": "65.2", "n": "8" }, "Placebo (saline) group": { "mean": "77.6", "sd": "71.3", "n": "13" } } } ], "adverse_events": [], "blinding_check": { "who": "participants", "day": 14, "values": null, "overall": { "correct": "36.8%", "kappa": "0.33", "n_per_arm": "19", "guessed_ketamine": "16", "guessed_placebo": "10", "dont_know": "12" }, "location": "Results, Outcomes (text after the MADRS change scores); by-arm guesses only as percentages in Figure 2B (graph, n=19 per group, no printed values); Extended Data Figure 1 caption gives guess groups n=17/10/11" }, "enrollment": { "start": "2020-02-19", "end": "2022-08-18" }, "registration": null, "note": "40 randomized (20/20, after 5 open-label pilot patients not reported); ITT analysis of the primary outcome with n=20 per arm. Day -1 is the Day 0 pre-infusion assessment on the morning of surgery (Extended Data Table 1), the baseline nearest the procedure and the one the text's change scores start from. The screening visit, a mean of 5.1 days before surgery, is not entered as a second day -1 entry: Table 1, n=20 per arm, MADRS 27.7±7.8 vs 30.6±6.3, HADS total 24.6±6.0 vs 24.7±5.7. Post-infusion days equal postoperative days (infusion given during surgery). The day 1 change from day 0 (-12.4 SD 9.2 vs -14.7 SD 9.0) is from the text, no n given. Minus signs printed as U+2212 are recorded as '-'. Table 1's screening HADS depression subscore (12.0±3.2 vs 10.5±3.6) and PHQ-8 total (15.8±3.6 vs 15.8±3.8) are not design measures and are not entered; neither is the HADS anxiety subscore. Extended Data Table 1 also gives clinical response (>=50% MADRS reduction from screening) and remission (MADRS <=12) as n/N by day (e.g. remission day 1: 10/20 vs 7/20); not entered, since they count improved participants, not participants with depression, and the MADRS means are given at every time. Table 3 gives mixed-model estimates only. Pain: BPI-SF is reported only at screening and day 14 (average pain 4.8 SD 1.5 vs 3.7 SD 2.0), outside day 1/2. Opioid use day 1/2 is average daily inpatient MME among patients hospitalised the whole day; cumulative opioid consumption is only in Figure 2E (median, IQR graph). No psychotomimetic adverse events are reported; one death in the ketamine group 5 days post-infusion (cardiac arrest at home) and one placebo reoperation on day 3. Blinding: guesses by arm are only percentages in Figure 2B; the text gives 36.8% correct overall, kappa 0.33, and guess groups n=16 ketamine / 10 placebo / 12 don't know, while the Extended Data Figure 1 caption gives 17/10/11. No trial registration number appears in the text.", "decided_by": "third reader" }, { "trial": "T041", "source": "fulltext", "arms": { "Group E": { "randomized": "142", "analysed": "108" }, "Group C": { "randomized": "142", "analysed": "101" } }, "depression": [ { "measure": "Hamilton Depression Scale 17 (HAMD-17)", "day": -1, "form": "count", "definition": "HAMD-17 ≥ 7", "location": "Table 3", "values": { "Group E": { "events": "32", "n": "108" }, "Group C": { "events": "37", "n": "101" } } }, { "measure": "Hamilton Depression Scale 17 (HAMD-17)", "day": 3, "form": "count", "definition": "HAMD-17 ≥ 7", "location": "Table 3", "values": { "Group E": { "events": "55", "n": "102" }, "Group C": { "events": "67", "n": "99" } } }, { "measure": "Hamilton Depression Scale 17 (HAMD-17)", "day": 7, "form": "count", "definition": "HAMD-17 ≥ 7", "location": "Table 3", "values": { "Group E": { "events": "26", "n": "99" }, "Group C": { "events": "46", "n": "96" } } }, { "measure": "Hamilton Depression Scale 17 (HAMD-17)", "day": 90, "form": "count", "definition": "HAMD-17 ≥ 7", "location": "Table 3", "values": { "Group E": { "events": "11", "n": "83" }, "Group C": { "events": "25", "n": "88" } } } ], "pain": [ { "measure": "Postoperative exercise NRS score", "day": 1, "form": "mean_sd", "location": "Table 4", "values": { "Group E": { "mean": "2.67", "sd": "0.97", "n": "108" }, "Group C": { "mean": "2.84", "sd": "0.86", "n": "101" } } }, { "measure": "Postoperative exercise NRS score", "day": 2, "form": "mean_sd", "location": "Table 4", "values": { "Group E": { "mean": "2.25", "sd": "1.00", "n": "108" }, "Group C": { "mean": "2.46", "sd": "0.88", "n": "101" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Group E": { "dizziness": "16", "nightmare": "3", "hallucination": "0" }, "Group C": { "dizziness": "10", "nightmare": "1", "hallucination": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2022-08", "end": "2023-08" }, "registration": { "registry": "Chinese Clinical Trial Registry", "number": "ChiCTR2300069249", "date": null }, "note": "Randomized: the Results say 284 signed consent, 142 in each group (the flowchart is not in the text); analysed = the column Ns of Tables 1 and 4 (108, 101) after early withdrawals. HAMD-17 is reported only as counts of depressive symptoms (HAMD-17 ≥ 7) in Table 3, each time with its own denominator; HAMD scores are only plotted (Figure 3, no printed values). Pain: the design lists none; Table 4 reports NRS on movement ('postoperative exercise NRS score', mean (SD)) on postoperative days 1 to 3, coded at days 1 and 2 under the source's name with the table's column Ns; pump presses and dezocine rescue are not pain scores and are left out. Adverse events are Table 5's postoperative in-hospital events. Enrollment is from Methods (study carried out 1 August 2022 to 30 August 2023); the Results give no dates. Registration number given without a date.", "decided_by": "both coders" }, { "trial": "T042", "source": "fulltext", "arms": { "Esketamine group": { "randomized": null, "analysed": "124" }, "Control group": { "randomized": null, "analysed": "122" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "mean_sd", "location": "Table 1 (same values in Results, first paragraph)", "values": { "Esketamine group": { "mean": "3.6", "sd": "3.0", "n": "124" }, "Control group": { "mean": "4.0", "sd": "2.1", "n": "122" } } }, { "measure": "EPDS", "day": 42, "form": "mean_sd", "location": "Results, first paragraph", "values": { "Esketamine group": { "mean": "6.87", "sd": "2.14" }, "Control group": { "mean": "9.02", "sd": "2.21" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "mean_sd", "location": "Results, NRS at rest sentence (24 h pair)", "values": { "Esketamine group": { "mean": "2.86", "sd": "0.58" }, "Control group": { "mean": "3.01", "sd": "0.75" } } }, { "measure": "NRS at rest", "day": 2, "form": "mean_sd", "location": "Results, NRS at rest sentence (48 h pair)", "values": { "Esketamine group": { "mean": "1.91", "sd": "0.62" }, "Control group": { "mean": "2.11", "sd": "0.43" } } }, { "measure": "NRS on movement", "day": 1, "form": "mean_sd", "location": "Results, NRS on movement sentence (24 h pair)", "values": { "Esketamine group": { "mean": "3.39", "sd": "1.57" }, "Control group": { "mean": "4.50", "sd": "0.80" } } }, { "measure": "NRS on movement", "day": 2, "form": "mean_sd", "location": "Results, NRS on movement sentence (48 h pair)", "values": { "Esketamine group": { "mean": "2.43", "sd": "0.87" }, "Control group": { "mean": "3.56", "sd": "0.76" } } }, { "measure": "cumulative sufentanil consumption 0-24, 24-48, 0-48 h", "day": 1, "form": "mean_sd", "location": "Results, sufentanil sentence ('the first day', 0-24 h)", "values": { "Esketamine group": { "mean": "42.5", "sd": "4.58" }, "Control group": { "mean": "50.15", "sd": "5.47" } } }, { "measure": "cumulative sufentanil consumption 0-24, 24-48, 0-48 h", "day": 2, "form": "mean_sd", "location": "Results, sufentanil sentence ('the second day', 0-48 h)", "values": { "Esketamine group": { "mean": "87.40", "sd": "9.51" }, "Control group": { "mean": "95.10", "sd": "9.36" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 2 (analgesia-related adverse events)", "values": { "Esketamine group": { "dizziness": "21" }, "Control group": { "dizziness": "28" } } } ], "blinding_check": null, "enrollment": { "start": "2023-01", "end": "2023-09" }, "registration": { "number": "ChiCTR2200067054", "date": "2022-12-26" }, "note": "Per-arm randomized numbers are not printed (360 enrolled; after exclusions, including 29 lost to follow-up, 246 included; Fig. 1 not in text); analysed 124/122 are Table 1's 'Number' row. Day-42 EPDS and all NRS and sufentanil values are text pairs 'X vs. Y'; where the paper names the order (baseline EPDS, sufentanil) esketamine comes first, and the day-42 EPDS and NRS pairs are read the same way, which also fits the stated direction (Fig. 2 and 3 captions). NRS 24 h and 48 h are the 5th and 6th pairs of the rest sentence (2, 4, 8, 12, 24, 48 h). PPD (EPDS >= 13) at day 42 is given only as percentages, '22.2% and 10.7%', said to be esketamine and control 'respectively', which contradicts the same sentence's claim that esketamine was lower; no counts are printed, so there is no count entry. Sufentanil day 2 is the 'second day' figure, which the Fig. 2 caption identifies as 0-48 h; the 24-48 h interval was 43.50 +/- 5.34 vs 46.40 +/- 3.86 ug (esketamine vs control). Dizziness: Table 2 gives control 28 (22.95) and esketamine 21 (16.94), consistent with the arm sizes; the text gives these percentages to the opposite arms; the table is taken. The text places the side effects 'during the surgical procedure', but Methods record them 'throughout PCIA', so postoperative. Enrollment printed as 'January 1, 2023, to September 31, 2023'.", "decided_by": "both coders" }, { "trial": "T043", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "173", "analysed": "159" }, "Control group": { "randomized": "173", "analysed": "160" } }, "depression": [ { "measure": "Edinburgh Depression Scale (EPDS)", "day": 4, "form": "count", "definition": "EPDS > 9", "location": "Results, Primary outcome paragraph", "values": { "Esketamine group": { "events": "22", "n": "159" }, "Control group": { "events": "37", "n": "160" } } }, { "measure": "Edinburgh Depression Scale (EPDS)", "day": 42, "form": "percent", "definition": "EPDS > 9", "location": "Results, Primary outcome paragraph", "values": { "Esketamine group": { "percent": "17", "n": "159" }, "Control group": { "percent": "25", "n": "160" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "form": "percent", "location": "Results, Primary outcome paragraph (Fig. 6)", "values": { "Esketamine group": { "dizziness_percent": "17.0", "visual_percent": "5", "hallucination_percent": "3.8" } } } ], "blinding_check": null, "enrollment": { "start": "2020-07", "end": "2023-09" }, "registration": { "number": "ChiCTR2100053422", "date": "2021-11-20" }, "note": "Randomized 173 per group is from the sample-size paragraph ('173 patients were randomly assigned to each group') and matches the Results' flow (control 173 - 9 propofol - 4 lost = 160; esketamine 173 - 8 propofol - 1 albinism - 5 lost = 159). No EPDS means and no baseline EPDS by arm are printed (Figures 2 and 3 only). Day 4: the Results text gives the counts with postpartum depression (EPDS > 9, the Methods' cutoff), the esketamine count written as the word 'Twenty-two', with 13.8% vs 23.1%; n is not printed beside them, so the analysed numbers (159, 160) are given, which the percentages match (22/159, 37/160). Day 42: only percentages are printed ('17% vs 25%', esketamine first), entered in a 'percent' form with the analysed n for the code to convert. Pain: NRS at 6, 12, 24 and 48 h is shown by arm only in Figure 4, with no printed values (text: lower with esketamine at 6, 12 and 24 h, P < 0.05; at 48 h P = 0.1730); Table 2's NRS values are by depressed vs non-depressed group, not by arm, so there is no pain entry. Adverse events: the Results print only the esketamine group's percentages (dizziness 17.0%, blurred vision 5%, 'illusion' 3.8%, drowsiness 3.8%), with no counts and no control values (Figure 6 prints none); they are entered in a 'percent' form with a _percent suffix, so no count field holds a percentage. 'Illusion' is entered as hallucination (the Methods list hallucination among the recorded adverse reactions); drowsiness is not a codebook category. The time of adverse-event recording is not stated, so the window is 'overall'. Enrollment is as the Results state it ('From July 2020 to September 2023', which includes follow-up); the Methods say the study ran from July 1, 2020 to July 21, 2023, with the last follow-up on September 1, 2023. The registration (printed 20/11/2021) postdates the start of the study. Anaesthesiologists could not be blinded because of esketamine's side effects; parturients and the follow-up investigator were. Esketamine 0.2 mg/kg or saline pumped over 40 min from the start of the operation, under combined spinal-epidural anaesthesia.", "decided_by": "third reader" }, { "trial": "T044", "source": "fulltext", "arms": { "Group E": { "randomized": "60", "analysed": "58" }, "Group C": { "randomized": "60", "analysed": "59" } }, "depression": [ { "measure": "EPDS (with diagnostic criteria)", "day": 7, "form": "count", "definition": "PPD diagnosed from the EPDS score and the diagnostic criteria for mental disorders (refs 15, 16); cut-off not stated", "location": "Table 3 (PPD, 1 week)", "values": { "Group E": { "events": "2", "n": "58" }, "Group C": { "events": "9", "n": "59" } } }, { "measure": "EPDS (with diagnostic criteria)", "day": 42, "form": "count", "definition": "PPD diagnosed from the EPDS score and the diagnostic criteria for mental disorders (refs 15, 16); cut-off not stated", "location": "Table 3 (PPD, 6 weeks)", "values": { "Group E": { "events": "3", "n": "58" }, "Group C": { "events": "11", "n": "59" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 3", "values": { "Group E": { "nightmare": "2" }, "Group C": { "nightmare": "3" } } } ], "blinding_check": null, "enrollment": { "start": "2022-06-01", "end": "2023-02-28" }, "registration": { "number": "ChiCTR2200060387", "date": "2022-05-30" }, "note": "Vaginal delivery with labour analgesia; esketamine given after fetal disengagement, so days count from delivery (1 week = 7, 6 weeks = 42). Randomized per arm is from Methods ('A total of 120 samples were designed in this study, for 60 in each group respectively'); 120 enrolled, then 2 excluded in Group E (failed epidural puncture; changed to caesarean) and 1 in Group C (failed epidural puncture), leaving 58 and 59 analysed. Side effects (nightmares, drowsiness, nausea/vomiting) were recorded for 48 h after delivery; drowsiness (1 vs 1) and nausea/vomiting (2 vs 1) are not psychotomimetic categories. Enrollment dates are the trial period stated in Methods (6/1/2022 to 2/28/2023); Results give none. Registration date printed as 5/30/2022.", "decided_by": "both coders" }, { "trial": "T045", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "75", "analysed": "62" }, "Control group (saline; PCIA without esketamine)": { "randomized": "75", "analysed": "61" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 2 (Before surgery)", "values": { "Esketamine group": { "median": "7.0", "q1": "4.0", "q3": "10.0", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "median": "6.0", "q1": "3.0", "q3": "9.0", "n": "61" } } }, { "measure": "EPDS", "day": -1, "form": "count", "definition": "EPDS score ≥ 13 (PPD risk)", "location": "Table 2 (Before surgery)", "values": { "Esketamine group": { "events": "5", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "events": "6", "n": "61" } } }, { "measure": "EPDS", "day": 3, "form": "median_iqr", "location": "Table 2 (3 days postpartum)", "values": { "Esketamine group": { "median": "6.0", "q1": "2.0", "q3": "8.0", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "median": "6.0", "q1": "3.0", "q3": "9.0", "n": "61" } } }, { "measure": "EPDS", "day": 3, "form": "count", "definition": "EPDS score ≥ 13 (PPD risk)", "location": "Table 2 (3 days postpartum)", "values": { "Esketamine group": { "events": "4", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "events": "6", "n": "61" } } }, { "measure": "EPDS", "day": 42, "form": "median_iqr", "location": "Table 2 (42 days postpartum)", "values": { "Esketamine group": { "median": "5.0", "q1": "2.0", "q3": "8.0", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "median": "5.5", "q1": "3.0", "q3": "8.0", "n": "61" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "EPDS score ≥ 13 (PPD risk)", "location": "Table 2 (42 days postpartum)", "values": { "Esketamine group": { "events": "5", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "events": "8", "n": "61" } } }, { "measure": "EPDS", "day": 90, "form": "median_iqr", "location": "Table 2 (3 months postpartum)", "values": { "Esketamine group": { "median": "5.0", "q1": "1.5", "q3": "8.0", "n": "60" }, "Control group (saline; PCIA without esketamine)": { "median": "5.0", "q1": "2.0", "q3": "9.0", "n": "59" } } }, { "measure": "EPDS", "day": 90, "form": "count", "definition": "EPDS score ≥ 13 (PPD risk)", "location": "Table 2 (3 months postpartum)", "values": { "Esketamine group": { "events": "6", "n": "60" }, "Control group (saline; PCIA without esketamine)": { "events": "7", "n": "59" } } }, { "measure": "EPDS", "day": 180, "form": "median_iqr", "location": "Table 2 (6 months postpartum)", "values": { "Esketamine group": { "median": "4.0", "q1": "0.0", "q3": "8.0", "n": "57" }, "Control group (saline; PCIA without esketamine)": { "median": "5.5", "q1": "2.0", "q3": "9.0", "n": "57" } } }, { "measure": "EPDS", "day": 180, "form": "count", "definition": "EPDS score ≥ 13 (PPD risk)", "location": "Table 2 (6 months postpartum)", "values": { "Esketamine group": { "events": "4", "n": "57" }, "Control group (saline; PCIA without esketamine)": { "events": "6", "n": "57" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Table 4 (POD 1)", "values": { "Esketamine group": { "median": "2.0", "q1": "1.0", "q3": "2.0", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "median": "2.0", "q1": "1.0", "q3": "2.0", "n": "61" } } }, { "measure": "NRS at rest", "day": 2, "form": "median_iqr", "location": "Table 4 (POD 2)", "values": { "Esketamine group": { "median": "1.0", "q1": "0.0", "q3": "1.0", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "median": "1.0", "q1": "1.0", "q3": "1.0", "n": "61" } } }, { "measure": "NRS during coughing", "day": 1, "form": "median_iqr", "location": "Table 4 (POD 1)", "values": { "Esketamine group": { "median": "4.0", "q1": "3.0", "q3": "4.0", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "median": "4.0", "q1": "4.0", "q3": "5.0", "n": "61" } } }, { "measure": "NRS during coughing", "day": 2, "form": "median_iqr", "location": "Table 4 (POD 2)", "values": { "Esketamine group": { "median": "3.0", "q1": "2.0", "q3": "3.0", "n": "62" }, "Control group (saline; PCIA without esketamine)": { "median": "3.0", "q1": "3.0", "q3": "4.0", "n": "61" } } }, { "measure": "cumulative sufentanil consumption 0-48 h", "day": 1, "form": "mean_sd", "location": "Results 3.3, text (first 24 h)", "values": { "Esketamine group": { "mean": "37.8", "sd": "7.4" }, "Control group (saline; PCIA without esketamine)": { "mean": "47.3", "sd": "8.3" } } }, { "measure": "cumulative sufentanil consumption 0-48 h", "day": 2, "form": "mean_sd", "location": "Results 3.3, text (48 h)", "values": { "Esketamine group": { "mean": "74.5", "sd": "12.3" }, "Control group (saline; PCIA without esketamine)": { "mean": "86.4", "sd": "13.5" } } } ], "adverse_events": [ { "window": "intraoperative", "location": "Table 4", "values": { "Esketamine group": { "hallucination": "3", "nightmare": "1", "dizziness": "10" }, "Control group (saline; PCIA without esketamine)": { "hallucination": "0", "nightmare": "0", "dizziness": "2" } } }, { "window": "postoperative", "location": "Table 4", "values": { "Esketamine group": { "hallucination": "2", "nightmare": "1", "dizziness": "6" }, "Control group (saline; PCIA without esketamine)": { "hallucination": "0", "nightmare": "0", "dizziness": "4" } } } ], "blinding_check": null, "enrollment": { "start": "2021-05", "end": "2021-12" }, "registration": { "number": "ChiCTR2100046049", "date": null }, "note": "150 randomized; 75 per arm from the sample-size section ('we enrolled 75 patients in each group'), consistent with exclusions of 13 (6 withdrew consent, 7 lost) and 14 (8 withdrew, 6 lost); 62 and 61 analysed. The source calls the control arm 'control group' (saline infusion; PCIA without esketamine). EPDS baseline was a face-to-face interview one day before surgery; follow-up online at 3 days, 42 days, 3 months and 6 months (entered as days 3, 42, 90, 180); the 3- and 6-month n come from Table 2's subheadings, the others from its header. Methods state the PPD cut-off as 'EPDS score > 12'; Table 2 prints '≥ 13'. EPDS area under the curve 130.2 ± 115.9 vs 152.2 ± 126.6 not entered; EPDS-3A anxiety not entered. Sufentanil 0-24 h and 0-48 h from the Results text (no n); 0-12, 12-24 and 24-48 h only in Figure 2. Adverse events from Table 4; the Results text calls intraoperative dizziness 'significantly lower in the esketamine group' while printing 16.1 % vs 3.3 %, which matches Table 4's 10 (esketamine) vs 2 (control), so the table is taken. Nausea, vomiting and pruritus not coded. Enrollment period from Methods (trial 'conducted ... between May 2021 and December 2021'); the Results give no dates.", "decided_by": "third reader" }, { "trial": "T046", "source": "library", "arms": { "Placebo group": { "randomized": "100", "analysed": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "randomized": "100", "analysed": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "randomized": "100", "analysed": "99" } }, "depression": [ { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": -1, "form": "median_iqr", "location": "Results 3.3, text", "values": { "Placebo group": { "median": "12.0", "q1": "11.0", "q3": "13.0", "n": null }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "12.0", "q1": "10.0", "q3": "13.0", "n": null }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "11.0", "q1": "10.0", "q3": "13.0", "n": null } } }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 7, "form": "count", "location": "Table 2", "definition": "EPDS > 9 (PDS)", "values": { "Placebo group": { "events": "29", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "events": "11", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "events": "7", "n": "99" } } }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 7, "form": "count", "location": "Table 2", "definition": "remission: EPDS < 6 (from an antenatal EPDS > 9); events are remitters, not participants with depression", "values": { "Placebo group": { "events": "34", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "events": "56", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "events": "68", "n": "99" } }, "counts": "improvement" }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 7, "form": "median_iqr", "location": "Results 3.3, text (Fig. 2)", "values": { "Placebo group": { "median": "7.0", "q1": "4.0", "q3": "10.0", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "5.0", "q1": "2.0", "q3": "7.0", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "4.0", "q1": "1.0", "q3": "7.0", "n": "99" } } }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 7, "form": "change_median_iqr", "location": "Results 3.3, text (Fig. 3)", "values": { "Placebo group": { "median": "-5.0", "q1": "-9.0", "q3": "-2.0", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "-7.0", "q1": "-10.0", "q3": "-4.0", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "-8.0", "q1": "-10.0", "q3": "-5.0", "n": "99" } } }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 42, "form": "count", "location": "Table 2", "definition": "EPDS > 9 (PDS)", "values": { "Placebo group": { "events": "27", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "events": "14", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "events": "9", "n": "99" } } }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 42, "form": "count", "location": "Table 2", "definition": "remission: EPDS < 6 (from an antenatal EPDS > 9); events are remitters, not participants with depression", "values": { "Placebo group": { "events": "39", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "events": "58", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "events": "68", "n": "99" } }, "counts": "improvement" }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 42, "form": "median_iqr", "location": "Results 3.3, text (Fig. 2)", "values": { "Placebo group": { "median": "6.0", "q1": "3.0", "q3": "10.0", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "5.0", "q1": "2.0", "q3": "8.0", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "3.0", "q1": "1.0", "q3": "7.0", "n": "99" } } }, { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "day": 42, "form": "change_median_iqr", "location": "Results 3.3, text (Fig. 3)", "values": { "Placebo group": { "median": "-6.0", "q1": "-9.0", "q3": "-2.5", "n": "97" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "-7.00", "q1": "-10.0", "q3": "-4.0", "n": "99" }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "-8.0", "q1": "-10.0", "q3": "-5.0", "n": "99" } } } ], "pain": [ { "measure": "NRS postoperative pain", "day": 1, "form": "median_iqr", "location": "Results 3.3, text (at rest, 24 h; Fig. 4a)", "values": { "Placebo group": { "median": "2.0", "q1": "2.0", "q3": "3.0", "n": null }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "2.0", "q1": "1.0", "q3": "2.0", "n": null }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "2.0", "q1": "1.0", "q3": "3.0", "n": null } } }, { "measure": "NRS postoperative pain", "day": 2, "form": "median_iqr", "location": "Results 3.3, text (at rest, 48 h; Fig. 4a)", "values": { "Placebo group": { "median": "2.0", "q1": "2.0", "q3": "2.0", "n": null }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "1.0", "q1": "1.0", "q3": "2.0", "n": null }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "1.0", "q1": "1.0", "q3": "2.0", "n": null } } }, { "measure": "NRS score on movement", "day": 2, "form": "median_iqr", "location": "Results 3.3, text (on movement, 48 h; Fig. 4b)", "values": { "Placebo group": { "median": "4.0", "q1": "3.0", "q3": "5.0", "n": null }, "Low-dose esketamine group (1 mg/kg PCIA)": { "median": "4.0", "q1": "3.0", "q3": "4.0", "n": null }, "High-dose esketamine group (2 mg/kg PCIA)": { "median": "3.0", "q1": "3.0", "q3": "4.0", "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "location": "Table 3, Intraoperative events", "values": { "Placebo group": { "hallucination": "0", "dissociation": "0", "visual": "0", "dizziness": "2" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "hallucination": "2", "dissociation": "3", "visual": "1", "dizziness": "11" }, "High-dose esketamine group (2 mg/kg PCIA)": { "hallucination": "1", "dissociation": "1", "visual": "2", "dizziness": "14" } } }, { "window": "postoperative", "location": "Table 3, Postoperative events", "values": { "Placebo group": { "dizziness": "3" }, "Low-dose esketamine group (1 mg/kg PCIA)": { "dizziness": "4" }, "High-dose esketamine group (2 mg/kg PCIA)": { "dizziness": "3" } } } ], "blinding_check": null, "enrollment": { "start": "2020-12", "end": "2022-01", "location": "Methods 2.1 (study conducted from December 2020 to January 2022); the Results give no dates" }, "registration": { "number": "ChiCTR-ROC-2000039069", "date": null }, "note": "Tables print the esketamine columns first ('PCIA esketamine 2 mg kg−1' = High-dose, '1 mg kg−1' = Low-dose), then Placebo. Randomized 100 per arm (Results 3.1: 300 randomized, 295 completed); analysed 99 (2 mg), 99 (1 mg), 97 (placebo), the column n of Tables 1-3 and the abstract. Counts from Table 2: PDS (EPDS > 9, the primary outcome) and remission (EPDS < 6, from an antenatal EPDS > 9); the remission entries count remitters, not participants with depression, as their definition says. Table 2's percentages use its column n at both days (29/97 = 29.9 %, 11/99 = 11.1 %), so that n is the number assessed at days 7 and 42 and is given for the EPDS medians and changes at those days; the baseline n is not printed. Table 2 also prints ORs vs placebo for both counts (not entered, since the arm counts are given). EPDS medians (IQR) and median (IQR) changes from baseline ('antenatal day 1', coded day -1) are from the Results 3.3 text; Figs 2 and 3 print no values. Day 7 medians are printed pairwise (placebo 7.0 [4.0, 10.0] vs low 5.0 [2.0, 7.0], and vs high 4.0 [1.0, 7.0]); day 42 likewise (high 3.0 [1.0, 7.0] vs placebo 6.0 [3.0, 10.0], and vs low 5.0 [2.0, 8.0]). The text once calls the change a 'mean change' but prints median (IQR). Minus signs printed as '− ' are written '-'; the low-dose day 42 change is printed '− 7.00'. NRS: at-rest medians are printed for 6, 24 and 48 h (6 h is outside the day windows; the low-dose 48 h value is printed '1.0 [1.0, 2.0;'); on movement only the 48 h values are printed (24 h: 'no significant differences'), entered under the source's name since the design lists one NRS measure. Adverse events from Table 3: nystagmus = visual; intraoperative dysphoria (2 mg 1, 1 mg 1, placebo 0), muscular hypertonia, nausea, vomit, shiver, hypertension and cold sweat are not codebook categories; the text's 'several mild psychiatric adverse effects' gives no count. CADSS was planned at 40 min, but only Table 3's dissociation counts are reported. Enrollment is from Methods 2.1 (the Results give no dates). Blinding: the Limitations say participants were not asked which group they thought they were in.", "decided_by": "third reader" }, { "trial": "T049", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "78", "analysed": "75" }, "Normal saline group": { "randomized": "78", "analysed": "76" } }, "depression": [ { "measure": "Beck Depression Inventory-II (BDI-II)", "day": -1, "form": "count", "definition": "BDI-II ≥ 14 (0–13 absent)", "location": "Table 1", "values": { "Esketamine group": { "events": "0", "n": "78" }, "Normal saline group": { "events": "2", "n": "78" } } }, { "measure": "Beck Depression Inventory-II (BDI-II)", "day": 2, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "6", "q1": "5", "q3": "8", "n": "78" }, "Normal saline group": { "median": "6", "q1": "5", "q3": "8", "n": "78" } } }, { "measure": "Beck Depression Inventory-II (BDI-II)", "day": 2, "form": "count", "definition": "BDI-II ≥ 14 (0–13 absent)", "location": "Table 3", "values": { "Esketamine group": { "events": "0", "n": "78" }, "Normal saline group": { "events": "1", "n": "78" } } }, { "measure": "Beck Depression Inventory-II (BDI-II)", "day": 30, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "5", "q1": "4", "q3": "7", "n": "75" }, "Normal saline group": { "median": "5", "q1": "4", "q3": "8", "n": "76" } } }, { "measure": "Beck Depression Inventory-II (BDI-II)", "day": 30, "form": "count", "definition": "BDI-II ≥ 14 (0–13 absent)", "location": "Table 3", "values": { "Esketamine group": { "events": "1", "n": "75" }, "Normal saline group": { "events": "9", "n": "76" } } }, { "measure": "Beck Depression Inventory-II (BDI-II)", "day": 90, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "1.5", "q1": "0", "q3": "4", "n": "74" }, "Normal saline group": { "median": "2", "q1": "0", "q3": "5", "n": "76" } } }, { "measure": "Beck Depression Inventory-II (BDI-II)", "day": 90, "form": "count", "definition": "BDI-II ≥ 14 (0–13 absent)", "location": "Table 3", "values": { "Esketamine group": { "events": "0", "n": "74" }, "Normal saline group": { "events": "1", "n": "76" } } } ], "pain": [ { "measure": "VAS at rest", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "0", "q1": "0", "q3": "1", "n": "78" }, "Normal saline group": { "median": "0", "q1": "0", "q3": "1", "n": "78" } } }, { "measure": "VAS at rest", "day": 2, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "0", "q1": "0", "q3": "1", "n": "78" }, "Normal saline group": { "median": "0", "q1": "0", "q3": "0", "n": "78" } } }, { "measure": "VAS on coughing", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "3", "q1": "0", "q3": "5", "n": "78" }, "Normal saline group": { "median": "3", "q1": "2", "q3": "5", "n": "78" } } }, { "measure": "VAS on coughing", "day": 2, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "3", "q1": "3", "q3": "6", "n": "78" }, "Normal saline group": { "median": "3", "q1": "2", "q3": "4", "n": "78" } } }, { "measure": "PCIA sufentanil consumption 0-24 and 0-48 h", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "42.2", "q1": "37.8", "q3": "52.5", "n": "78" }, "Normal saline group": { "median": "42", "q1": "38.5", "q3": "49.3", "n": "78" } } }, { "measure": "PCIA sufentanil consumption 0-24 and 0-48 h", "day": 2, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "87.8", "q1": "77.1", "q3": "101.6", "n": "78" }, "Normal saline group": { "median": "85.2", "q1": "78.1", "q3": "99.4", "n": "78" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "nightmare": "1", "dizziness": "18", "visual": "1", "dissociation": "0" }, "Normal saline group": { "nightmare": "4", "dizziness": "17", "visual": "2", "dissociation": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-05", "end": "2022-05" }, "registration": { "registry": "Chinese Clinical Trial Registry", "number": null, "date": "2021-05-09" }, "note": "BDI-II scores (Table 3) are median (IQR); the 48-h rows print no n of their own, so they carry the column n = 78, while the 1- and 3-month rows print theirs. Depressive symptoms = BDI-II of 14 or more (0–13 absent, per Methods). Day 30 counts are the modified ITT population (after excluding patients without lung cancer: 1/72 vs 9/74). BDI-II at hospital discharge has no fixed day (median postoperative stay 4 and 5 days), so it is not coded: score 6 (5, 7) vs 6 (5, 8), depressive symptoms 0 vs 4 (5.1%), esketamine vs saline. No baseline BDI-II score is reported, only the count of depressive symptoms 1 day before surgery (Table 1). Pain (Table 2) is median (IQR) with column n = 78; sufentanil 0–24 h is coded at day 1 and 0–48 h at day 2 (cumulative, μg). Adverse events are within 0–48 h after surgery (Table 2); blurred vision coded as visual; delirium (0 vs 0) not coded. Registered with the Chinese Clinical Trial Registry on 9 May 2021, before the first enrolment; the number is not in the text.", "decided_by": "both coders" }, { "trial": "T050", "source": "fulltext", "arms": { "Ketamine group": { "randomized": null, "analysed": "15" }, "Placebo group": { "randomized": null, "analysed": "15" } }, "depression": [ { "measure": "Patient Health Questionnaire-2 (PHQ-2)", "day": -1, "form": "count", "location": "Table 1", "definition": "PHQ-2 ≥ 3", "values": { "Ketamine group": { "events": "3", "n": "15" }, "Placebo group": { "events": "2", "n": "15" } } }, { "measure": "Patient Health Questionnaire-2 (PHQ-2)", "day": -1, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.75", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "Patient Health Questionnaire-2 (PHQ-2)", "day": 7, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.96", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } } ], "pain": [ { "measure": "BPI pain severity subscale", "day": 1, "form": "difference", "location": "Table 3", "estimate": "-0.50", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.55", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI pain severity subscale", "day": 2, "form": "difference", "location": "Table 3", "estimate": "0.25", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.82", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI average", "day": 1, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.65", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI average", "day": 2, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.92", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI worst", "day": 1, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.90", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI worst", "day": 2, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.90", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI least", "day": 1, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.61", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI least", "day": 2, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.97", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI current", "day": 1, "form": "difference", "location": "Table 3", "estimate": "-1", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.23", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "BPI current", "day": 2, "form": "difference", "location": "Table 3", "estimate": "-1", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.52", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "opioid usage", "day": 1, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.83", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } }, { "measure": "opioid usage", "day": 2, "form": "difference", "location": "Table 3", "estimate": "0", "lower": null, "upper": null, "level": null, "scale": "median_difference", "comparison": "Ketamine group minus Placebo group (Table 3: Ketamine – Control)", "p": "0.81", "values": { "Ketamine group": { "n": null }, "Placebo group": { "n": null } } } ], "adverse_events": [ { "window": "postoperative", "time": "POD 0, 30 minutes after the infusion (given in the PACU)", "location": "Results, text", "values": { "Ketamine group": { "any_ae": "7" }, "Placebo group": { "any_ae": "7" } } }, { "window": "postoperative", "time": "POD 1", "location": "Results, text", "values": { "Ketamine group": { "any_ae": "8" }, "Placebo group": { "any_ae": "5" } } } ], "blinding_check": null, "enrollment": { "start": "2021-04", "end": "2022-04", "location": "Methods (study performed from April 2021 to April 2022); the Results give no dates" }, "registration": { "number": "NCT04831736", "date": "05/04/2021" }, "note": "Single-blind pilot; ketamine 0.6 mg/kg over about 45 min in the PACU. 31 randomized; 1 withdrawn on the day of surgery before receiving the intervention (arm not stated, CONSORT figure not printed), so randomized per arm is not given; analysed 15 per arm (Table 1 'Ketamine (n=15)', 'Control (n=15)'; Control = Placebo group). Table 3 gives only Wilcoxon median differences (Ketamine – Control) with P values, no arm-level values, for PHQ-2 (baseline, POD 7), BPI (baseline, POD 0, 1, 2, 7) and opioid use (POD 0, 1, 2, 7); minus signs written '-'. 'BPI pain severity subscale' is Table 3's row 'BPI mean' (arithmetic mean of the 4 items); the item rows (average, worst, least, current) are recorded under their own names. POD 1 = 24 h and POD 2 = 48 h (the primary endpoint). Baseline PHQ-2 ≥ 3 counts from Table 1. Side effects: the text spells out 'seven (46.7%) subjects in each group' 30 minutes after the infusion on POD 0, and 'eight (53.3%)' ketamine vs 'five (33.3%)' placebo on POD 1, reporting some side effect; per-symptom counts are only in Figure 3 (no printed values). Blinding: participants guessed their assignment on POD 1, but only 'no statistically significant difference between groups ... (p = 0.07)' is reported, no guesses by arm. BCPQ (POD 7 only) not recorded. Registration date is the 'first posted' date, printed '05/04/2021' (day and month order not stated).", "decided_by": "both coders" }, { "trial": "T051", "source": "library", "arms": { "P group (propofol alone)": { "randomized": "35", "analysed": "35" }, "S group (propofol with esketamine)": { "randomized": "35", "analysed": "35" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "mean_sd", "location": "Results, EPDS paragraph", "values": { "P group (propofol alone)": { "mean": "12", "sd": "2.47" }, "S group (propofol with esketamine)": { "mean": "12.46", "sd": "2.73" } } }, { "measure": "EPDS", "day": 7, "form": "mean_sd", "location": "Results, EPDS paragraph", "values": { "P group (propofol alone)": { "mean": "8.63", "sd": "3.14" }, "S group (propofol with esketamine)": { "mean": "6.34", "sd": "2.87" } } }, { "measure": "EPDS", "day": 42, "form": "mean_sd", "location": "Results, EPDS paragraph", "values": { "P group (propofol alone)": { "mean": "9.4", "sd": "2.67" }, "S group (propofol with esketamine)": { "mean": "5.31", "sd": "2.49" } } }, { "measure": "EPDS", "day": -1, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, EPDS paragraph", "values": { "P group (propofol alone)": { "events": "35" }, "S group (propofol with esketamine)": { "events": "35" } } }, { "measure": "EPDS", "day": 7, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, EPDS paragraph", "values": { "P group (propofol alone)": { "events": "13" }, "S group (propofol with esketamine)": { "events": "3" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, EPDS paragraph", "values": { "P group (propofol alone)": { "events": "13" }, "S group (propofol with esketamine)": { "events": "2" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "values": { "P group (propofol alone)": { "agitation": "0" }, "S group (propofol with esketamine)": { "agitation": "2" } } } ], "blinding_check": null, "enrollment": { "start": "2022-03", "end": "2022-08" }, "registration": { "number": "ChiCTR2200058731", "date": null }, "note": "EPDS values are in the Results text only (no table). The n's printed beside each time ('≥10 scores on 1d (n = 35) before the operation and 7d (n = 13), and 42d (n = 13)') are the numbers with EPDS ≥ 10, recorded as count events, not the numbers assessed; the means are whole-arm means (the abstract compares them between groups). Results say 'no lapses in the blinding and follow-up, and all patients were included in the final intention-to-treat analyses', so 35 per arm at every time, though no n is printed beside the values. P group day 42 mean is '9.4' in the Results and '9.40' in the abstract; took the Results. Baseline is 'preoperative 1 d'. VAS was measured only at 1 h after surgery (abstract: 3.51 ± 1.12 vs 2.80 ± 0.83 vs 2.40 ± 0.81 for P, D, S; VAS > 3 in 48.57%, 14.29%, 2.86%), outside the day 1 and day 2 windows, so no pain entries. AEs from Table 3 ('Complications'), recorded 'during and after recovery', hence window overall; 'Delirium' coded as agitation; respiratory depression and nausea/vomiting not coded. D group (dezocine, role other) not extracted. Enrollment from Methods ('scheduled ... from March to August 2022'); the Results state only that the final visit was completed on August 15, 2022. Registered 'before patient enrollment', no date given.", "decided_by": "both coders" }, { "trial": "T052", "source": "fulltext", "arms": { "Group E": { "randomized": "60", "analysed": "58" }, "Group C": { "randomized": "60", "analysed": "57" } }, "depression": [ { "measure": "DSM-IV clinical interview for PPD", "day": 7, "form": "count", "definition": "PPD: EPDS > 9 screen, then DSM-IV clinical interview", "location": "Table 2", "values": { "Group E": { "events": "2", "n": "58" }, "Group C": { "events": "9", "n": "57" } } }, { "measure": "DSM-IV clinical interview for PPD", "day": 42, "form": "count", "definition": "PPD: EPDS > 9 screen, then DSM-IV clinical interview", "location": "Table 2", "values": { "Group E": { "events": "3", "n": "58" }, "Group C": { "events": "11", "n": "57" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "time": "within 48 h after the operation", "location": "Table 2", "n": { "Group E": "58", "Group C": "57" }, "terms": { "nightmare": "Nightmares" }, "values": { "Group E": { "nightmare": "2" }, "Group C": { "nightmare": "3" } } } ], "blinding_check": null, "enrollment": { "start": "2022-04-01", "end": "2022-11-30" }, "registration": { "number": "ChiCTR2200060387", "date": "2022-05-30" }, "note": "Table 2 'PPD' counts use the paper's two-step definition (EPDS > 9 screen, then a DSM-IV clinical interview by physicians blind to group), so they are entered under 'DSM-IV clinical interview for PPD'; the number screening positive on the EPDS is not reported separately, so 'EPDS screen (>9)' has no entry. Results text repeats the percentages (1 week 15.8% vs 3.4%; 6 weeks 19.3% vs 5.2%, C vs E). Randomized 60 per group (Methods 2.3, 'with 60 cases in each group'). Of the Table 2 adverse reactions (within 48 h), only nightmares map to a category (drowsiness is not dizziness). Enrollment dates come from Methods 2.2 and 2.5; the Results don't restate them. Registration (30 May 2022) is after enrollment began (1 April 2022).", "decided_by": "third reader" }, { "trial": "T053", "source": "fulltext", "arms": { "Group S": { "randomized": null, "analysed": "53" }, "Group P": { "randomized": null, "analysed": "53" } }, "depression": [ { "measure": "Hamilton Depression Scale (HAMD)", "day": -1, "form": "mean_sd", "location": "Table 3", "values": { "Group S": { "mean": "10.0", "sd": "2.8", "n": null }, "Group P": { "mean": "9.6", "sd": "3.0", "n": null } } }, { "measure": "Hamilton Depression Scale (HAMD)", "day": 3, "form": "mean_sd", "location": "Table 3", "values": { "Group S": { "mean": "9.0", "sd": "1.8", "n": null }, "Group P": { "mean": "9.3", "sd": "2.9", "n": null } } }, { "measure": "Hamilton Depression Scale (HAMD)", "day": 7, "form": "mean_sd", "location": "Table 3", "values": { "Group S": { "mean": "9.8", "sd": "1.6", "n": null }, "Group P": { "mean": "9.1", "sd": "2.7", "n": null } } }, { "measure": "Hamilton Depression Scale (HAMD)", "day": 30, "form": "mean_sd", "location": "Table 3", "values": { "Group S": { "mean": "9.8", "sd": "2.6", "n": null }, "Group P": { "mean": "10.0", "sd": "3.0", "n": null } } } ], "pain": [ { "measure": "NRS pain", "day": 1, "form": "median_iqr", "location": "Table 3", "values": { "Group S": { "median": "2", "q1": "2", "q3": "4", "n": null }, "Group P": { "median": "3", "q1": "2", "q3": "4.5", "n": null } } }, { "measure": "NRS pain", "day": 2, "form": "median_iqr", "location": "Table 3", "values": { "Group S": { "median": "1", "q1": "1", "q3": "2", "n": null }, "Group P": { "median": "2", "q1": "1", "q3": "3", "n": null } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2022-04", "end": "2022-07" }, "registration": { "registry": "Chinese Clinical Trial Registry", "number": "ChiCTR2100049857", "date": null }, "note": "118 women enrolled; 4 (surgery cancelled) and 8 (changed surgical modality) were excluded, leaving 53 per group; the numbers randomized per group are only in Figure 1 (not in the text). Table 3 gives no n per time point. HAMD (mean ± SD) at 72 h coded as day 3; the 7- and 30-day values were collected by telephone. NRS pain (Table 3) is median (IQR): 24 h coded day 1, 48 h day 2; the 8-h, 72-h, 7-day and 30-day values and the NRS 10 min after extubation (Table 2) fall outside the pain days. Adverse reactions are only in Table S1, not in the text. Enrollment is from Methods (recruited April to July 2022). Registered before enrolment; no date given.", "decided_by": "both coders" }, { "trial": "T054", "source": "fulltext", "arms": { "Group S (esketamine + butorphanol)": { "randomized": "80", "analysed": "78" }, "Group C (butorphanol)": { "randomized": "80", "analysed": "77" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative EPDS score)", "values": { "Group S (esketamine + butorphanol)": { "median": "3", "q1": "2", "q3": "4", "n": null }, "Group C (butorphanol)": { "median": "3", "q1": "2", "q3": "4", "n": null } } }, { "measure": "EPDS", "day": 0, "form": "difference", "location": "Results, 'EPDS scores at different time points' (postoperative 8 h); Fig. 2 has no printed values", "estimate": null, "lower": "1", "upper": "2", "level": "0.95", "scale": null, "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)", "values": { "Group S (esketamine + butorphanol)": { "n": "78" }, "Group C (butorphanol)": { "n": "77" } } }, { "measure": "EPDS", "day": 1, "form": "difference", "location": "Results, 'EPDS scores at different time points' (postoperative 24 h); Fig. 2 has no printed values", "estimate": null, "lower": "1", "upper": "2", "level": "0.95", "scale": null, "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)", "values": { "Group S (esketamine + butorphanol)": { "n": "78" }, "Group C (butorphanol)": { "n": "77" } } }, { "measure": "EPDS", "day": 4, "form": "difference", "location": "Results, 'EPDS scores at different time points' (postoperative 96 h); Fig. 2 has no printed values", "estimate": null, "lower": "1", "upper": "2", "level": "0.95", "scale": null, "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)", "values": { "Group S (esketamine + butorphanol)": { "n": "78" }, "Group C (butorphanol)": { "n": "77" } } }, { "measure": "EPDS", "day": 7, "form": "difference", "location": "Results, 'EPDS scores at different time points' (one week); Fig. 2 has no printed values", "estimate": null, "lower": "1", "upper": "2", "level": "0.95", "scale": null, "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)", "values": { "Group S (esketamine + butorphanol)": { "n": "78" }, "Group C (butorphanol)": { "n": "77" } } } ], "pain": [ { "measure": "PCIA presses in 24 h", "day": 1, "form": "median_iqr", "location": "Table 2 (PCA compressions)", "values": { "Group S (esketamine + butorphanol)": { "median": "10", "q1": "5", "q3": "22", "n": null }, "Group C (butorphanol)": { "median": "12", "q1": "6", "q3": "18", "n": null } } }, { "measure": "VAS", "day": 1, "form": "median_iqr", "location": "Table 2 (VAS scores, postoperative 24 h)", "values": { "Group S (esketamine + butorphanol)": { "median": "2", "q1": "2", "q3": "3", "n": null }, "Group C (butorphanol)": { "median": "3", "q1": "2", "q3": "3", "n": null } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Group S (esketamine + butorphanol)": { "dizziness": "15", "nightmare": "2", "agitation": "2", "hallucination": "1", "visual": "0" }, "Group C (butorphanol)": { "dizziness": "4", "nightmare": "1", "agitation": "2", "hallucination": "0", "visual": "1" } } } ], "blinding_check": null, "enrollment": { "start": "2022-01", "end": "2022-08" }, "registration": { "number": "ChiCTR2100054435", "date": "2021-12-27" }, "note": "Tables list Group C before Group S. Randomized 80 per arm from the sample-size paragraph ('a total of 160 patients (80 patients per arm) were recruited'); Results: 160 randomized, 5 excluded (3 excessive blood loss, 2 switched to general anaesthesia), final analysis Group S n = 78, Group C n = 77. No table prints a per-column n, so n is null in the median_iqr entries (Table 1's ASA counts sum to 78 and 77, the analysed patients). Postoperative EPDS (8 h, 24 h, 96 h, one week; days 0, 1, 4, 7) is plotted only in Fig. 2, with no printed values; the text gives for each time only 'P < 0.001, 95 % CI (1−2)', with no point estimate, so these are difference entries with estimate null and the analysed arm n's. The CI is positive while group S scored lower, so it appears to be group C minus group S (the paper's relative risks are likewise C relative to S, e.g. dizziness RR 0.270 = (4/77)/(15/78)). The estimator is not named: non-normal data were analysed with the Mann-Whitney U test, and integer bounds (the VAS CIs include '(0−0)') suggest Hodges-Lehmann median differences, but the source does not say so, so scale is null. Table 2 does not label its form; median (IQR) from Table 1's footnote, the text ('[12 (6−18)]'), and the Methods. PCA presses: the text gives group S '10 (5–22.25)', Table 2 '10 (5−22)'; the table's value is used. VAS at 8 h and 96 h are outside the pain windows; VAS at 48 h was planned but not reported. Rescue (diclofenac) analgesia over an unstated postoperative period, C 19 % (15/77) vs S 23 % (18/78), not coded. Adverse events (Table 5, after surgery): restlessness coded as agitation, blurred vision as visual. Enrollment dates from Methods (patients recruited January 2022 to August 2022; Results give none).", "decided_by": "third reader" }, { "trial": "T055", "source": "fulltext", "arms": { "S group": { "randomized": "75", "analysed": "66" }, "C group": { "randomized": "75", "analysed": "63" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "mean_sd", "location": "Table 3 (EPDS score, Before operation)", "values": { "S group": { "mean": "4.12", "sd": "0.64", "n": "66" }, "C group": { "mean": "4.08", "sd": "0.63", "n": "65" } } }, { "measure": "EPDS", "day": 3, "form": "mean_sd", "location": "Table 3 (EPDS score, 3 days after surgery)", "values": { "S group": { "mean": "6.42", "sd": "0.75", "n": "66" }, "C group": { "mean": "6.95", "sd": "0.58", "n": "65" } } }, { "measure": "EPDS", "day": 3, "form": "count", "definition": "EPDS ≥ 10", "location": "Table 3 (Occurrence of postpartum depression, 3 days after surgery)", "values": { "S group": { "events": "0", "n": "66", "definition": "EPDS ≥ 10" }, "C group": { "events": "0", "n": "65", "definition": "EPDS ≥ 10" } } }, { "measure": "EPDS", "day": 7, "form": "mean_sd", "location": "Table 3 (EPDS score, 7 days after surgery)", "values": { "S group": { "mean": "8.58", "sd": "0.88", "n": "66" }, "C group": { "mean": "9.05", "sd": "0.63", "n": "65" } } }, { "measure": "EPDS", "day": 7, "form": "count", "definition": "EPDS ≥ 10", "location": "Table 3 (Occurrence of postpartum depression, 7 days after surgery)", "values": { "S group": { "events": "8", "n": "66", "definition": "EPDS ≥ 10" }, "C group": { "events": "8", "n": "65", "definition": "EPDS ≥ 10" } } }, { "measure": "EPDS", "day": 14, "form": "mean_sd", "location": "Table 3 (EPDS score, 14 days after surgery)", "values": { "S group": { "mean": "5.86", "sd": "0.76", "n": "66" }, "C group": { "mean": "6.21", "sd": "0.68", "n": "65" } } }, { "measure": "EPDS", "day": 14, "form": "count", "definition": "EPDS ≥ 10", "location": "Table 3 (Occurrence of postpartum depression, 14 days after surgery)", "values": { "S group": { "events": "0", "n": "66", "definition": "EPDS ≥ 10" }, "C group": { "events": "0", "n": "65", "definition": "EPDS ≥ 10" } } } ], "pain": [ { "measure": "VAS at rest", "day": 1, "form": "mean_sd", "location": "Table 3 (T2 VAS score (static), 24 h)", "values": { "S group": { "mean": "3.50", "sd": "0.50", "n": "66" }, "C group": { "mean": "4.17", "sd": "0.38", "n": "65" } } }, { "measure": "VAS at rest", "day": 2, "form": "mean_sd", "location": "Table 3 (T3 VAS score (static), 48 h)", "values": { "S group": { "mean": "2.00", "sd": "0.00", "n": "66" }, "C group": { "mean": "2.06", "sd": "0.25", "n": "65" } } }, { "measure": "VAS on movement", "day": 1, "form": "mean_sd", "location": "Table 3 (T2 VAS score (move), 24 h)", "values": { "S group": { "mean": "4.50", "sd": "0.54", "n": "66" }, "C group": { "mean": "5.17", "sd": "0.38", "n": "65" } } }, { "measure": "VAS on movement", "day": 2, "form": "mean_sd", "location": "Table 3 (T3 VAS score (move), 48 h)", "values": { "S group": { "mean": "3.00", "sd": "0.00", "n": "66" }, "C group": { "mean": "3.06", "sd": "0.25", "n": "65" } } }, { "measure": "effective PCIA presses at 48 h", "day": 2, "form": "mean_sd", "location": "Table 3 (Total number of PCIA compressions in 48 hours)", "values": { "S group": { "mean": "7.58", "sd": "1.50", "n": "66" }, "C group": { "mean": "14.75", "sd": "1.78", "n": "65" } } } ], "adverse_events": [ { "window": "intraoperative", "time": "5 min after administration", "location": "Table 2", "n": { "S group": "66", "C group": "63" }, "terms": { "visual": "Nystagmus", "dizziness": "Dizziness", "hallucination": "Hallucinations" }, "values": { "S group": { "visual": "65", "dizziness": "63", "hallucination": "25" }, "C group": { "visual": "0", "dizziness": "0", "hallucination": "0" } } }, { "window": "intraoperative", "time": "15 min after administration", "location": "Table 2", "n": { "S group": "66", "C group": "63" }, "terms": { "visual": "Nystagmus", "dizziness": "Dizziness", "hallucination": "Hallucinations" }, "values": { "S group": { "visual": "4", "dizziness": "6", "hallucination": "8" }, "C group": { "visual": "0", "dizziness": "0", "hallucination": "0" } } }, { "window": "postoperative", "time": "on leaving the operating room", "location": "Table 2", "n": { "S group": "66", "C group": "63" }, "terms": { "visual": "Diplopia", "dizziness": "Dizziness", "hallucination": "Hallucinations" }, "values": { "S group": { "visual": "1", "dizziness": "1", "hallucination": "0" }, "C group": { "visual": "0", "dizziness": "0", "hallucination": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2024-02-16", "end": "2024-04-30" }, "registration": { "number": "ChiCTR2400080884", "date": "2024-02-15" }, "note": "Arm sizes: 75 randomized per group; 2 S and 4 C were excluded for blood loss > 500 mL and 7 S and 8 C were lost to follow-up, leaving 66 and 63 (129 analysed), as in Table 1 (N) and Table 2 (n). Table 3, the outcome table, heads the C column n = 65; the outcome entries copy Table 3's printed n (66 and 65), while 'analysed' is 63. Printed C figures are mixed: Table 3's PPD at day 7, 8 (12.7%), and adjuvant analgesia, 19 (30.2%), fit 63, while Table 2's visceral traction pain, 39 (60.0%), and Table 1's ASA II row, 65 (100%), fit 65. EPDS is in Table 3 both as mean ± SD and as 'Occurrence of postpartum depression' at 3, 7, and 14 days, which Methods 2.6 define as EPDS ≥ 10. Pain: VAS was measured at 4 h (T1, outside the day windows, left out), 24 h (T2, day 1), and 48 h (T3, day 2); 'static' is at rest and 'move' on movement. 'Postoperative adjuvant analgesia' (S 2 (3.00%), C 19 (30.2%)) is not a design measure and has no time, so it is left out. Adverse events are Table 2's counts at 5 and 15 min after the study drug (given within 10 min of cord clamping, so intraoperative) and on leaving the operating room (postoperative), one entry per time ('time'). Table 2 prints nystagmus and diplopia as separate rows (S nystagmus 65, 4, 0 and diplopia 7, 1, 1 at 5 min, 15 min, and leaving the operating room; C 0 throughout); 'visual' is the larger of the two at each time ('terms' names the row), since participants with both can't be told apart and the sum would exceed the arm at 5 min. S dizziness and diplopia on leaving the operating room print as '1 (0%)'; the count is copied. The Results text also names blurred vision as more frequent at 5 min, with no count. Drowsiness, lacrimation, nausea, vomiting, Ramsay > 3, and visceral traction pain are not codebook categories. Enrollment dates are from Methods 2.2 (the Results don't restate them); registered on 15 February 2024, the day before enrollment began.", "decided_by": "third reader" }, { "trial": "T057", "source": "fulltext", "arms": { "Low-dose group": { "randomized": null, "analysed": "97" }, "High-dose group": { "randomized": null, "analysed": "97" }, "Control group": { "randomized": null, "analysed": "98" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "mean_sd", "location": "Table 3 (Prenatal 1 day)", "values": { "Low-dose group": { "mean": "7.5", "sd": "2.2", "n": "97" }, "High-dose group": { "mean": "7.2", "sd": "2.3", "n": "97" }, "Control group": { "mean": "7.3", "sd": "2.3", "n": "98" } } }, { "measure": "EPDS", "day": 2, "form": "mean_sd", "location": "Table 3 (Postoperative 2 day)", "values": { "Low-dose group": { "mean": "7.2", "sd": "2.2", "n": "97" }, "High-dose group": { "mean": "7.5", "sd": "2.6", "n": "97" }, "Control group": { "mean": "8.8", "sd": "3.4", "n": "98" } } }, { "measure": "EPDS", "day": 7, "form": "mean_sd", "location": "Table 3 (Postoperative 7 day)", "values": { "Low-dose group": { "mean": "7.3", "sd": "3.1", "n": "97" }, "High-dose group": { "mean": "7.0", "sd": "2.9", "n": "97" }, "Control group": { "mean": "9.1", "sd": "3.3", "n": "98" } } }, { "measure": "EPDS", "day": 42, "form": "mean_sd", "location": "Table 3 (Postoperative 42 day)", "values": { "Low-dose group": { "mean": "8.3", "sd": "3.1", "n": "97" }, "High-dose group": { "mean": "8.1", "sd": "3.0", "n": "97" }, "Control group": { "mean": "8.8", "sd": "3.6", "n": "98" } } }, { "measure": "EPDS", "day": 2, "form": "count", "definition": "postpartum depression, EPDS ≥ 13", "location": "Table 4 (Postoperative 2 day)", "values": { "Low-dose group": { "events": "5", "n": "97" }, "High-dose group": { "events": "6", "n": "97" }, "Control group": { "events": "14", "n": "98" } } }, { "measure": "EPDS", "day": 7, "form": "count", "definition": "postpartum depression, EPDS ≥ 13", "location": "Table 4 (Postoperative 7 day)", "values": { "Low-dose group": { "events": "8", "n": "97" }, "High-dose group": { "events": "5", "n": "97" }, "Control group": { "events": "16", "n": "98" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "postpartum depression, EPDS ≥ 13", "location": "Table 4 (Postoperative 42 day)", "values": { "Low-dose group": { "events": "11", "n": "97" }, "High-dose group": { "events": "10", "n": "97" }, "Control group": { "events": "17", "n": "98" } } } ], "pain": [ { "measure": "VAS pain", "day": 1, "form": "mean_sd", "location": "Table 2 (Postoperative 24 hours)", "values": { "Low-dose group": { "mean": "3.1", "sd": "1.0", "n": "97" }, "High-dose group": { "mean": "2.7", "sd": "0.8", "n": "97" }, "Control group": { "mean": "3.5", "sd": "1.2", "n": "98" } } }, { "measure": "VAS pain", "day": 2, "form": "mean_sd", "location": "Table 2 (Postoperative 48 hours)", "values": { "Low-dose group": { "mean": "2.1", "sd": "0.6", "n": "97" }, "High-dose group": { "mean": "2.1", "sd": "0.7", "n": "97" }, "Control group": { "mean": "2.4", "sd": "1.1", "n": "98" } } }, { "measure": "rescue acetaminophen", "day": 2, "form": "count", "definition": "rescue acetaminophen (given when VAS > 4) within the first 2 days postoperatively", "location": "Table 2 (Rescue rate, n (%)); Results, Comparison of postoperative analgesia", "values": { "Low-dose group": { "events": "15", "n": "97" }, "High-dose group": { "events": "14", "n": "97" }, "Control group": { "events": "27", "n": "98" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Low-dose group": { "hallucination": "2", "dizziness": "7", "visual": "2" }, "High-dose group": { "hallucination": "9", "dizziness": "7", "visual": "9" }, "Control group": { "hallucination": "0", "dizziness": "2", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-01", "end": "2023-01" }, "registration": null, "note": "The source calls the high-dose arm 'How-dose group' (a typo for High-dose). Per-arm randomized numbers are not printed: 315 were enrolled, with '8 lost to follow-up in Low-dose group and high-dose group, and 7 in control group', leaving 97, 97 and 98 analysed (315 - 292 = 23 suggests 8 lost in each dose group, so 105 per arm, but that is not printed and randomized is left null); the tables' column n's are used for every entry. EPDS 'Prenatal 1 day' (Methods: preoperative day 1) coded as day -1. Table 4 counts are postpartum depression, defined in Methods as EPDS ≥ 13, so they count participants with depression and sit under the design's 'EPDS' beside the Table 3 means, told apart by form. The rescue rate is 'the rate of rescue analgesia within the first 2 days postoperatively', coded as day 2. VAS at 6 h and 12 h not coded. Adverse events from Table 7, window '0-2 h' (Results: within 2 hours after the esketamine injection, which was given after delivery during caesarean; Methods: 0–2 hours postoperatively), coded postoperative; diplopia coded as visual. In Table 7 the low-dose percentages do not match the counts (hallucination '2 (7.2)', diplopia '2 (8)', drowsiness '6 (10.3)' with n = 97); counts copied as printed. Adverse events at 2.1–48 h are reported only as not significantly different. Enrollment dates from Methods (Results give none). No registration number given (only IRB protocol 20200060).", "decided_by": "third reader" }, { "trial": "T058", "source": "fulltext", "arms": { "Group S": { "randomized": null, "analysed": "42" }, "Group C": { "randomized": null, "analysed": "43" } }, "depression": [ { "measure": "Geriatric Depression Scale (GDS-15)", "day": -1, "form": "mean_sd", "location": "Table 1", "values": { "Group S": { "mean": "4.6", "sd": "1.8", "n": "42" }, "Group C": { "mean": "4.6", "sd": "2.0", "n": "43" } } }, { "measure": "Geriatric Depression Scale (GDS-15)", "day": 2, "form": "mean_sd", "location": "Table 2", "values": { "Group S": { "mean": "3.7", "sd": "1.6", "n": "42" }, "Group C": { "mean": "4.7", "sd": "1.6", "n": "43" } } }, { "measure": "Geriatric Depression Scale (GDS-15)", "day": 2, "form": "count", "definition": "GDS-15 >= 5", "location": "Table 2", "values": { "Group S": { "events": "12", "n": "42" }, "Group C": { "events": "23", "n": "43" } } }, { "measure": "Geriatric Depression Scale (GDS-15)", "day": 7, "form": "mean_sd", "location": "Table 2", "values": { "Group S": { "mean": "3.5", "sd": "1.8", "n": "42" }, "Group C": { "mean": "4.3", "sd": "1.7", "n": "43" } } }, { "measure": "Geriatric Depression Scale (GDS-15)", "day": 7, "form": "count", "definition": "GDS-15 >= 5", "location": "Table 2", "values": { "Group S": { "events": "15", "n": "42" }, "Group C": { "events": "21", "n": "43" } } }, { "measure": "Geriatric Depression Scale (GDS-15)", "day": 30, "form": "mean_sd", "location": "Table 2", "values": { "Group S": { "mean": "3.4", "sd": "1.5", "n": "41" }, "Group C": { "mean": "3.3", "sd": "1.6", "n": "41" } } }, { "measure": "Geriatric Depression Scale (GDS-15)", "day": 30, "form": "count", "definition": "GDS-15 >= 5", "location": "Table 2", "values": { "Group S": { "events": "10", "n": "41" }, "Group C": { "events": "9", "n": "41" } } } ], "pain": [ { "measure": "worst pain VAS", "day": 1, "form": "median_iqr", "location": "Table 3", "values": { "Group S": { "median": "2", "q1": "1", "q3": "3", "n": "42" }, "Group C": { "median": "2", "q1": "1", "q3": "3", "n": "43" } } }, { "measure": "worst pain VAS", "day": 2, "form": "median_iqr", "location": "Table 3", "values": { "Group S": { "median": "1", "q1": "0.75", "q3": "2", "n": "42" }, "Group C": { "median": "2", "q1": "1", "q3": "3", "n": "43" } } }, { "measure": "effective PCIA presses", "day": 2, "form": "median_iqr", "location": "Table 3 (no time stated; the PCIA ran 48 h)", "values": { "Group S": { "median": "1", "q1": "0", "q3": "2", "n": "42" }, "Group C": { "median": "2", "q1": "1", "q3": "4", "n": "43" } } }, { "measure": "sufentanil consumption", "day": 2, "form": "mean_sd", "location": "Table 3 (no time stated; the PCIA ran 48 h)", "values": { "Group S": { "mean": "89.9", "sd": "17.9", "n": "42" }, "Group C": { "mean": "89.7", "sd": "15.9", "n": "43" } } } ], "adverse_events": [ { "window": "overall", "location": "Table 5", "values": { "Group S": { "hallucination": "2", "dizziness": "5", "nightmare": "6" }, "Group C": { "hallucination": "3", "dizziness": "3", "nightmare": "5" } } } ], "blinding_check": null, "enrollment": { "start": "2022-07", "end": "2023-08" }, "registration": { "number": "ChiCTR2200061956", "date": null }, "note": "90 were randomized in total; per-arm numbers are not printed (Fig. 1 not in text). Analysed 43 (C) and 42 (S); 2 (C) and 1 (S) were lost by day 30, hence 41/41 then. Day-2 GDS-15: the text prints '3.7 +/- 1.63 vs. 4.7 +/- 1.62, P = 0.07', Table 2 prints 3.7 +/- 1.6 vs 4.7 +/- 1.6, P 0.007; the table is taken. Table 3's VAS row is labelled only 'VAS, median (IQR)'; Methods name the outcome 'the worst pain score'. Effective presses and sufentanil consumption carry no time in Table 3; they are put at day 2 because the PCIA (the only sufentanil after surgery) ran 48 h; drop them if a stated window is required. Adverse events have no stated window (the study drug was given only in the 48-h postoperative PCIA). In Table 5 the Nightmares and Pruritus rows are identical (5 (11.9) vs 6 (14.3)), and 5 of 43 would be 11.6%.", "decided_by": "both coders" }, { "trial": "T059", "source": "fulltext", "arms": { "Treatment Arm": { "randomized": "30", "analysed": "28" }, "Control Arm (saline)": { "randomized": "30", "analysed": "27" } }, "depression": [ { "measure": "Self-rating Depression Scale (SDS), at admission and discharge", "day": 28, "form": "median_iqr", "location": "Table 3, 'Median SDS on Day 28 (Q25, Q75)'", "values": { "Treatment Arm": { "median": "49.8", "q1": "43.1", "q3": "56.5", "n": "28" }, "Control Arm (saline)": { "median": "53.1", "q1": "47.3", "q3": "59.0", "n": "27" } } } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2020-09", "end": "2022-12" }, "registration": { "number": "ChiCTR2000034069", "date": "2020-06-22" }, "note": "60 randomized (30/30); 3 withdrew consent and 2 were excluded for continuous sedation in ICU (arms not stated); analysed 28/27 from the table headers (modified ITT). Methods say SDS was taken on admission and at discharge, but only 'Median SDS on Day 28' is printed (Table 3); admission SDS is not reported. The trial counts days from admission (Day 0); esketamine was given at induction of each of the first 3 surgeries, held at unstated days during the first month after injury, and in the analgesic pump for up to 7 postoperative days, so Day 28 after admission is not a known number of days after the procedure (at most 28 after the first surgery); day is entered as printed (28). The Table 3 'Median (Q25, Q75)' values for SDS, PCL-C and PSQI sit almost symmetrically around the centre (SDS 49.8 (43.1, 56.5) and 53.1 (47.3, 59.0)), which may mean another summary was mislabelled; recorded as printed. Postoperative NPRr and NPRm are only in Fig. 2 (medians with IQR bars, no printed values). Left out as not at 24 or 48 h (Table 2, whole postoperative period, Treatment vs Control): cases with NPRr > 3, 3 (10.7 %) vs 6 (22.2 %); NPRm > 3, 9 (32.1 %) vs 17 (65.4 %); postoperative daily opioid consumption (IV morphine equivalents, mg) 26.0 (16.3, 32.5) vs 35.0 (26.4, 50.9); SAE grade 1-2 on day 28 after admission or at discharge 19 (67.9 %) vs 11 (40.7 %). No psychotomimetic adverse events reported.", "decided_by": "third reader" }, { "trial": "T060", "source": "fulltext", "arms": { "Morning operation with esketamine": { "randomized": "108", "analysed": "107" }, "Morning operation with saline": { "randomized": "108", "analysed": "105" }, "Afternoon operation with esketamine": { "randomized": "108", "analysed": "106" }, "Afternoon operation with saline": { "randomized": "108", "analysed": "108" } }, "depression": [ { "measure": "Hospital Anxiety and Depression Scale (HAD)", "day": -1, "form": "median_iqr", "location": "Table 3 (Preoperation)", "values": { "Morning operation with esketamine": { "median": "4", "q1": "3", "q3": "6", "n": "108" }, "Morning operation with saline": { "median": "5", "q1": "3", "q3": "7", "n": "108" }, "Afternoon operation with esketamine": { "median": "4", "q1": "2", "q3": "6", "n": "108" }, "Afternoon operation with saline": { "median": "4", "q1": "3", "q3": "6", "n": "108" } } }, { "measure": "Hospital Anxiety and Depression Scale (HAD)", "day": 1, "form": "median_iqr", "location": "Table 3 (Postoperative day 1)", "values": { "Morning operation with esketamine": { "median": "8", "q1": "7", "q3": "10", "n": "107" }, "Morning operation with saline": { "median": "8", "q1": "7", "q3": "10", "n": "105" }, "Afternoon operation with esketamine": { "median": "8", "q1": "6", "q3": "10", "n": "106" }, "Afternoon operation with saline": { "median": "8", "q1": "6", "q3": "10", "n": "108" } } }, { "measure": "Hospital Anxiety and Depression Scale (HAD)", "day": 3, "form": "median_iqr", "location": "Table 3 (Postoperative day 3)", "values": { "Morning operation with esketamine": { "median": "8", "q1": "6", "q3": "10", "n": "107" }, "Morning operation with saline": { "median": "8", "q1": "6", "q3": "9", "n": "105" }, "Afternoon operation with esketamine": { "median": "7", "q1": "6", "q3": "9", "n": "106" }, "Afternoon operation with saline": { "median": "8", "q1": "6", "q3": "10", "n": "108" } } }, { "measure": "Hospital Anxiety and Depression Scale (HAD)", "day": 7, "form": "median_iqr", "location": "Table 3 (Postoperative day 7)", "values": { "Morning operation with esketamine": { "median": "7", "q1": "6", "q3": "9", "n": "107" }, "Morning operation with saline": { "median": "7", "q1": "5", "q3": "9", "n": "105" }, "Afternoon operation with esketamine": { "median": "7", "q1": "5", "q3": "9", "n": "106" }, "Afternoon operation with saline": { "median": "7", "q1": "5", "q3": "9", "n": "108" } } } ], "pain": [ { "measure": "postoperative NRS", "day": 1, "form": "median_iqr", "location": "Table 6 (Postoperative day 1)", "values": { "Morning operation with esketamine": { "median": "2", "q1": "1", "q3": "3", "n": "107" }, "Morning operation with saline": { "median": "2", "q1": "1", "q3": "3", "n": "105" }, "Afternoon operation with esketamine": { "median": "2", "q1": "1", "q3": "3", "n": "106" }, "Afternoon operation with saline": { "median": "2", "q1": "1", "q3": "3", "n": "108" } } }, { "measure": "postoperative NRS", "day": 2, "form": "median_iqr", "location": "Table 6 (Postoperative day 2)", "values": { "Morning operation with esketamine": { "median": "2", "q1": "1", "q3": "3", "n": "107" }, "Morning operation with saline": { "median": "2", "q1": "1", "q3": "3", "n": "105" }, "Afternoon operation with esketamine": { "median": "2", "q1": "1", "q3": "3", "n": "106" }, "Afternoon operation with saline": { "median": "3", "q1": "1", "q3": "4", "n": "108" } } } ], "adverse_events": [ { "window": "emergence", "location": "Table 9 (PACU rows)", "values": { "Morning operation with esketamine": { "agitation": "19", "dizziness": "33" }, "Morning operation with saline": { "agitation": "31", "dizziness": "24" }, "Afternoon operation with esketamine": { "agitation": "18", "dizziness": "21" }, "Afternoon operation with saline": { "agitation": "28", "dizziness": "18" } } }, { "window": "postoperative", "location": "Table 9 (Postoperation rows)", "values": { "Morning operation with esketamine": { "dizziness": "34" }, "Morning operation with saline": { "dizziness": "46" }, "Afternoon operation with esketamine": { "dizziness": "42" }, "Afternoon operation with saline": { "dizziness": "40" } } } ], "blinding_check": null, "enrollment": { "start": "2022-01-04", "end": "2023-03-07" }, "registration": null, "note": "2x2 factorial (operation time x esketamine 0.2 mg/kg single dose before induction). Tables abbreviate the arms: AES = Afternoon operation with esketamine, ANS = Afternoon operation with saline, MES = Morning operation with esketamine, MNS = Morning operation with saline. 432 randomized 1:1:1:1 (Results); the text prints no other per-arm count of those randomized (Fig. 1's values are not shown), so randomized is the n Table 3 prints for every arm at the preoperative visit, 108, which sums to the 432 randomized. Analysed 426: AES 106, ANS 108, MES 107, MNS 105 (Tables 1, 3, 6, 8, 9); patients whose operation was canceled were excluded. 'HAD' scores are copied as the paper reports them (a single HAD score, no subscales). The first postoperative follow-up came at least 20 h after morning and 14 h after afternoon operations (Methods), so the afternoon arms' 'postoperative day 1' may be under 24 h; coded by the day the source names. GEE estimates (esketamine vs saline: B = -0.054 for HAD, -0.010 for NRS) not entered. PACU rows of Table 9 coded as emergence (EA = emergence agitation coded as agitation); 'Postoperation' rows as postoperative; intraoperative rows (injection pain, cough, hypotension, hypertension, SpO2 < 95%) hold no psychotomimetic category; postoperative delirium (3D-CAM, the primary outcome) is not entered as an adverse event. Enrollment dates are from Methods ('enrolled between 4 January 2022 and 7 March 2023'). No trial registration number appears in the text (ethics approval WDRY2021-K124, 18 August 2021).", "decided_by": "third reader" }, { "trial": "T061", "source": "fulltext", "arms": { "Group E": { "randomized": "79", "analysed": "78" }, "Group C": { "randomized": "79", "analysed": "77" } }, "depression": [ { "measure": "HADS depression subscale (HADS-D)", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Group E": { "median": "1", "q1": "0", "q3": "3", "n": "78" }, "Group C": { "median": "2", "q1": "0", "q3": "4", "n": "77" } } }, { "measure": "HADS depression subscale (HADS-D)", "day": 3, "form": "median_iqr", "location": "Table 2", "values": { "Group E": { "median": "1", "q1": "0", "q3": "4", "n": "78" }, "Group C": { "median": "1", "q1": "0", "q3": "3", "n": "77" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 4", "values": { "Group E": { "nightmare": "2" }, "Group C": { "nightmare": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-12-31", "end": "2024-03-31", "location": "Results ('Between December 31, 2023, and March 31, 2024, 169 patients were assessed for eligibility'); the Methods say December 30, 2023 to March 30, 2024" }, "registration": { "number": "ChiCTR2400080363", "date": null }, "note": "Group E = esketamine 0.3 then 0.15 mg/kg/h from induction, stopped 30 min before the end of surgery; Group C = saline. 158 randomized, 79 per group; 3 excluded for changing to general anesthesia; analysed 78 (E) and 77 (C). HADS-D printed as median (p25, p75), preoperative (day -1) and POD 3. Nightmare (E 2 (2.6%), C 0 (0%)) sits in Table 4 under the heading 'Intraoperative complications', but the Methods list nightmares among postoperative complications and the text names them with the postoperative events, so the window is recorded as postoperative. No pain scores at 24 or 48 h (only intraoperative opioid doses); no other psychotomimetic events reported.", "decided_by": "both coders" }, { "trial": "T062", "source": "library", "arms": { "Group S": { "randomized": null, "analysed": "33" }, "Group C (0.9% saline)": { "randomized": null, "analysed": "32" } }, "depression": [], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 3", "values": { "Group S": { "dizziness": "3", "hallucination": "2", "any_ae": "12" }, "Group C (0.9% saline)": { "dizziness": "2", "hallucination": "0", "any_ae": "10" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR2300070728", "date": null }, "note": "Per-arm randomized numbers are not given. The text says 72 were randomized and 4 were then excluded, yet 65 were analysed (33/32); the abstract pairs '72 ... enrolled' with n = 33 and 32. PHQ-9 at baseline, 1 week and 3 months is shown only in Figure 4, with no printed values. NRS at 4 h and 24 h (rest and movement) is only in Figures 2-3. CPSP at 3 months (Table 2: 6(18.2%) vs 14(43.8%); the abstract gives 48.3% for group C) falls outside the day 1-2 window and is not entered. Rescue hydromorphone appears only as Table 1's 'Rescue analgesic (N, %)', 6(18%) vs 13(41%), with no time window, so it is not entered as day 1 or 2. Table 3's adverse-event window is not stated beyond 'postoperative nausea and vomiting' (patients were under general anaesthesia), so it is entered as postoperative. 'Dizzy(n)' is entered as dizziness and 'Total(n)' as any_ae (PONV, the other row, is not a codebook category). Registration is stated as 'before patient enrollment', with no date. No enrollment dates are given.", "decided_by": "both coders" }, { "trial": "T063", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "182", "analysed": "182" }, "Placebo (saline) group": { "randomized": "182", "analysed": "182" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 1 (Median (IQR) Edinburgh postnatal depression scale)", "values": { "Esketamine group": { "median": "10", "q1": "10", "q3": "12", "n": "182" }, "Placebo (saline) group": { "median": "10", "q1": "10", "q3": "12", "n": "182" } } }, { "measure": "MINI 6.0.0 depression module (major depressive episode)", "day": 42, "form": "count", "definition": "major depressive episode diagnosed with the MINI 6.0.0", "location": "Table 3 (primary endpoint); denominators from Results, Efficacy outcomes", "values": { "Esketamine group": { "events": "12", "n": "180" }, "Placebo (saline) group": { "events": "46", "n": "181" } } }, { "measure": "EPDS", "day": 7, "form": "median_iqr", "location": "Table 3 (Median (IQR) EPDS score at 7 days)", "values": { "Esketamine group": { "median": "5", "q1": "2", "q3": "8", "n": null }, "Placebo (saline) group": { "median": "9", "q1": "5", "q3": "11", "n": null } } }, { "measure": "EPDS", "day": 42, "form": "median_iqr", "location": "Table 3 (Median (IQR) EPDS score at 42 days)", "values": { "Esketamine group": { "median": "5", "q1": "3", "q3": "8", "n": null }, "Placebo (saline) group": { "median": "8", "q1": "5", "q3": "11", "n": null } } }, { "measure": "HAMD-17", "day": 42, "form": "median_iqr", "location": "Table 3 (Median (IQR) Hamilton depression rating scale score at 42 days)", "values": { "Esketamine group": { "median": "5", "q1": "2", "q3": "8", "n": null }, "Placebo (saline) group": { "median": "10", "q1": "5", "q3": "17", "n": null } } } ], "pain": [ { "measure": "NRS pain", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS for pain at 1 day, at rest)", "values": { "Esketamine group": { "median": "2", "q1": "1", "q3": "3", "n": "182" }, "Placebo (saline) group": { "median": "2", "q1": "1", "q3": "3", "n": null } } }, { "measure": "NRS pain", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS for pain at 1 day, with movement)", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "5", "n": "182" }, "Placebo (saline) group": { "median": "4", "q1": "3", "q3": "6", "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "values": { "Esketamine group": { "dizziness": "48", "visual": "9", "hallucination": "6", "agitation": "6" }, "Placebo (saline) group": { "dizziness": "17", "visual": "0", "hallucination": "0", "agitation": "5" } } }, { "window": "postoperative", "values": { "Esketamine group": { "dizziness": "32", "visual": "4", "hallucination": "3" }, "Placebo (saline) group": { "dizziness": "24", "visual": "0", "hallucination": "0" } } }, { "window": "overall", "values": { "Esketamine group": { "psychiatric_any": "82" }, "Placebo (saline) group": { "psychiatric_any": "40" } } } ], "blinding_check": null, "enrollment": { "start": "2020-06-19", "end": "2022-06-21" }, "registration": null, "note": "All 364 randomized (182 per arm) were in the intention-to-treat analysis; 2 esketamine and 1 placebo participants withdrew consent (per protocol 361). Table 3's columns are n = 182 and it prints, in parentheses marked ‡, the number of participants with missing data, not n: EPDS 7 d 1 and 1; EPDS 42 d 2 and 1; HAMD-17 42 d 33 and 28 (esketamine, placebo), so n is null there. NRS at 1 day, at rest and with movement, has no ‡ for esketamine (n is the column's 182) and (1)‡ for placebo (n null). Major depressive episode n from the text (6.7% (12/180) vs 25.4% (46/181)), RR 0.26 (0.14 to 0.48); with missing data imputed (worst case for esketamine) 14 (7.7) vs 46 (25.3) of 182, RR 0.30 (0.17 to 0.53), not coded. Table 3 median differences (esketamine minus placebo, Hodges-Lehmann): EPDS 7 d −3 (−4 to −2); EPDS 42 d −3 (−4 to −2); HAMD-17 −4 (−6 to −3); NRS at rest and with movement −1 (−1 to 0). Exploratory counts (EPDS ≤ 9 at 7 d 153 vs 103 and at 42 d 151 vs 106, EPDS reductions ≥ 4 and ≥ 50%, HAMD-17 ≤ 7 106 vs 60) count non-depressed or improved participants and are not coded. Pain at 1 day (interview 18 to 30 h after childbirth) has two NRS pain entries with the same measure, day and form, at rest first and then with movement, told apart by location. Adverse events (Table 4): window 1 is 'during and within 1 hour after study drug infusion' (a 40-minute infusion started after cord clamping, vaginal or caesarean birth), coded intraoperative; window 2 is 'at 2 hours after study drug infusion', coded postoperative; 'Hallucination or daymare' (merged by the authors) coded as hallucination, though the text says five mothers reported hallucinations during and within an hour after infusion; diplopia coded as visual; agitation is RASS ≥ 2. The combined neuropsychiatric rows of Table 4 (61 vs 20; 37 vs 24) are not coded because their parts are. The overall incidence of neuropsychiatric adverse events (text: 45.1% (82/182) vs 22.0% (40/182)) includes dizziness and is coded psychiatric_any with window overall; the text also says no neuropsychiatric symptoms were observed on postpartum day 1. Enrollment dates are the screening period in Results; the last participant was followed up on 3 August 2022. No registration number in the text.", "decided_by": "third reader" }, { "trial": "T064", "source": "fulltext", "arms": { "Ketamine": { "randomized": "152", "analysed": "129" }, "Placebo (0.9% saline)": { "randomized": "149", "analysed": "132" } }, "depression": [ { "measure": "HADS depression score (>= 8)", "day": -1, "form": "count", "definition": "HADS Depression score of 8 or above", "location": "Table 1, 'Symptoms of depression (HADS Depression score of 8 or above)', denominators from footnote ††", "values": { "Ketamine": { "events": "21", "n": "136" }, "Placebo (0.9% saline)": { "events": "28", "n": "132" } } }, { "measure": "HADS depression score (>= 8)", "day": 7, "form": "count", "definition": "HADS Depression score of 8 or above", "location": "Table 2, 'Seven days following surgery: Symptoms of depression', denominators from footnote ***", "values": { "Ketamine": { "events": "19", "n": "124" }, "Placebo (0.9% saline)": { "events": "27", "n": "128" } } }, { "measure": "HADS depression score (>= 8)", "day": 90, "form": "count", "definition": "HADS Depression score of 8 or above", "location": "Table 2, 'Ninety days following surgery: Symptoms of depression', denominators from footnote ††", "values": { "Ketamine": { "events": "11", "n": "124" }, "Placebo (0.9% saline)": { "events": "24", "n": "113" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "Ketamine": { "psychiatric_any": "4" }, "Placebo (0.9% saline)": { "psychiatric_any": "5" } } }, { "window": "overall", "values": { "Ketamine": { "any_ae": "33" }, "Placebo (0.9% saline)": { "any_ae": "34" } } } ], "blinding_check": null, "enrollment": { "start": "2017-03-20", "end": "2019-05-28" }, "registration": { "number": "NCT02892916", "date": "September 2016" }, "note": "Randomized 152 ketamine / 149 placebo (abstract); 9 withdrew consent, ITT 149/143 (Results, Table 1 and Table 2 column heads); 'All analyses were performed on a modified intention-to-treat (mITT) basis', mITT 129/132, recorded as analysed. Depression is reported only as counts with HADS-D >= 8; n per time is the table footnote denominator (Table 2's 90-day column heads say n = 125/115, but footnote †† gives 124/113, which matches the printed percentages). Table 2 ORs (adjusted for MoCA, age and baseline): day 7 0.71 [0.30-1.70], day 90 0.34 [0.13-0.86]. Three months coded as day 90 (Table 2 says 'Ninety days following surgery'). Pain (VAS at rest, cumulative opioids, DN4) is reported only in supplementary Tables S6-S7, not in this text; the text says only that pain at rest was lower in PACU with ketamine. Adverse events: 'postoperative psychiatric adverse events during the initial seven days' 4 (2.68%) of 149 vs 5 (3.5%) of 143 (Methods: hallucinations collected, nightmares not), coded psychiatric_any; 'perioperative adverse events' 33 [23.1%] ketamine vs 34 [23.4%] placebo coded any_ae with window overall (their percentages do not match the ITT denominators). Delirium (CAM) 6 (4.14%) vs 9 (6.34%) over 7 days not coded as agitation. Primary outcome changed by amendment on 02/19/2018 (93 enrolled), registered May 2019; IRB reference '#2016-000691-16'.", "decided_by": "both coders" }, { "trial": "T065", "source": "fulltext", "arms": { "Esketamine group (Group E)": { "randomized": "32", "analysed": "32" }, "Control group (Group C)": { "randomized": "32", "analysed": "32" } }, "depression": [ { "measure": "PHQ-9", "day": -1, "form": "mean_sd", "location": "Table 3", "values": { "Esketamine group (Group E)": { "mean": "3.22", "sd": "3.44", "n": null }, "Control group (Group C)": { "mean": "3.28", "sd": "3.15", "n": null } } }, { "measure": "PHQ-9", "day": 1, "form": "mean_sd", "location": "Table 3", "values": { "Esketamine group (Group E)": { "mean": "2.19", "sd": "2.75", "n": null }, "Control group (Group C)": { "mean": "4.03", "sd": "3.84", "n": null } } }, { "measure": "PHQ-9", "day": 3, "form": "mean_sd", "location": "Table 3", "values": { "Esketamine group (Group E)": { "mean": "2.56", "sd": "3.27", "n": null }, "Control group (Group C)": { "mean": "3.25", "sd": "2.71", "n": null } } }, { "measure": "PHQ-9", "day": 7, "form": "mean_sd", "location": "Table 3", "values": { "Esketamine group (Group E)": { "mean": "1.91", "sd": "2.26", "n": null }, "Control group (Group C)": { "mean": "3.16", "sd": "2.94", "n": null } } }, { "measure": "PHQ-9", "day": 30, "form": "mean_sd", "location": "Table 3", "values": { "Esketamine group (Group E)": { "mean": "1.72", "sd": "2.05", "n": null }, "Control group (Group C)": { "mean": "2.44", "sd": "2.94", "n": null } } } ], "pain": [ { "measure": "VAS pain score", "day": 1, "form": "mean_sd", "location": "Table 3", "values": { "Esketamine group (Group E)": { "mean": "1.28", "sd": "1.97", "n": null }, "Control group (Group C)": { "mean": "1.22", "sd": "1.70", "n": null } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2022-05", "end": "2023-03" }, "registration": null, "note": "Table 3 prints mean ± SD (Methods: quantitative data as mean ± SD; Figures 4 and 5 plot mean and SE), so coded mean_sd. Table 3 gives no n; 32 per group were analysed and the Results say no one missed follow-up. 'Before' coded as baseline. Pain: only the POD 1 VAS falls on the pain days (POD 3, 7, 30 left out); the design's opioid measure, intraoperative remifentanil (Table 2), is day 0 and left out. Complications (Table 2) were nausea, vomiting and delirium (0 vs 0), none in the adverse-event categories. Enrollment is from Methods (patients operated May 2022 to March 2023). No registration in the text.", "decided_by": "both coders" }, { "trial": "T066", "source": "fulltext", "arms": { "Esketamine group (Group E)": { "randomized": null, "analysed": "39" }, "Normal saline placebo group (Group C)": { "randomized": null, "analysed": "40" } }, "depression": [], "pain": [ { "measure": "NRS pain (1, 2, 6, 12, 24, 48 h after surgery)", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group (Group E)": { "median": "2", "q1": "1", "q3": "3", "n": "39" }, "Normal saline placebo group (Group C)": { "median": "2", "q1": "1", "q3": "3", "n": "40" } } }, { "measure": "NRS pain (1, 2, 6, 12, 24, 48 h after surgery)", "day": 2, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group (Group E)": { "median": "2", "q1": "1", "q3": "3", "n": "39" }, "Normal saline placebo group (Group C)": { "median": "1.5", "q1": "1", "q3": "2", "n": "40" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2021-04", "end": "2022-05" }, "registration": { "number": "ChiCTR2100043935", "date": "2021-03-05" }, "note": "SDS (the design's depression measure, POD2) appears only in Figure 3 with no printed values; the text says only that groups L and E scored lower than C (P < 0.05), so no depression entries. Randomized per arm is in Figure 1 (not printed); 137 were assessed for eligibility and Tables 1 to 3 give the analysed n (C 40, E 39). Remifentanil consumption (Table 3) is intraoperative, outside days 1 and 2, and postoperative tramadol rescue is not reported. The text says 'There were no indications of lidocaine toxicity or esketamine side effects among any participants' without naming categories, so no AE entries (PONV 12 vs 4 is not a codebook category). Lidocaine group (role other) not extracted. Enrollment from Methods ('between April 2021 and May 2022'); the Results give no dates.", "decided_by": "both coders" }, { "trial": "T067", "source": "fulltext", "arms": { "Control group (placebo)": { "randomized": "45", "analysed": "42" }, "Low esketamine group (0.2 mg/kg)": { "randomized": "45", "analysed": "42" }, "High esketamine group (0.5 mg/kg)": { "randomized": "45", "analysed": "45" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "count", "definition": "HADS-D ≥ 8", "location": "Table 3, Depression incidence, Preoperative", "values": { "Control group (placebo)": { "events": "15", "n": "42" }, "Low esketamine group (0.2 mg/kg)": { "events": "20", "n": "42" }, "High esketamine group (0.5 mg/kg)": { "events": "16", "n": "45" } } }, { "measure": "HADS-D", "day": 1, "form": "count", "definition": "HADS-D ≥ 8", "location": "Table 3, Depression incidence, POD1", "values": { "Control group (placebo)": { "events": "12", "n": "42" }, "Low esketamine group (0.2 mg/kg)": { "events": "5", "n": "42" }, "High esketamine group (0.5 mg/kg)": { "events": "1", "n": "45" } } }, { "measure": "HADS-D", "day": 3, "form": "count", "definition": "HADS-D ≥ 8", "location": "Table 3, Depression incidence, POD3", "values": { "Control group (placebo)": { "events": "2", "n": "42" }, "Low esketamine group (0.2 mg/kg)": { "events": "0", "n": "42" }, "High esketamine group (0.5 mg/kg)": { "events": "1", "n": "45" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 2, 'Postoperative Agitation'", "values": { "Control group (placebo)": { "agitation": "3" }, "Low esketamine group (0.2 mg/kg)": { "agitation": "5" }, "High esketamine group (0.5 mg/kg)": { "agitation": "2" } } }, { "window": "overall", "location": "Results 3.6 Side effects (text: no participants reported)", "values": { "Control group (placebo)": { "hallucination": "0", "nightmare": "0", "dizziness": "0" }, "Low esketamine group (0.2 mg/kg)": { "hallucination": "0", "nightmare": "0", "dizziness": "0" }, "High esketamine group (0.5 mg/kg)": { "hallucination": "0", "nightmare": "0", "dizziness": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-06", "end": "2022-07" }, "registration": { "number": "ChiCTR2100047067", "date": null }, "note": "Depression entries are Table 3 counts of depressive symptoms, HADS-D of 8 or more; POD-1 (the day before surgery) is day -1. Continuous HADS-D and the pain VAS at 2, 24, 48 and 72 h are only in Fig. 3 (no printed values), so no pain entries. 135 randomized (45 per arm); six lost (withdrawal of consent or no follow-up): analysed 42/42/45. Postoperative agitation (Table 2) is printed as counts without percentages. Results 3.6 says no participants reported nightmares, dizziness, itching, urinary retention, convulsions or hallucinations, with no window stated; entered as 0 in every arm in a separate entry coded overall (esketamine was given under general anaesthesia, and follow-up ran to POD3).", "decided_by": "third reader" }, { "trial": "T069", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "150", "analysed": "148" }, "Control group": { "randomized": "150", "analysed": "150" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": -1, "form": "mean_sd", "location": "Table (Baseline EPDS score, mean (SD)); same in Results text", "values": { "Esketamine group": { "mean": "4.2", "sd": "2.3", "n": "148" }, "Control group": { "mean": "4.0", "sd": "2.2", "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, Efficacy Outcomes", "values": { "Esketamine group": { "events": "34", "n": "148" }, "Control group": { "events": "53", "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "change_difference", "location": "Results, Efficacy Outcomes", "estimate": "-1.17", "se": "0.44", "lower": "-2.04", "upper": "-0.31", "level": "0.95", "scale": "mean_difference", "contrast": "Esketamine group minus Control group", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } }, "contrast_sign": "ketamine_minus_control" }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, Efficacy Outcomes", "values": { "Esketamine group": { "events": "46", "n": "148" }, "Control group": { "events": "57", "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "change_difference", "location": "Results, Efficacy Outcomes", "estimate": "0.32", "se": "0.49", "lower": "-0.63", "upper": "1.28", "level": "0.95", "scale": "mean_difference", "contrast": "Esketamine group minus Control group", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } }, "contrast_sign": "ketamine_minus_control" }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 28, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, Efficacy Outcomes", "values": { "Esketamine group": { "events": "53", "n": "148" }, "Control group": { "events": "55", "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 28, "form": "change_difference", "location": "Results, Efficacy Outcomes", "estimate": "0.24", "se": "0.52", "lower": "-0.78", "upper": "1.26", "level": "0.95", "scale": "mean_difference", "contrast": "Esketamine group minus Control group", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } }, "contrast_sign": "ketamine_minus_control" }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 42, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, Efficacy Outcomes", "values": { "Esketamine group": { "events": "50", "n": "148" }, "Control group": { "events": "56", "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 42, "form": "change_difference", "location": "Results, Efficacy Outcomes", "estimate": "-0.06", "se": "0.49", "lower": "-1.03", "upper": "0.91", "level": "0.95", "scale": "mean_difference", "contrast": "Esketamine group minus Control group", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } }, "contrast_sign": "ketamine_minus_control" } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2022-01-01", "end": "2023-01-01" }, "registration": { "number": "ChiCTR2100054199", "date": null }, "note": "After baseline, continuous EPDS is reported only as least-squares mean differences in change from baseline (MMRM with baseline EPDS as a covariate), entered as change_difference with the printed SE. The direction (esketamine minus control) is inferred from the text ('a significant decrease ... in the esketamine group compared with the control group'). Per-arm post-baseline EPDS means are in eTable 2, which is not in the source. Day 7 also reports an odds ratio of 0.55 (95% CI 0.33-0.91) and 'effect size, 0.74'. PPD is EPDS ≥ 10 (Methods and the Table's footnote). The source prints minus signs as − and, at day 42, –; both are entered as ASCII '-'. NRS pain is in eTable 3 and Figure 4 only, except movement NRS at 72 h (median 3.0 [IQR 2.0-3.0] vs 3.0 [3.0-3.5]), which falls outside the day 1-2 window. Adverse events are in eTable 5 only, with no counts in the text. Randomized: '150 each were enrolled and randomly assigned'; 2 esketamine patients refused follow-up at postpartum day 5. Enrollment dates are the Results' (assessed for eligibility between these dates); the Methods give the same.", "decided_by": "both coders" }, { "trial": "T070", "source": "fulltext", "arms": { "Esketamine group": { "randomized": null, "analysed": "40" }, "Control group": { "randomized": null, "analysed": "40" } }, "depression": [ { "measure": "PHQ-9", "day": -1, "form": "count", "definition": "PHQ-9 score ≥ 5", "location": "Table 1 (Depression, n (%))", "values": { "Esketamine group": { "events": "2", "n": "40" }, "Control group": { "events": "0", "n": "40" } } }, { "measure": "PHQ-9", "day": 1, "form": "count", "definition": "PHQ-9 score ≥ 5", "location": "Table 2 (Depression POD1)", "values": { "Esketamine group": { "events": "1", "n": "40" }, "Control group": { "events": "3", "n": "40" } } }, { "measure": "PHQ-9", "day": 2, "form": "count", "definition": "PHQ-9 score ≥ 5", "location": "Table 2 (Depression POD2)", "values": { "Esketamine group": { "events": "1", "n": "40" }, "Control group": { "events": "6", "n": "40" } } } ], "pain": [ { "measure": "VAS pain score", "day": 1, "form": "mean_sd", "location": "Table 2, VAS at T2 (postoperative day 1 morning, 8:00-10:00 a.m.)", "values": { "Esketamine group": { "mean": "2.55", "sd": "1.02", "n": "40" }, "Control group": { "mean": "2.75", "sd": "0.75", "n": "40" } } }, { "measure": "VAS pain score", "day": 1, "form": "mean_sd", "location": "Table 2, VAS at T3 (postoperative day 1 afternoon, 3:00-5:00 p.m.)", "values": { "Esketamine group": { "mean": "2.58", "sd": "0.82", "n": "40" }, "Control group": { "mean": "2.89", "sd": "0.65", "n": "40" } } }, { "measure": "VAS pain score", "day": 2, "form": "mean_sd", "location": "Table 2, VAS at T4 (postoperative day 2 morning)", "values": { "Esketamine group": { "mean": "2.66", "sd": "0.68", "n": "40" }, "Control group": { "mean": "3.14", "sd": "0.70", "n": "40" } } }, { "measure": "VAS pain score", "day": 2, "form": "mean_sd", "location": "Table 2, VAS at T5 (postoperative day 2 afternoon)", "values": { "Esketamine group": { "mean": "2.58", "sd": "0.83", "n": "40" }, "Control group": { "mean": "3.16", "sd": "0.67", "n": "40" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2022-07-07", "end": "2023-02-20" }, "registration": null, "note": "Esketamine was given only in the postoperative PCIA (with sufentanil) for 24 h. Per-arm randomized numbers are not printed (Fig. 1 values not shown); the final analysis (stated as intention-to-treat) included 40 per group, the planned sample size. Depression is reported only as counts of PHQ-9 >= 5, at baseline (Table 1) and on POD1 and POD2 (Table 2, which also gives risk differences 5.0% (-4.5% to 14.5%) and 12.5% (0.4% to 24.6%)). Form of VAS taken as mean_sd from the Statistical analysis (means +/- SD). VAS was measured twice on each postoperative day (T2/T3 on day 1, T4/T5 on day 2) and the hours after surgery are not given, so both readings are entered under each day, told apart by location; VAS at T1 (5 min after extubation) left out. Not entered: 'VAS >3 within 48 h' 11 (27.5%) vs 17 (42.5%), and flurbiprofen and paracetamol rescue use and consumption (non-opioid). Adverse events reported are PONV only (10 vs 10); no psychotomimetic events. Enrollment dates are from Methods ('from July 7, 2022 to Feb 20, 2023'). Registration on ClinicalTrials.gov is stated without a number.", "decided_by": "both coders" }, { "trial": "T071", "source": "fulltext", "arms": { "Ketamine": { "randomized": "16", "analysed": null }, "Normal saline placebo": { "randomized": "16", "analysed": null } }, "depression": [ { "measure": "MADRS", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative MADRS); same in Results text", "values": { "Ketamine": { "median": "14.5", "q1": "9", "q3": "21", "n": "16" }, "Normal saline placebo": { "median": "12.5", "q1": "6", "q3": "23.5", "n": "16" } } }, { "measure": "MADRS", "day": 4, "form": "median_iqr", "location": "Results, Collection of clinical outcomes, text (post-infusion day 4)", "values": { "Ketamine": { "median": "4", "q1": "2", "q3": "16" }, "Normal saline placebo": { "median": "6", "q1": "3.5", "q3": "12" } } } ], "pain": [ { "measure": "total opioid dose (oral morphine equivalents) to 07:00 post-infusion day 2", "day": 2, "form": "median_iqr", "location": "Results, Collection of clinical outcomes, text", "values": { "Ketamine": { "median": "78.2", "q1": "52.5", "q3": "219" }, "Normal saline placebo": { "median": "118", "q1": "32.2", "q3": "179.5" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 2 (during the study infusion)", "values": { "Ketamine": { "dizziness": "5", "visual": "2", "agitation": "0" }, "Normal saline placebo": { "dizziness": "2", "visual": "1", "agitation": "1" } } } ], "blinding_check": { "who": "participants", "when": "1 day after the infusion", "location": "Results, Study medication administration", "values": { "Ketamine": { "correct": "7", "n": "16" }, "Normal saline placebo": { "correct": "7", "n": "16" } } }, "enrollment": { "start": "2022-05-05", "end": "2023-02-21" }, "registration": { "number": "NCT05233566", "date": "2022-02-10" }, "note": "Feasibility trial; the study drug started after extubation, so days are the source's post-infusion days (infusion delayed to POD 1 for three control participants and to POD 2 for one ketamine participant). 16 per arm randomized (Table 1 N); no per-arm analysed n (MADRS completed at 170 of 192 planned assessments). MADRS on days 1, 2, 7 and 14 appears only in Figure 4 (box plots); the day-4 medians (IQR) come from the Results text, with no n. Median regression difference in change from baseline to day 4, adjusted for baseline: −1.00 (95% CI −3.23 to 1.73); post hoc subgroup with baseline MADRS >6: −1.76 (−3.63 to 2.77). Pain scores appear only in supplementary figures. Opioid: 'cumulative postoperative opioid exposure between the start of the study medication infusion and 07:00 am on post-infusion day 2', printed as 78.2 (IQR 52.5–219) vs 118 (IQR 32.2–179.5) oral morphine milligram equivalents; the central value is read as a median because an IQR is given; entered as day 2 per the design. Adverse events from Table 2, during the infusion (3 control participants refused or could not be interviewed, so control rows total 13): Dizziness 5 (31) vs 2 (15); Seeing double 2 (12) vs 1 (8) as visual; RASS '1 (Restless)' 0 (0) vs 1 (8) as agitation. Not coded because a count would need summing across scale levels: BPRS hallucinatory behaviour, ketamine 16 (100) no symptoms with 0 (0) at scores 2 and 3, control 11 (85) no symptoms, 1 (8) at score 2 and 1 (8) at score 3; CADSS-6, ketamine 0: 9 (56), 1: 3 (19), 2: 1 (6), 3: 1 (6), 4: 2 (12), 6: 0 (0), control 0: 11 (85), 4: 1 (8), 6: 1 (8); BPRS conceptual disorganisation, ketamine 1 (6) at score 3, control 2 (15) at score 2. Blinding: 'seven out of 16 participants in the ketamine group and seven out of 16 participants in the control group correctly guessed which treatment they received'. One control participant died on postoperative day 13. Enrollment: participants included between 5 May 2022 and 21 February 2023 (recruitment 11 April 2022 to 17 February 2023). Registration date is the 'first posted' date.", "decided_by": "third reader" }, { "trial": "T073", "source": "registry", "arms": { "Epidural morphine 3 mg + IV saline": { "randomized": "26", "analysed": null }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "randomized": "26", "analysed": null } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (presence of postpartum depression)", "day": 7, "form": "mean_range", "location": "Posted results, secondary outcome 'Presence of Postpartum Depression', time frame 1 week after delivery ('MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "7.0", "min": "4.7", "max": "9.4", "n": "19" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "6.7", "min": "4.9", "max": "9.4", "n": "24" } } }, { "measure": "Edinburgh Postnatal Depression Scale (presence of postpartum depression)", "day": 42, "form": "mean_range", "location": "Posted results, secondary outcome 'Presence of Postpartum Depression', time frame 6 weeks after delivery ('MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "4.7", "min": "2.8", "max": "6.6", "n": "19" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "4.8", "min": "3.3", "max": "6.3", "n": "22" } } }, { "measure": "PROMIS-29 depressive symptoms", "day": 90, "form": "mean_range", "location": "Posted results, secondary outcome 'Promis 29 Profile (Depressive Symptoms Question Only)', time frame 3 month, T score ('MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "43", "min": "40.9", "max": "45.2", "n": "20" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "43.6", "min": "41.2", "max": "45.9", "n": "21" } } } ], "pain": [ { "measure": "McGill Pain Questionnaire (perineal pain)", "day": 1, "form": "mean_range", "location": "Posted results, secondary outcome 'Perineal Pain', time frame Day 1 after delivery (MPQ, 'MEAN Full Range')", "values": { "Epidural morphine 3 mg + IV saline": { "mean": "10.4", "min": "7.9", "max": "12.9", "n": "23" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "mean": "12.9", "min": "10.0", "max": "15.8", "n": "24" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Epidural morphine 3 mg + IV saline": { "any_ae": "14" }, "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg": { "any_ae": "13" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT03470675", "date": null }, "note": "Registry posted results. The 'Epidural saline + IV saline' arm (role other) is left out. Randomized is the participant flow 'STARTED' count (26/26); 'COMPLETED' is 17 control / 21 ketamine; analysed n differs by outcome and time, so given per entry and no arm-wide analysed number. The registry labels every secondary result 'MEAN Full Range' (the primary VRS result 'MEAN Inter-Quartile Range'); recorded as form 'mean_range' with lowerLimit/upperLimit as min/max as labelled, but they are probably 95% CIs: they sit near-symmetrically around the means and are non-integers although EPDS totals are integers, so they cannot be minima and maxima. The EPDS outcome is titled 'Presence of Postpartum Depression' but reports mean scores (0-30). Three months coded as day 90. Pain: only the MPQ at day 1 falls in the day 1/2 window; VRS (1 week, 1 year), MPQ (1 week, 6 weeks, 3 months), BPI current pain and PROMIS-29 pain interference (1 week to 3 months) are left out. Adverse events were collected over 48 hours after delivery: serious 0/26 vs 0/25, other 14/26 vs 13/25 (recorded as any_ae); none is psychotomimetic (hypotension, pruritus, fever, back ache, nausea, vomiting, hives, wound problems). No enrollment dates or registration date in the posted results.", "decided_by": "both coders" }, { "trial": "T074", "source": "fulltext", "arms": { "Esketamine group (group E)": { "randomized": "50", "analysed": "50" }, "Control group (group C)": { "randomized": "50", "analysed": "48" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": -1, "form": "count", "definition": "EPDS category 'Depression' (Table 4; cut-offs not stated; the separate 'Mild' category not included)", "location": "Table 4, Preoperative depression", "values": { "Esketamine group (group E)": { "events": "0", "n": "50" }, "Control group (group C)": { "events": "3", "n": "48" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 2, "form": "count", "definition": "EPDS category 'Depression' (Table 4; cut-offs not stated; the separate 'Mild' category not included)", "location": "Table 4, Postoperative depression (postoperative day 2)", "values": { "Esketamine group (group E)": { "events": "0", "n": "50" }, "Control group (group C)": { "events": "1", "n": "48" } } } ], "pain": [ { "measure": "maximum NRS pain within 24 h", "day": 1, "form": "median_iqr", "location": "Results text, paragraph after Table 1", "values": { "Esketamine group (group E)": { "median": "5", "q1": "4", "q3": "5", "n": null }, "Control group (group C)": { "median": "6", "q1": "5", "q3": "6", "n": null } } }, { "measure": "NRS moving incision pain (0-6, 6-12, 12-24 h)", "day": 1, "form": "median_iqr", "location": "Results text after Fig 3, Moving incision pain 12–24 h", "values": { "Esketamine group (group E)": { "median": "4", "q1": "4", "q3": "5", "n": null }, "Control group (group C)": { "median": "5", "q1": "4", "q3": "5", "n": null } } }, { "measure": "NRS rest incision pain (0-6, 6-12, 12-24 h)", "day": 1, "form": "median_iqr", "location": "Results text after Fig 3, Rest incision pain 12–24 h", "values": { "Esketamine group (group E)": { "median": "2", "q1": "1", "q3": "2", "n": null }, "Control group (group C)": { "median": "2", "q1": "1", "q3": "3", "n": null } } }, { "measure": "NRS visceral pain (0-6, 6-12, 12-24 h)", "day": 1, "form": "median_iqr", "location": "Results text after Fig 3, Visceral pain 12–24 h", "values": { "Esketamine group (group E)": { "median": "4", "q1": "2.75", "q3": "4.25", "n": null }, "Control group (group C)": { "median": "5", "q1": "4", "q3": "5.75", "n": null } } }, { "measure": "PCIA presses, rescue analgesic dose, total PCIA consumption", "day": 1, "form": "median_iqr", "location": "Table 3, '12–24 h postoperatively PCIA consumption (mL)'", "values": { "Esketamine group (group E)": { "median": "34.00", "q1": "30.00", "q3": "43.50", "n": "50" }, "Control group (group C)": { "median": "33.00", "q1": "27.00", "q3": "44.25", "n": "48" } } }, { "measure": "PCIA presses, rescue analgesic dose, total PCIA consumption", "day": 1, "form": "median_iqr", "location": "Table 3, '12–24 h postoperatively NOC of PCIA (times)'", "values": { "Esketamine group (group E)": { "median": "4.00", "q1": "2.00", "q3": "7.25", "n": "50" }, "Control group (group C)": { "median": "3.00", "q1": "2.00", "q3": "6.75", "n": "48" } } }, { "measure": "pressure pain threshold and tolerance (30 min, 24 h)", "day": 1, "form": "median_iqr", "location": "Results text, PPT (kgf) T2", "values": { "Esketamine group (group E)": { "median": "2.03", "q1": "1.6", "q3": "2.83", "n": null }, "Control group (group C)": { "median": "2.15", "q1": "1.8", "q3": "2.8", "n": null } } }, { "measure": "pressure pain threshold and tolerance (30 min, 24 h)", "day": 1, "form": "median_iqr", "location": "Results text, PTO (kgf) T2", "values": { "Esketamine group (group E)": { "median": "3.88", "q1": "2.62", "q3": "4.83", "n": null }, "Control group (group C)": { "median": "3.85", "q1": "3.33", "q3": "4.92", "n": null } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 5 (side effects at 24 h postoperatively)", "values": { "Esketamine group (group E)": { "dizziness": "4", "nightmare": "5", "visual": "1" }, "Control group (group C)": { "dizziness": "3", "nightmare": "2", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-12-12", "end": "2025-04-18" }, "registration": { "number": "ChiCTR2300078310", "date": null }, "note": "Two group C dropouts (PCIA failure 3 h and voluntary withdrawal 8 h after surgery); 98 analysed (50/48). Depression: Table 4 gives EPDS categories No / Mild / Depression without cut-offs; events = the 'Depression' row. Mild: preoperative E 13 (26%), C 8 (16.7%); postoperative day 2 E 2 (4%), C 7 (14.6%). No: preoperative E 37, C 37; postoperative E 48, C 40. The text's lower postpartum depression in group E (P = 0.038) tests the whole distribution. Pain was measured only to 24 h. The NRS interval entries are the maximum in the 12–24 h interval, entered as day 1 (0–6 and 6–12 h left out); they, the maximum NRS within 24 h, and PPT and PTO are printed in the Results text with no n. Group C's visceral 12–24 h upper quartile is printed '5. 75' (recorded 5.75), and its rest 12–24 h IQR '[1, 3]'. The design's PCIA measure has two Table 3 rows at 12–24 h, PCIA consumption (mL) and number of compressions (times), both under the design's name and told apart by location; both are values for the 12–24 h interval, not cumulative to 24 h. Rescue analgesia: one group C patient received 150 mg tramadol. PPT and PTO: T0/T1/T2 are not defined in the text; Methods measure them preoperatively and at 30 min and 24 h postoperatively, so T2 is taken as 24 h (day 1); both are under the design's name, told apart by location. Left out as cumulative over 0–24 h rather than at 24 h, and not a design measure (Table 2, E vs C): cumulative resting pain score 4 (3–5) vs 5(4–6); cumulative moving pain score 11 (10–12) vs 13 (12–14.75); cumulative visceral pain score 9.14 ± 3.02 vs 11.79 ± 2.47. Side effects (Table 5) were assessed at 24 h postoperatively; diplopia coded as visual; not coded: drowsiness 5 vs 2, nausea and vomiting 8 vs 2. Results say there was no unblinding (no guess data).", "decided_by": "third reader" }, { "trial": "T075", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "68", "analysed": "68" }, "Normal saline control group": { "randomized": "68", "analysed": "68" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "median_iqr", "location": "Table 1 (HADS-D score, median (IQR), preoperative)", "values": { "Esketamine group": { "median": "6", "q1": "5", "q3": "7", "n": "68" }, "Normal saline control group": { "median": "6", "q1": "5", "q3": "7", "n": "68" } } }, { "measure": "HADS-D", "day": 1, "form": "median_iqr", "location": "Table 3 (HADS-D score, median (IQR), POD1)", "values": { "Esketamine group": { "median": "4", "q1": "3", "q3": "5", "n": "68" }, "Normal saline control group": { "median": "5", "q1": "4", "q3": "6", "n": "68" } } }, { "measure": "HADS-D", "day": 3, "form": "median_iqr", "location": "Table 3 (HADS-D score, median (IQR), POD3)", "values": { "Esketamine group": { "median": "2", "q1": "1", "q3": "3", "n": "68" }, "Normal saline control group": { "median": "3", "q1": "2", "q3": "4", "n": "68" } } } ], "pain": [ { "measure": "moderate-to-severe pain (NRS >= 4 on coughing) on POD1", "day": 1, "form": "count", "definition": "NRS ≥ 4 during coughing", "location": "Table 3 (Primary outcome); also Results text", "values": { "Esketamine group": { "events": "35", "n": "68" }, "Normal saline control group": { "events": "47", "n": "68" } } }, { "measure": "NRS at rest (4 h, 8 h, POD1, POD3)", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS pain score at rest, POD1)", "values": { "Esketamine group": { "median": "2", "q1": "2", "q3": "4", "n": "68" }, "Normal saline control group": { "median": "3", "q1": "2", "q3": "4", "n": "68" } } }, { "measure": "NRS at rest (4 h, 8 h, POD1, POD3)", "day": 1, "form": "mean_se", "location": "Table 5 (GEE estimated marginal means, at rest, Postop 1 d)", "values": { "Esketamine group": { "mean": "2.35", "se": "0.181", "lower": "2.00", "upper": "2.71", "level": "0.95", "n": "68" }, "Normal saline control group": { "mean": "3.54", "se": "0.221", "lower": "3.11", "upper": "3.98", "level": "0.95", "n": "68" } } }, { "measure": "NRS during coughing (4 h, 8 h, POD1, POD3)", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS pain score during coughing, POD1)", "values": { "Esketamine group": { "median": "3", "q1": "3", "q3": "5", "n": "68" }, "Normal saline control group": { "median": "4", "q1": "3", "q3": "6", "n": "68" } } }, { "measure": "NRS during coughing (4 h, 8 h, POD1, POD3)", "day": 1, "form": "mean_se", "location": "Table 5 (GEE estimated marginal means, during coughing, Postop 1 d)", "values": { "Esketamine group": { "mean": "3.41", "se": "0.172", "lower": "3.08", "upper": "3.75", "level": "0.95", "n": "68" }, "Normal saline control group": { "mean": "4.79", "se": "0.234", "lower": "4.34", "upper": "5.25", "level": "0.95", "n": "68" } } }, { "measure": "PCIA volume and hydromorphone consumed", "day": 2, "form": "median_iqr", "unit": "mg hydromorphone", "location": "Table 3 (PCIA utilization, Hydromorphone, mg)", "values": { "Esketamine group": { "median": "6.96", "q1": "6.24", "q3": "7.36", "n": "68" }, "Normal saline control group": { "median": "7.44", "q1": "6.74", "q3": "7.82", "n": "68" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 9", "values": { "Esketamine group": { "hallucination": "2", "nightmare": "6" }, "Normal saline control group": { "hallucination": "1", "nightmare": "4" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR2500098525", "date": "2025-03-10" }, "note": "136 were randomized 1:1 with no withdrawals or protocol deviations; the intention-to-treat analysis includes all 136, and every table header prints n = 68 per arm, so randomized and analysed are both 68. Tables list Control first, Esketamine second. HADS-D is median (IQR); the baseline is Table 1's preoperative value (patients were screened the day before surgery), entered as day -1. Table 3's median differences are printed positive (control minus esketamine) while the text gives them negative; per-arm medians are entered, so there are no difference entries. Pain: POD1 is day 1; the 4 h, 8 h and POD3 values fall outside the day 1 and day 2 windows and are left out. The primary outcome is defined in the Methods as NRS ≥ 4 during coughing on POD1; the Results text says 'within 24 hours' (35/68 vs 47/68, RR 0.75, 95% CI 0.56-0.99). POD1 pain is printed in two forms, medians (IQR) in Table 3 and GEE estimated marginal means with SE and 95% CI in Table 5 (model-based, 'Postop 1 d'); both are entered, the mean_se entries carrying the printed CI bounds as extra fields. Table 5 prints no n; the GEE model used the same POD1 assessments of all 68 per arm that Table 3 reports, so n is 68. Opioid: Table 3 gives total PCIA use with no time stated; the pump ran a background infusion for 48 hours, so it is entered at day 2 as an inference. Hydromorphone (mg) is entered; the PCIA volume (mL) is the same consumption in volume, 87 (78-92) esketamine vs 93 (84.25-97.75) control (8 mg hydromorphone per 100 mL). Intraoperative remifentanil (1.2 [0.9-1.7] vs 1.45 [1.1-1.9] mg) and sufentanil (40 [40-50] vs 45 [40-50] µg) are day 0 and left out. Adverse events (Table 9, postoperative): also 'Confusion and disorientation', 2 esketamine vs 3 control (not dissociation as the codebook defines it), delirium by 3D-CAM on POD1-3, 6 vs 7 (not the emergence excitement the codebook counts as agitation), and nausea and vomiting, 11 vs 21; none is entered. No enrollment period is stated; the registration date is from the Methods. Esketamine 0.25 mg/kg bolus after induction, then 0.25 mg/kg/h, stopped 15 min before the end of surgery; general anaesthesia (propofol, remifentanil).", "decided_by": "third reader" }, { "trial": "T076", "source": "fulltext", "arms": { "Sufentanil group (S1)": { "randomized": "45", "analysed": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "randomized": "45", "analysed": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "randomized": "45", "analysed": "41" } }, "depression": [ { "measure": "HAM-D", "day": -1, "form": "mean_sd", "location": "Table 2", "values": { "Sufentanil group (S1)": { "mean": "14.02", "sd": "1.95", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "14.31", "sd": "2.29", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "14.51", "sd": "2.23", "n": "41" } } }, { "measure": "HAM-D", "day": 1, "form": "mean_sd", "location": "Table 2", "values": { "Sufentanil group (S1)": { "mean": "14.18", "sd": "1.97", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "13.38", "sd": "1.67", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "12.41", "sd": "1.73", "n": "41" } } }, { "measure": "HAM-D", "day": 2, "form": "mean_sd", "location": "Table 2", "values": { "Sufentanil group (S1)": { "mean": "12.30", "sd": "1.75", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "11.55", "sd": "1.73", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "10.73", "sd": "1.41", "n": "41" } } }, { "measure": "HAM-D", "day": 5, "form": "mean_sd", "location": "Table 2", "values": { "Sufentanil group (S1)": { "mean": "10.57", "sd": "1.66", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "9.64", "sd": "1.50", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "9.49", "sd": "1.27", "n": "41" } } }, { "measure": "HAM-D", "day": 7, "form": "mean_sd", "location": "Table 2", "values": { "Sufentanil group (S1)": { "mean": "8.68", "sd": "1.14", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "8.52", "sd": "1.29", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "8.49", "sd": "0.95", "n": "41" } } } ], "pain": [ { "measure": "VAS (1, 6, 12, 24, 48 h)", "day": 1, "form": "mean_sd", "location": "Table 2", "values": { "Sufentanil group (S1)": { "mean": "2.43", "sd": "0.50", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "2.14", "sd": "0.52", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "2.02", "sd": "0.42", "n": "41" } } }, { "measure": "VAS (1, 6, 12, 24, 48 h)", "day": 2, "form": "mean_sd", "location": "Table 2", "values": { "Sufentanil group (S1)": { "mean": "1.93", "sd": "0.50", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "1.64", "sd": "0.48", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "1.54", "sd": "0.50", "n": "41" } } }, { "measure": "PCIA button presses over 48 h", "day": 2, "form": "mean_sd", "location": "Table 4", "values": { "Sufentanil group (S1)": { "mean": "6.98", "sd": "0.63", "n": "44" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "mean": "6.67", "sd": "0.65", "n": "42" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "mean": "6.46", "sd": "0.55", "n": "41" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 4 (postoperative 48 h)", "values": { "Sufentanil group (S1)": { "dizziness": "5", "hallucination": "3" }, "Sufentanil + 0.25 mg/kg esketamine group (SK1)": { "dizziness": "4", "hallucination": "5" }, "Sufentanil + 0.5 mg/kg esketamine group (SK2)": { "dizziness": "5", "hallucination": "5" } } } ], "blinding_check": null, "enrollment": { "start": "2022-11", "end": "2023-12" }, "registration": { "number": "ChiCTR2200065198", "date": "2022-10-31" }, "note": "Randomized per arm from the sample size paragraph ('we recruited 45 patients per group (total N = 135)'). The Methods also give S1 n = 44, SK1 n = 42, SK2 n = 41 as the allocated groups, but the Results give these as the final analysed groups after losses (S1 1; SK1 3; SK2 4). HAM-D and VAS from Table 2, significance letters dropped; VAS 24 h is day 1 and 48 h day 2. PCIA presses over 48 h from Table 4. Intraoperative remifentanil (day 0) not recorded. Adverse events were collected over the postoperative 48 h. Enrollment dates from Methods.", "decided_by": "both coders" }, { "trial": "T077", "source": "fulltext", "arms": { "Esketamine (ESK) group": { "randomized": null, "analysed": "58" }, "Control (CON) group": { "randomized": null, "analysed": "58" } }, "depression": [ { "measure": "Self-Rating Depression Scale (SDS)", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative SDS score)", "values": { "Esketamine (ESK) group": { "median": "21", "q1": "21", "q3": "25", "n": "58" }, "Control (CON) group": { "median": "22", "q1": "21", "q3": "25", "n": "58" } } }, { "measure": "Self-Rating Depression Scale (SDS)", "day": 1, "form": "median_iqr", "location": "Table 2 (SDS 24 hours)", "values": { "Esketamine (ESK) group": { "median": "21", "q1": "20", "q3": "23", "n": "58" }, "Control (CON) group": { "median": "22", "q1": "21", "q3": "24", "n": "58" } } }, { "measure": "Self-Rating Depression Scale (SDS)", "day": 3, "form": "median_iqr", "location": "Table 2 (SDS 72 hours)", "values": { "Esketamine (ESK) group": { "median": "20", "q1": "20", "q3": "21", "n": "58" }, "Control (CON) group": { "median": "20", "q1": "20", "q3": "21", "n": "58" } } } ], "pain": [ { "measure": "VAS pain score (24, 72 h)", "day": 1, "form": "median_iqr", "location": "Table 2 (VAS 24 hours)", "values": { "Esketamine (ESK) group": { "median": "1", "q1": "1", "q3": "3", "n": "58" }, "Control (CON) group": { "median": "2", "q1": "1", "q3": "4", "n": "58" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2024-11", "end": "2025-04" }, "registration": { "number": "ChiCTR2400092257", "date": null }, "note": "Randomized per arm is not printed: the Results say 145 were randomized and 29 excluded from the per-protocol analysis (ESK: 6 electrode detachments, 4 lost to follow-up, 4 benign histology; CON: 9, 3, and 3), leaving 58 per group, and all 145 were in the safety analysis; Figure 1's numbers are not in the text. The sample-size paragraph instead says 116 were enrolled with 58 randomly allocated to each group, which conflicts with the Results. Table 1 and Table 2 present SDS as median (IQR) (Table 2 note; Table 1's two-number format is its median (IQR) form). VAS at 72 hours (Table 2: ESK 1 (1, 1), CON 1 (1, 2.5)) is outside the day 1 and 2 windows and left out. Adverse events (vomiting, agitation, and others) are reported only as not differing, with counts in Supplementary Table 1, which is not in the source text. The registration is described as prospective but no date is given.", "decided_by": "both coders" }, { "trial": "T080", "source": "fulltext", "arms": { "Low-dose group (L)": { "randomized": "75", "analysed": "75" }, "High-dose group (H)": { "randomized": "75", "analysed": "75" }, "Control group (C)": { "randomized": "75", "analysed": "75" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "mean_sd", "location": "Table 3, Before surgery", "values": { "Low-dose group (L)": { "mean": "12.3", "sd": "6.0", "n": "75" }, "High-dose group (H)": { "mean": "12.6", "sd": "5.8", "n": "75" }, "Control group (C)": { "mean": "12.7", "sd": "5.4", "n": "75" } } }, { "measure": "HAMD-17", "day": 1, "form": "mean_sd", "location": "Table 3, Day 1", "values": { "Low-dose group (L)": { "mean": "10.3", "sd": "4.2", "n": "75" }, "High-dose group (H)": { "mean": "10.1", "sd": "4.1", "n": "75" }, "Control group (C)": { "mean": "14.4", "sd": "3.8", "n": "75" } } }, { "measure": "HAMD-17", "day": 3, "form": "mean_sd", "location": "Table 3, Day 3", "values": { "Low-dose group (L)": { "mean": "10.5", "sd": "5.8", "n": "75" }, "High-dose group (H)": { "mean": "9.2", "sd": "3.6", "n": "75" }, "Control group (C)": { "mean": "13.5", "sd": "4.2", "n": "75" } } }, { "measure": "HAMD-17", "day": 7, "form": "mean_sd", "location": "Table 3, Day 7", "values": { "Low-dose group (L)": { "mean": "11.9", "sd": "5.6", "n": "75" }, "High-dose group (H)": { "mean": "11.6", "sd": "3.9", "n": "75" }, "Control group (C)": { "mean": "12.1", "sd": "4.7", "n": "75" } } } ], "pain": [ { "measure": "VAS (4, 8, 12, 24, 48 h)", "day": 1, "form": "mean_sd", "location": "Table 5, VAS T4 (24 h)", "values": { "Low-dose group (L)": { "mean": "2.1", "sd": "0.9", "n": "75" }, "High-dose group (H)": { "mean": "1.8", "sd": "1.0", "n": "75" }, "Control group (C)": { "mean": "1.7", "sd": "1.0", "n": "75" } } }, { "measure": "VAS (4, 8, 12, 24, 48 h)", "day": 2, "form": "mean_sd", "location": "Table 5, VAS T5 (48 h)", "values": { "Low-dose group (L)": { "mean": "1.2", "sd": "0.8", "n": "75" }, "High-dose group (H)": { "mean": "1.1", "sd": "0.9", "n": "75" }, "Control group (C)": { "mean": "0.9", "sd": "0.3", "n": "75" } } }, { "measure": "total postoperative sufentanil consumption over 48 h", "day": 2, "form": "mean_sd", "location": "Table 7, Sufentanil dosage (μg)", "values": { "Low-dose group (L)": { "mean": "69.2", "sd": "4.8", "n": "75" }, "High-dose group (H)": { "mean": "66.7", "sd": "5.1", "n": "75" }, "Control group (C)": { "mean": "83.0", "sd": "5.6", "n": "75" } } }, { "measure": "PCA compressions", "day": 2, "form": "mean_sd", "location": "Table 7, PCA compressions", "values": { "Low-dose group (L)": { "mean": "5.3", "sd": "2.8", "n": "75" }, "High-dose group (H)": { "mean": "2.1", "sd": "1.2", "n": "75" }, "Control group (C)": { "mean": "11.5", "sd": "3.5", "n": "75" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 9 (adverse reactions after surgery)", "values": { "Low-dose group (L)": { "dizziness": "10", "nightmare": "2", "agitation": "0" }, "High-dose group (H)": { "dizziness": "10", "nightmare": "2", "agitation": "0" }, "Control group (C)": { "dizziness": "7", "nightmare": "0", "agitation": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-09", "end": "2024-06" }, "registration": null, "note": "ITT with last observation carried forward for HAMD; the number of dropouts is not given and every table gives N = 75 per group. Sufentanil consumption and PCA compressions (Table 7) cover the 48-h pump period (day 2); intraoperative sufentanil (design day 0) not extracted. Table 9 'Delirium' (0 in every group) coded agitation. Enrollment period from Methods; no registration number in the text. Check: the pilot values in the sample-size paragraph (day 3 control 13.5 ± 4.2, esketamine 10.5 ± 5.8) equal Table 3's day 3 values for C and L, and Table 3's baseline C 12.7 ± 5.4 and L 12.3 ± 6.0 and day 1 C 14.4 ± 3.8 equal the HDR values in this batch's T005 abstract (pmid:12088953). Table 2's header names 'L Group' twice; Table 4 prints the day 3 H vs L CI as [−2.8, 0.2] where the text has [−2.8, −0.2].", "decided_by": "both coders" }, { "trial": "T081", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "71", "analysed": "71" }, "Saline control group": { "randomized": "71", "analysed": "71" } }, "depression": [ { "measure": "HADS depression subscale (HADS-D, Chinese HADS)", "day": -1, "form": "count", "definition": "HADS-D ≥ 8 (0–7 normal)", "location": "Table 2", "values": { "Esketamine group": { "events": "26", "n": "71" }, "Saline control group": { "events": "25", "n": "71" } } }, { "measure": "HADS depression subscale (HADS-D, Chinese HADS)", "day": 7, "form": "count", "definition": "HADS-D ≥ 8 (0–7 normal)", "location": "Table 3", "values": { "Esketamine group": { "events": "5", "n": "71" }, "Saline control group": { "events": "22", "n": "71" } } }, { "measure": "HADS depression subscale (HADS-D, Chinese HADS)", "day": 7, "form": "difference", "location": "Results 3.2, text", "estimate": "1.61", "lower": "0.40", "upper": "2.82", "level": "0.95", "scale": "mean_difference", "comparison": "Saline control group minus Esketamine group", "values": { "Esketamine group": { "n": null }, "Saline control group": { "n": null } }, "contrast_sign": "control_minus_ketamine" }, { "measure": "HADS depression subscale (HADS-D, Chinese HADS)", "day": 30, "form": "count", "definition": "HADS-D ≥ 8 (0–7 normal)", "location": "Table 3", "values": { "Esketamine group": { "events": "0", "n": "71" }, "Saline control group": { "events": "3", "n": "71" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "psychiatric_any": "13", "visual": "1" }, "Saline control group": { "psychiatric_any": "6", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2024-09", "end": "2025-03" }, "registration": { "registry": "ClinicalTrials.gov", "number": "NCT06608030", "date": null }, "note": "Baseline depression: Table 2 gives control 25 (35.2) and esketamine 26 (36.6), but the Results text gives 25/71 for esketamine and 26/71 for controls; took the table's. Depression = HADS-D of 8 or more (0–7 normal, per Methods). n = 71 per group is the ITT population (4 per group lost the primary endpoint; per-protocol results are in Table S3). HADS-D scores appear only as a post hoc mixed-model difference at POD 7: MD 1.61 (SEM 0.61), 95% CI 0.40 to 2.82, Sidak-adjusted, the esketamine group lower (control minus esketamine); arm ns not given. 'Reduction of HADS score ≥ 2 / ≥ 50% from baseline' (Table 3) is not HADS-D alone and is not coded. Pain: NRS only at POD 7 and POD 30, none at days 1 to 2. Adverse events are drug-related side effects within 3 days (Table 4): 'Hallucination or nightmares' is one combined count, coded psychiatric_any; 'Nystagmus, blurred vision' coded visual. Delirium within 7 days (control 16, esketamine 7; hyperactive 4 vs 2) is an efficacy outcome and is not coded as agitation. Enrollment is from Methods (enrolled September 2024 to March 2025; first patient 23 September 2024). Registered before enrolment; no date given.", "decided_by": "both coders" }, { "trial": "T082", "source": "fulltext", "arms": { "Esketamine (Group E)": { "randomized": "40", "analysed": "35" }, "Control (Group C)": { "randomized": "40", "analysed": "35" } }, "depression": [ { "measure": "HADS (depression)", "day": 2, "form": "median_iqr", "location": "Table 1 (HADS-D score; POD2 per Results text)", "values": { "Esketamine (Group E)": { "median": "2", "q1": "2", "q3": "5", "n": "35" }, "Control (Group C)": { "median": "4", "q1": "1", "q3": "6", "n": "35" } } } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2025-02", "end": "2025-04" }, "registration": { "number": "ChiCTR2500096770", "date": "2025-02-06" }, "note": "Three-arm trial; Group ED (esketamine-dexmedetomidine, role 'other') is not extracted (randomized 40, analysed 35). Randomized: 120 allocated equally, n = 40 per group; excluded after randomization: C 2 inadequate intraoperative analgesia + 3 surgical plan changes, E 4 inadequate analgesia + 1 massive bleeding; Table 1 heads each group n = 35. Table 1 doesn't label its format; Methods say non-normal variables are median (IQR), so HADS-D '4(1–6)' and '2(2–5)' are recorded as median_iqr; the Results place the HADS on POD2. Preoperative HADS is only in Supplementary Table S1 (not in the source). NRS pain at rest and on movement is shown only in Figure 3 box plots with no printed values, so no pain entries. PCIA presses in Table 1 have no time stated and are left out of pain: total C 8(6–8), E 7(4–8); effective C 7(5–7), E 6(4–7). Rescue analgesia frequency is not reported in the text. Adverse events (nausea and vomiting, pruritus, dizziness, somnolence, and others) are said not to differ, with counts only in Supplementary Table S3.", "decided_by": "both coders" }, { "trial": "T083", "source": "fulltext", "arms": { "Esketamine group": { "randomized": null, "analysed": "40" }, "Normal saline group": { "randomized": null, "analysed": "40" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "median_iqr", "location": "Table 1 (Hamilton Depression Rating Scale, POD-1 = the day before surgery)", "values": { "Esketamine group": { "median": "5.0", "q1": "4.0", "q3": "7.8", "n": "40" }, "Normal saline group": { "median": "4.5", "q1": "3.0", "q3": "7.0", "n": "40" } } }, { "measure": "Self-Rating Depression Scale (SDS)", "day": -1, "form": "median_iqr", "location": "Table 1 (Self-Rating Depression Scale, POD-1 = the day before surgery)", "values": { "Esketamine group": { "median": "39.5", "q1": "32.9", "q3": "43.1", "n": "40" }, "Normal saline group": { "median": "35.5", "q1": "31.1", "q3": "44.1", "n": "40" } } }, { "measure": "HAMD-17", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "4.0", "q1": "3.0", "q3": "7.0", "n": "40" }, "Normal saline group": { "median": "5.5", "q1": "5.0", "q3": "7.8", "n": "40" } } }, { "measure": "HAMD-17", "day": 3, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "4.0", "q1": "2.3", "q3": "6.0", "n": "40" }, "Normal saline group": { "median": "5.1", "q1": "4.1", "q3": "7.1", "n": "40" } } }, { "measure": "HAMD-17", "day": 30, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "3.00", "q1": "2.1", "q3": "4.1", "n": "40" }, "Normal saline group": { "median": "5.0", "q1": "4.0", "q3": "6.2", "n": "40" } } }, { "measure": "Self-Rating Depression Scale (SDS)", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "36.8", "q1": "34.5", "q3": "39.0", "n": "40" }, "Normal saline group": { "median": "40.9", "q1": "38.1", "q3": "43.7", "n": "40" } } }, { "measure": "Self-Rating Depression Scale (SDS)", "day": 3, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "33.8", "q1": "31.9", "q3": "35.8", "n": "40" }, "Normal saline group": { "median": "40.3", "q1": "37.8", "q3": "42.8", "n": "40" } } }, { "measure": "Self-Rating Depression Scale (SDS)", "day": 30, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "33.0", "q1": "31.0", "q3": "34.9", "n": "40" }, "Normal saline group": { "median": "42.2", "q1": "37.3", "q3": "43.1", "n": "40" } } } ], "pain": [ { "measure": "11-point VAS (30 min after extubation, POD1, POD2)", "day": 1, "form": "median_iqr", "location": "Table 4 (Pain visual analog scale score, T4 = 1 day after surgery)", "values": { "Esketamine group": { "median": "3.00", "q1": "3.00", "q3": "4.00", "n": "40" }, "Normal saline group": { "median": "3.00", "q1": "2.00", "q3": "4.00", "n": "40" } } } ], "adverse_events": [ { "window": "overall", "values": { "Esketamine group": { "psychiatric_any": "4", "dizziness": "4", "visual": "0", "hallucination": "0", "nightmare": "0", "agitation": "0" }, "Normal saline group": { "psychiatric_any": "0", "dizziness": "0", "visual": "0", "hallucination": "0", "nightmare": "0", "agitation": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-10", "end": "2024-04" }, "registration": { "number": "ChiCTR2200061575", "date": "2022-06-29" }, "note": "Tables list Normal Saline before Esketamine. Randomized per arm is not printed: 90 were randomized, then 5 per group were excluded (lost to follow-up or withdrew consent), and 40 per group were analysed. Table 1's rows run together in the source ('IIIHamilton Depression Rating Scale 11 (27.5) 14 (35)' is TNM stage III; the next row, 'POD-1Self-Rating Depression Scale 4.5 (3.0, 7.0) 5.0 (4.0, 7.8)', is HAMD-17 at POD-1; the row after, 'POD-1 35.5 (31.1, 44.1) 39.5 (32.9, 43.1)', is SDS at POD-1); POD-1 is defined as the day before surgery and the format as median (IQR). HAMD-17 on POD 30: the Results text prints ESK 3.00 (2.08–4.10) and saline 5.00 (4.00–6.20), Table 2 3.00 (2.1–4.1) and 5.0 (4.0–6.2); the table's values are used. Table 2 labels all values median (IQR), but several SDS intervals are nearly symmetric about the centre value (e.g. 40.9 (38.1–43.7)), so they may be means with CIs; recorded as labelled. Pain: Methods put the VAS at 30 min after extubation (T3), POD 1 (T4), and POD 2 (T5), but Table 4's note and the Results text define T5 as 3 days after surgery (and Methods schedule follow-up on days 1, 3, and 30), so T5 (both 2.00 (2.00–3.00)) is left out as day 3; T3 is day 0 and left out (the text gives it as 3.75±0.14 vs 4.33±0.15 while Table 4 prints 4.00 (3.00–4.00) vs 4.00 (4.00–5.00)). Adverse events are from Table 5; Methods say esketamine-related events were monitored for 72 h postoperatively, but footnotes tie dizziness (infusion transiently stopped) and agitation (RASS ≥ 2) to the drug infusion and the table includes post-induction hypertension, so the window is 'overall'. 'Neuropsychiatric symptoms' (ESK 4, saline 0) is recorded as psychiatric_any; the specific rows 'Hallucination or daymare' (0, 0; recorded as hallucination and nightmare 0), agitation (0, 0), and diplopia (0, 0, as visual) are printed separately. Not codebook categories: tachycardia 2 vs 0, hypertension 1 vs 0, nausea or vomiting 10 vs 7 (ESK vs saline). Enrollment dates are from Methods; the Results don't restate them.", "decided_by": "both coders" }, { "trial": "T084", "source": "abstract", "arms": { "S-ketamine": { "randomized": null, "analysed": null }, "Normal saline": { "randomized": null, "analysed": null } }, "depression": [ { "measure": "PHQ-9", "day": 1, "form": "difference", "location": "abstract (Results)", "estimate": "-1.0", "lower": "-2.0", "upper": "0", "level": "0.95", "scale": "mean_difference", "values": { "S-ketamine": { "n": null }, "Normal saline": { "n": null } }, "contrast_sign": "ketamine_minus_control" } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR 2200065298", "date": null }, "note": "Abstract only; 230 patients were enrolled and randomized, with no per-arm numbers. PHQ-9 on POD 1: 'a reduction in PHQ-9 scores (MD -1.0 [95% CI, -2.0 to 0]; p = 0.002)'. MD is not defined (mean or median difference; scale coded mean_difference) and the subtraction order is not stated: the QoR-15 'MD -2.2 [95% CI: -4.3 to -0.7]' accompanies 'higher QoR-15 scores' with S-ketamine, so the sign convention is unclear; a CI reaching 0 with p = 0.002 is also inconsistent. Treatment response (≥ 50% decrease in PHQ-9 from baseline) on POD 1: OR 1.4 (0.8 to 2.6), p = 0.017, not coded (a response, not a count of depressed participants). PHQ-9 on POD 3 and 7 reported only as similar. Adverse events reported only as comparable.", "decided_by": "both coders" }, { "trial": "T085", "source": "fulltext", "arms": { "Study group (esketamine)": { "randomized": "70", "analysed": "70" }, "Control group (normal saline)": { "randomized": "70", "analysed": "70" } }, "depression": [ { "measure": "PHQ-9 (>= 10 = depressive symptoms)", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative PHQ-9 score)", "values": { "Study group (esketamine)": { "median": "2", "q1": "1", "q3": "4", "n": "70" }, "Control group (normal saline)": { "median": "3", "q1": "1", "q3": "5", "n": "70" } } }, { "measure": "PHQ-9 (>= 10 = depressive symptoms)", "day": -1, "form": "count", "definition": "preoperative depressive symptom, PHQ-9 ≥ 10", "location": "Table 1 (Preoperative depressive symptom)", "values": { "Study group (esketamine)": { "events": "6", "n": "70" }, "Control group (normal saline)": { "events": "3", "n": "70" } } }, { "measure": "PHQ-9 (>= 10 = depressive symptoms)", "day": 7, "form": "median_iqr", "location": "Table 3 (PHQ-9, on POD 7)", "values": { "Study group (esketamine)": { "median": "2", "q1": "1", "q3": "4", "n": null }, "Control group (normal saline)": { "median": "3", "q1": "1", "q3": "6.5", "n": null } } }, { "measure": "PHQ-9 (>= 10 = depressive symptoms)", "day": 7, "form": "count", "definition": "postoperative depressive symptom, PHQ-9 ≥ 10", "location": "Table 3 (Postoperative depressive symptom, on POD 7)", "values": { "Study group (esketamine)": { "events": "5", "n": null }, "Control group (normal saline)": { "events": "6", "n": null } } } ], "pain": [ { "measure": "NRS pain at designated time points", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS, at 24h)", "values": { "Study group (esketamine)": { "median": "1.3", "q1": "1", "q3": "3", "n": "70" }, "Control group (normal saline)": { "median": "2", "q1": "1", "q3": "3", "n": "70" } } }, { "measure": "NRS pain at designated time points", "day": 2, "form": "median_iqr", "location": "Table 3 (NRS, at 48h)", "values": { "Study group (esketamine)": { "median": "1", "q1": "1", "q3": "2", "n": "70" }, "Control group (normal saline)": { "median": "1", "q1": "1", "q3": "2", "n": "70" } } }, { "measure": "total morphine consumption (PACU rescue + PCA) in the first 24 h", "day": 1, "form": "median_iqr", "location": "Table 3 (Morphine, at 24h (mg))", "values": { "Study group (esketamine)": { "median": "4", "q1": "3", "q3": "8", "n": "70" }, "Control group (normal saline)": { "median": "5.5", "q1": "3", "q3": "8", "n": "70" } } } ], "adverse_events": [ { "window": "emergence", "values": { "Study group (esketamine)": { "hallucination": "2", "agitation": "4", "nightmare": "0", "dissociation": "0", "visual": "0" }, "Control group (normal saline)": { "hallucination": "0", "agitation": "0", "nightmare": "0", "dissociation": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2022-09", "end": "2024-03" }, "registration": { "number": "ChiCTR 2200061021", "date": "2022-06-15" }, "note": "140 randomized, 70 per arm, all in the intention-to-treat analysis. PHQ-9 is reported both as scores (median, IQR) and as counts of PHQ-9 ≥ 10 at baseline and on POD 7; both go under the design's single PHQ-9 measure, so each of those times has two entries, one per form. Table 3's columns say n = 70, but the POD 7 percentages (5, 7.2%; 6, 8.7%) fit 69 assessed per arm, so n is left null for the POD 7 entries; the other Table 3 entries take the column n. Table 3 median differences (study minus control, Hodges-Lehmann): PHQ-9 POD 7 −1 (−2 to 0); NRS 24 h 0 (−1 to 0); NRS 48 h 0 (0 to 0); morphine 24 h −1 (−2 to 0). The control NRS at 24 h is printed '2 (1, 3)'. 'Morphine, at 24h' taken as the Methods' total morphine consumption (PACU rescue plus PCA within the first 24 h). NRS in PACU and at 2 h are outside the pain windows. Adverse events are for the PACU stay (Table 5), coded as window emergence: 'Delirium' 4 vs 0 (four study-group patients were confused and given dexmedetomidine) coded as agitation; the zeros for nightmare, dissociation and diplopia come from the text ('no cases of nightmares, dissociation, diplopia, or hypoxemia were recorded'); dizziness was planned but not reported; over sedation (18 vs 3) is not a listed category. Chronic pain (NRS ≥ 4) at 3 months, 1 (1.4%) vs 0 (Table 4, n = 67 and 69), is outside the coded days. Enrollment dates from Methods ('conducted ... between September 2022 and March 2024'); Results give none.", "decided_by": "third reader" }, { "trial": "T086", "source": "fulltext", "arms": { "Esketamine group": { "randomized": null, "analysed": "140" }, "Control group": { "randomized": null, "analysed": "140" } }, "depression": [ { "measure": "EPDS (postpartum depression incidence, >= 10)", "day": -1, "form": "mean_sd", "location": "Table 1, Pre-operative EPDS score", "values": { "Esketamine group": { "mean": "8.9", "sd": "4.0", "n": "140" }, "Control group": { "mean": "9.3", "sd": "4.0", "n": "140" } } }, { "measure": "EPDS (postpartum depression incidence, >= 10)", "day": -1, "form": "count", "definition": "Prenatal depression (Table 1 label; criterion not stated; EPDS and SDS were both given the day before surgery)", "location": "Table 1, 'Prenatal depression, n (%)'", "values": { "Esketamine group": { "events": "57", "n": "140" }, "Control group": { "events": "64", "n": "140" } } }, { "measure": "EPDS (postpartum depression incidence, >= 10)", "day": null, "form": "count", "definition": "EPDS ≥10", "location": "Table 2, PPD (total)", "values": { "Esketamine group": { "events": "41", "n": "140" }, "Control group": { "events": "50", "n": "140" } } } ], "pain": [], "adverse_events": [ { "window": "intraoperative", "location": "Table 4, Intra-operative", "values": { "Esketamine group": { "dizziness": "4", "hallucination": "2", "nightmare": "5" }, "Control group": { "dizziness": "0", "hallucination": "0", "nightmare": "0" } } }, { "window": "postoperative", "location": "Table 4, Post-operative", "values": { "Esketamine group": { "dizziness": "1" }, "Control group": { "dizziness": "4" } } } ], "blinding_check": null, "enrollment": { "start": "2022-01-15", "end": "2022-07-30" }, "registration": { "number": "ChiCTR2100050976", "date": "09/09/2021" }, "note": "Tables 1, 2 and 4 list the control group first. 290 recruited and randomized 1:1; 10 excluded after randomization (2 converted to general anaesthesia, 1 post-partum haemorrhage, 5 lost to follow-up, 2 EPQ L-scale >60), leaving 140 per group; per-arm randomized numbers are not printed (the Fig. 1 flow chart is not reproduced). Day -1 entries are from the assessment the day before surgery. 'Prenatal depression' (Table 1) has no stated criterion or instrument; it is entered under the design's EPDS measure with that said in its definition. Table 1's pre-operative SDS (45.8 ± 9.0 vs 45.7 ± 10.1, esketamine vs control) is not a design measure and is not entered. The time of the postpartum EPDS is not stated anywhere (the sample size cites a 28% PPD incidence 'on the 3rd day after a caesarean section' from another study; median hospital stay 4 days), so day is null for the PPD (total) count, PPD being EPDS >= 10. Table 2 also gives PPD by personality type (subgroups, not entered). Pain: NRS at rest and on movement (4-48 h) and severe-pain rates are only in Figs 2-3 (no printed values); indomethacin use is not reported. Adverse events from Table 4's intra-operative and post-operative rows; drowsiness, nausea/vomiting and RSS >3 not coded. Enrollment period is from Methods, Participants (the Results do not state it).", "decided_by": "third reader" }, { "trial": "T087", "source": "fulltext", "arms": { "Group K (study group)": { "randomized": "70", "analysed": "70" }, "Group C (control group)": { "randomized": "70", "analysed": "70" } }, "depression": [ { "measure": "POMS depression-dejection subscale (within total mood score)", "day": -1, "form": "median_iqr", "location": "Table 1 (POMS Questionnaire, Depression-dejection, before surgery)", "values": { "Group K (study group)": { "median": "9,5", "q1": "3,0", "q3": "18,5" }, "Group C (control group)": { "median": "9,0", "q1": "3,0", "q3": "16,3" } } }, { "measure": "POMS depression-dejection subscale (within total mood score)", "day": 0, "form": "median_iqr", "location": "Table 2 (depression-dejection, 120 min after surgery)", "values": { "Group K (study group)": { "median": "5,0", "q1": "2,0", "q3": "15,0" }, "Group C (control group)": { "median": "5,0", "q1": "2,0", "q3": "15,5" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "values": { "Group K (study group)": { "visual": "2", "psychiatric_any": "0" }, "Group C (control group)": { "psychiatric_any": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2022-04-01", "end": "2022-09-01" }, "registration": null, "note": "Tables print decimal commas (e.g. '9,5' is 9.5); copied as printed. POMS was taken before surgery (Table 1, day -1) and 120 min after surgery (Table 2's lower-case subscale rows under 'Variables during and after surgery', day 0); the text confirms group C's depression subscale fell after surgery (p = 0,048). n is not printed in Tables 1-2; 70 randomized per group (Results) and 70 analysed per group (Table 3's regression headers, Group-K n = 70, Group-C n = 70). The only pain score is NRS at 120 min (Table 2: K 4.0 (0.8) vs C 4.6 (0.7), mean (SD)), day 0, so no pain entries; need for rescue analgesics (34 (48,6) vs 45 (64,3)) has no time beyond 'during and after surgery'. AEs from the Results text: 'Only two patients in group K (2/70 (3%)) suffered headaches and diplopia, while two patients in group C (2/70 (3%)) experienced a headache. Psychomimetic side effects were not reported by any patients.' Entered visual 2 for K (it is unclear whether both patients had both symptoms); no diplopia count for C (none implied, not stated); psychiatric_any 0 in both arms from 'not reported by any patients'. any_ae is not entered: the sentence counts patients with headache and diplopia (K) or headache (C), not patients with any adverse event, and the trial reports no other events (PONV is not mentioned). Window overall (perioperative and postoperative events). No registration number in the text.", "decided_by": "third reader" }, { "trial": "T088", "source": "fulltext", "arms": { "Group A": { "randomized": "65", "analysed": "62" }, "Group B": { "randomized": "65", "analysed": "62" }, "Group C": { "randomized": "64", "analysed": "62" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": -1, "form": "mean_sd", "location": "Discussion, second paragraph (T1, preoperative day 1)", "values": { "Group A": { "mean": "6.94", "sd": "3.535", "n": "62" }, "Group C": { "mean": "5.94", "sd": "3.038", "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 3, "form": "mean_sd", "location": "Discussion, second paragraph (T2, postoperative day 3)", "values": { "Group B": { "mean": "4.37", "sd": "3.370", "n": "62" }, "Group C": { "mean": "5.58", "sd": "3.028", "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 5, "form": "mean_sd", "location": "Discussion, second paragraph (T3, postoperative day 5) for groups B and C; third paragraph (MCID comparison) for group A's mean", "values": { "Group A": { "mean": "3.37", "n": "62" }, "Group B": { "mean": "3.51", "sd": "2.248", "n": "62" }, "Group C": { "mean": "4.86", "sd": "2.631", "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "mean_sd", "location": "Discussion, second paragraph (T4, postoperative day 7) for group B; third paragraph (MCID comparison) for the means of groups A and C", "values": { "Group A": { "mean": "2.35", "n": "62" }, "Group B": { "mean": "3.00", "sd": "1.311", "n": "62" }, "Group C": { "mean": "4.18", "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "mean_sd", "location": "Discussion, second paragraph (T5, postoperative day 14) for groups A and B; third paragraph (MCID comparison) for group C's mean", "values": { "Group A": { "mean": "1.88", "sd": "1.796", "n": "62" }, "Group B": { "mean": "2.76", "sd": "1.159", "n": "62" }, "Group C": { "mean": "3.17", "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 30, "form": "mean_sd", "location": "Discussion, second paragraph (T6, postoperative day 30)", "values": { "Group A": { "mean": "1.57", "sd": "1.565", "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 42, "form": "mean_sd", "location": "Discussion, second paragraph (T7, postoperative day 42)", "values": { "Group A": { "mean": "1.33", "sd": "1.381", "n": "62" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "form": "percent", "location": "Results, Comparison of adverse events (Table 4 not in the source text); also Discussion", "values": { "Group A": { "any_ae_percent": "69.4" }, "Group B": { "any_ae_percent": "30.6" }, "Group C": { "any_ae_percent": "3.2" } } }, { "window": "overall", "location": "Discussion (side-effects paragraph)", "values": { "Group B": { "psychiatric_any": "1" } } } ], "blinding_check": null, "enrollment": { "start": "2024-02-03", "end": "2024-05-05" }, "registration": { "number": "ChiCTR2400080617", "date": "2024-02-02" }, "note": "Tables 1-4 are not in the source (captions with 'Download CSV / Display Table' only), and Figure 3 (adjusted EPDS means with SE bars) prints no values, so every EPDS value comes from the Discussion. Its second paragraph gives 'mean ± x' for single arm-times (T1 = preoperative day 1, entered as day -1; T2-T7 = postoperative days 3, 5, 7, 14, 30 and 42); the ± is not labelled and is read as SD, since as SEs with n = 62 these values would imply SDs beyond the 0-30 scale. Its third (MCID) paragraph prints means inside subtractions, with no SD: day 5 '4.86–3.37' (C, A), day 7 '4.18–2.35' (C, A) and '4.18–3.00' (C, B), day 14 '3.17–1.88' (C, A) and '2.76–1.88' (B, A); the arms follow from the comparison each names and from the second paragraph's values, and these arm-times carry a mean with no sd. Not printed: group B at baseline, 30 and 42 days; group A at day 3; group C at 30 and 42 days. Whether the means are raw or model-adjusted is not stated. Randomized 65, 65 and 64 with 3, 2 and 3 dropouts, yet the Results say the final analysis included 186 patients, 62 per group (65 - 2 = 63 and 64 - 3 = 61 do not match 62); analysed and each entry's n are recorded as printed, 62, since dropouts were removed for incomplete outcome assessments and no n is printed per time. The Discussion also gives Cohen's d (mean difference / pooled SD) for A vs C at days 5, 7 and 14 (0.58, 0.82, 0.70) and for A vs B at day 14 (0.58); these are not entered, since the arms' means are printed and the codebook's difference form is for sources that give only a mean difference, odds ratio or risk ratio. No counts by EPDS cutoff are printed by arm. Pain: VAS at 4, 12, 24 and 48 h and PCIA bolus times are only in Table 3, which is not available; the text says VAS was higher in group A than C at 4 h (p < 0.01), with no differences at 12, 24 or 48 h, and no rescue analgesia was needed. Adverse events: only the percentage of each group with any adverse event is printed (A 69.4%, B 30.6%, C 3.2%), entered in a 'percent' form with a _percent suffix rather than as counts; Table 4's individual events (blurred vision, dizziness, drowsiness, nausea and vomiting, increased secretions, diplopia, hallucinations, hypertension, facial flushing) are not available. The Discussion says one patient in group B had transient psychiatric symptoms after administration, resolved with propofol 1 mg/kg (psychiatric_any 1 for group B only; the other groups are not stated). All side effects occurred during surgery or in the recovery room. Groups A and B both received esketamine 0.25 mg/kg after cord clamping; group A also had esketamine 1 mg/kg in the 48-h PCIA. Combined spinal-epidural anaesthesia. Enrollment is the Results' screening period; registration is 'Date of first registration: February 2nd, 2024'.", "decided_by": "third reader" }, { "trial": "T089", "source": "fulltext", "arms": { "Esk group": { "randomized": "44", "analysed": "41" }, "NS group": { "randomized": "44", "analysed": "41" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Esk group": { "median": "6", "q1": "5", "q3": "7", "n": "41" }, "NS group": { "median": "6", "q1": "5", "q3": "7", "n": "41" } } }, { "measure": "HAMD-17", "day": 7, "form": "median_iqr", "location": "Table 2", "values": { "Esk group": { "median": "7", "q1": "6", "q3": "8", "n": "41" }, "NS group": { "median": "7", "q1": "6", "q3": "12", "n": "41" } } }, { "measure": "HAMD-17", "day": 30, "form": "median_iqr", "location": "Table 2", "values": { "Esk group": { "median": "6", "q1": "6", "q3": "7", "n": "41" }, "NS group": { "median": "7", "q1": "6", "q3": "9", "n": "41" } } } ], "pain": [ { "measure": "NRS at rest (24, 48 h)", "day": 1, "form": "median_iqr", "location": "Table 4", "values": { "Esk group": { "median": "2", "q1": "0", "q3": "2", "n": "41" }, "NS group": { "median": "2", "q1": "0", "q3": "3", "n": "41" } } }, { "measure": "NRS at rest (24, 48 h)", "day": 2, "form": "median_iqr", "location": "Table 4", "values": { "Esk group": { "median": "0", "q1": "0", "q3": "1", "n": "41" }, "NS group": { "median": "0", "q1": "0", "q3": "1", "n": "41" } } }, { "measure": "NRS on coughing (24, 48 h)", "day": 1, "form": "median_iqr", "location": "Table 4", "values": { "Esk group": { "median": "3", "q1": "1", "q3": "4", "n": "41" }, "NS group": { "median": "3", "q1": "1", "q3": "4", "n": "41" } } }, { "measure": "NRS on coughing (24, 48 h)", "day": 2, "form": "median_iqr", "location": "Table 4", "values": { "Esk group": { "median": "1", "q1": "0", "q3": "2", "n": "41" }, "NS group": { "median": "1", "q1": "0", "q3": "3", "n": "41" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Esk group": { "psychiatric_any": "1", "agitation": "0", "dizziness": "3" }, "NS group": { "psychiatric_any": "1", "agitation": "1", "dizziness": "2" } } } ], "blinding_check": null, "enrollment": { "start": "2023-08", "end": "2024-06" }, "registration": null, "note": "88 randomized, 44 per group (Methods 1.1); 3 per group excluded after randomization, 41 per group analysed. HAMD-17 is median (P25, P75), n = 41 per column; baseline was 1 day before surgery. HAMD-17 ≥ 8 defines depression, but no counts are reported. Pain NRS (Table 4, n = 41 per group) at 24 h and 48 h. Adverse events (Table 4, postoperative): 'Hallucination or nightmare' is one combined count, coded psychiatric_any; 'Headache or dizziness' is one combined count, coded dizziness although it includes headache; agitation as printed. Enrollment is from Methods (patients operated August 2023 to June 2024). No registration number in the text.", "decided_by": "both coders" }, { "trial": "T090", "source": "fulltext", "arms": { "Control group (group C)": { "randomized": "30", "analysed": null }, "Esketamine group S1": { "randomized": "30", "analysed": null }, "Esketamine group S2": { "randomized": "30", "analysed": null }, "Esketamine group S3": { "randomized": "30", "analysed": null } }, "depression": [ { "measure": "HADS depression subscale", "day": -1, "form": "mean_sd", "location": "Table 4, Preoperative", "values": { "Control group (group C)": { "mean": "3.70", "sd": "1.57", "n": null }, "Esketamine group S1": { "mean": "3.23", "sd": "1.45", "n": null }, "Esketamine group S2": { "mean": "3.10", "sd": "1.57", "n": null }, "Esketamine group S3": { "mean": "3.62", "sd": "1.32", "n": null } } }, { "measure": "HADS depression subscale", "day": null, "form": "mean_sd", "location": "Table 4, rows under 'Postoperativ' (time not stated)", "values": { "Control group (group C)": { "mean": "3.42", "sd": "1.30", "n": null }, "Esketamine group S1": { "mean": "2.75", "sd": "1.35", "n": null }, "Esketamine group S2": { "mean": "3.13", "sd": "1.35", "n": null }, "Esketamine group S3": { "mean": "3.33", "sd": "1.33", "n": null } } } ], "pain": [ { "measure": "NRS at rest (3, 6, 12, 24, 48 h)", "day": 1, "form": "median_iqr", "location": "Table 3, 24h (static state)", "values": { "Control group (group C)": { "median": "1", "q1": "1", "q3": "1.25", "n": null }, "Esketamine group S1": { "median": "1", "q1": "1", "q3": "2", "n": null }, "Esketamine group S2": { "median": "0", "q1": "0", "q3": "1", "n": null }, "Esketamine group S3": { "median": "0", "q1": "0", "q3": "1", "n": null } } }, { "measure": "NRS at rest (3, 6, 12, 24, 48 h)", "day": 2, "form": "median_iqr", "location": "Table 3, 48h (static state)", "values": { "Control group (group C)": { "median": "1", "q1": "0", "q3": "1", "n": null }, "Esketamine group S1": { "median": "1", "q1": "1", "q3": "1", "n": null }, "Esketamine group S2": { "median": "0", "q1": "0", "q3": "1", "n": null }, "Esketamine group S3": { "median": "0", "q1": "0", "q3": "1", "n": null } } }, { "measure": "NRS during exercise (3, 6, 12, 24, 48 h)", "day": 1, "form": "median_iqr", "location": "Table 2, 24h (exercise status)", "values": { "Control group (group C)": { "median": "2", "q1": "2", "q3": "2", "n": null }, "Esketamine group S1": { "median": "2", "q1": "1", "q3": "2", "n": null }, "Esketamine group S2": { "median": "1", "q1": "1", "q3": "2", "n": null }, "Esketamine group S3": { "median": "1", "q1": "1", "q3": "1", "n": null } } }, { "measure": "NRS during exercise (3, 6, 12, 24, 48 h)", "day": 2, "form": "median_iqr", "location": "Table 2, 48h (exercise status)", "values": { "Control group (group C)": { "median": "1", "q1": "1", "q3": "2", "n": null }, "Esketamine group S1": { "median": "1", "q1": "1", "q3": "2", "n": null }, "Esketamine group S2": { "median": "0", "q1": "0", "q3": "1", "n": null }, "Esketamine group S3": { "median": "0", "q1": "0", "q3": "1", "n": null } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 9", "values": { "Control group (group C)": { "dizziness": "5", "visual": "0" }, "Esketamine group S1": { "dizziness": "4", "visual": "0" }, "Esketamine group S2": { "dizziness": "2", "visual": "0" }, "Esketamine group S3": { "dizziness": "3", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-03", "end": "2024-03", "location": "Methods (patients included between March 2023 and March 2024); the Results give no dates" }, "registration": { "number": "ChiCTR2400090449", "date": null }, "note": "Esketamine at induction 0.15 (S1), 0.25 (S2), 0.35 (S3) mg/kg, given until 30 min before the end of surgery; group C saline. 120 randomized, 30 per group (Methods). No analysed numbers are stated; the tables' counts sum to 29 for S2 (for example Table 1 male 6 + female 23; Table 9 'Diplopia No 29(100)') and 30 for the others, so analysed is left blank. HADS-D is Table 4's 'HDAS-D' row (mean ± SD); preoperative = day -1; the time of the postoperative assessment is not stated anywhere (the Methods list HADS among 'postoperative assessments'), so its day is null. NRS is printed as median (Q1, Q3) without n; Table 2 'exercise status' = during exercise, Table 3 'static state' = at rest; superscripts a, b dropped; the 3, 6 and 12 h values fall outside the day windows. Not entered: sufentanil consumption (Table 8, 37.30 ± 1.58, 36.90 ± 2.33, 27.48 ± 1.88, 21.73 ± 1.82 µg; given intermittently during maintenance, no postoperative time) and remedial analgesia (Table 9 yes 10 (33.3), 8 (26.7), 6 (20.7), 0 (0); unstated postoperative period). Adverse events, Table 9 (postoperative): 'Dizzy giddy' yes = dizziness; the Diplopia row prints only 'No 30(100) 30(100) 29(100) 30(100)', that is, no one in any group had diplopia, recorded as visual 0 (the text lists diplopia among the adverse reactions compared). The Nightmare row prints 'yes 30(100) 30(100) 29(100) 30(100)', which would mean every patient had nightmares and is presumably a mislabelled 'No' row; not entered. Nausea and vomiting is not a codebook category. Single-blind; no blinding check.", "decided_by": "third reader" }, { "trial": "T092", "source": "fulltext", "arms": { "Esketamine group (group E)": { "randomized": "40", "analysed": "40" }, "Saline group (group C)": { "randomized": "40", "analysed": "39" } }, "depression": [], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 3", "values": { "Esketamine group (group E)": { "agitation": "1", "dizziness": "1" }, "Saline group (group C)": { "agitation": "1", "dizziness": "1" } } } ], "blinding_check": null, "enrollment": { "start": "2023-02", "end": "2023-06" }, "registration": { "number": "ChiCTR2200063302", "date": null }, "note": "SAS and SDS only in Figures 2-3 (mean ± SD, no printed values), so no depression entries; the text says postoperative SDS was lower with esketamine (P < .05). The only pain measure is VAS after recovery (0.98 ± 0.73 vs 0.97 ± 0.87, Table 1), day 0, not recorded. Adverse events (Table 3, postoperative): restlessness coded as agitation, vertigo as dizziness. One control patient withdrew. Enrollment dates from Methods.", "decided_by": "both coders" }, { "trial": "T093", "source": "library", "arms": { "Esketamine": { "randomized": "54", "analysed": "52" }, "Placebo (20 mL normal saline)": { "randomized": "54", "analysed": "52" } }, "depression": [ { "measure": "MADRS (response = 50% reduction on POD 3; remission <=10)", "day": -1, "form": "median_iqr", "location": "Table 1 (MADRS score, median (IQR))", "values": { "Esketamine": { "median": "20.00", "q1": "17.00", "q3": "23.25", "n": "52" }, "Placebo (20 mL normal saline)": { "median": "21.00", "q1": "17.00", "q3": "24.00", "n": "52" } } }, { "measure": "MADRS (response = 50% reduction on POD 3; remission <=10)", "day": 1, "form": "difference", "definition": "odds ratio of MADRS response (≥ 50 % reduction from baseline), esketamine vs placebo; responders, not participants with depression (33 % vs 15 % responders)", "location": "Results 3.1, second paragraph (text, postoperative day 1; Fig. 2A, C)", "estimate": "2.7", "lower": "1.0", "upper": "6.9", "level": "0.95", "scale": "odds_ratio", "values": { "Esketamine": { "n": "52" }, "Placebo (20 mL normal saline)": { "n": "52" } }, "counts": "improvement", "contrast_sign": "ketamine_versus_control" }, { "measure": "MADRS (response = 50% reduction on POD 3; remission <=10)", "day": 3, "form": "count", "definition": "MADRS response, ≥ 50 % reduction from baseline (events are responders, not participants with depression)", "location": "Table 2 (MADRS-based response at postoperative day 3); Results 3.1", "values": { "Esketamine": { "events": "14", "n": "52" }, "Placebo (20 mL normal saline)": { "events": "7", "n": "52" } }, "counts": "improvement" } ], "pain": [ { "measure": "NRS pain at 48 h (severe pain = any NRS >=7)", "day": 2, "form": "count", "definition": "severe pain, any NRS ≥ 7 (Methods: pain evaluated at 48 postoperative hours; Table 2 row 'Servere pain within 72 h'; text: no patient had a postoperative NRS ≥ 7)", "location": "Table 2 (Servere pain within 72 h); Results 3.1 (no patient in either group had a postoperative NRS ≥ 7)", "values": { "Esketamine": { "events": "0", "n": "52" }, "Placebo (20 mL normal saline)": { "events": "0", "n": "52" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine": { "dizziness": "21", "hallucination": "0", "visual": "1", "dissociation": "0" }, "Placebo (20 mL normal saline)": { "dizziness": "16", "hallucination": "0", "visual": "0", "dissociation": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-09-06", "end": "2024-07-08" }, "registration": { "number": "ChiCTR2300071062", "date": "2023-05-04" }, "note": "108 randomized (54 per arm); surgery was cancelled in 4, leaving 52 per arm in the modified intention-to-treat analysis (last observation carried forward). RESPONSE, NOT DEPRESSION: postoperative MADRS is reported only as response (≥ 50 % reduction from baseline), the opposite direction to a count of depressed participants. Day 3: Table 2 14 (27) vs 7 (13), OR 2.37 (0.87 to 6.47); text 27 % (14/52) vs 13 % (7/52), odds ratio 2.4 [0.9 to 6.6]; Table 2 footnote b says two patients were missing at day 3, but the counts are printed over 52. With missing data imputed: 13 (25) vs 7 (13), OR 2.14 (0.78 to 5.91), not coded. Day 1 is from the text: 'the esketamine group had a significantly higher proportion of responders (33 %) than the placebo group (15 %) (odds ratio 2.7, 95 % CI, 1.0 to 6.9)', esketamine versus placebo; counts are not printed, so it is entered as a difference, and its n is the 52 per arm of the modified intention-to-treat population that Fig. 2's caption says the response analyses used, not a number printed beside the estimate. Not coded because not tied to a day: GLMM group main effects for response OR 5.95 (0.49 to 71.71) and remission OR 1.45 (0.13 to 16.25), and MMRM group main effects for MADRS scores MD -0.08 (−1.83 to 1.67) and change from baseline MD -2.54 (−4.47 to −0.61). MADRS by visit (postoperative days 1 to 5, 4 and 12 weeks) is only in Fig. 3 and the supplement, without printed values. PHQ-9 is not in the design and is reported only at baseline (Table 1, median (IQR): 10.00 (8.00, 12.00) vs 10.00 (7.75, 12.00)); not entered. Severe pain: the Methods evaluate pain at 48 postoperative hours with severe pain as any NRS ≥ 7; Table 2's row is 'Servere pain within 72 h' (0 vs 0) and the text says no patient in either group had a postoperative NRS ≥ 7, which includes 48 h, so it is coded as day 2. NRS scores are only in eTable 6. Adverse events (Table 3, within 3 postoperative days): diplopia coded as visual and Dissociative (CADSS ≠ 0) as dissociation; Delirium (3D-CAM) 2 (4) vs 1 (2) not coded (daily postoperative delirium screening, not emergence agitation); manic (YMRS ≥ 5) and psychotic (BPRS) symptoms 0 vs 0 are not codebook categories.", "decided_by": "third reader" }, { "trial": "T094", "source": "fulltext", "arms": { "Control group": { "randomized": "100", "analysed": "100" }, "Esketamine group": { "randomized": "100", "analysed": "100" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "mean_sd", "location": "Table 1 (HADS-D score)", "values": { "Control group": { "mean": "8.2", "sd": "2.4", "n": "100" }, "Esketamine group": { "mean": "8.1", "sd": "2.5", "n": "100" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "location": "Table 4", "values": { "Control group": { "dizziness": "9", "dissociation": "3" }, "Esketamine group": { "dizziness": "6", "dissociation": "15" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR2400087795", "date": null }, "note": "Postoperative HADS-D (days 1 and 3), VAS at 24 and 48 h, opioid consumption, rescue analgesia rate and non-opioid analgesic use appear only in Fig. 2 (no printed values) and as P values, so only the preoperative HADS-D (collected one day before surgery, Table 1) is entered. Analysed = the tables' n (100 per group); no losses reported. The adverse-event period is not stated (listed among the data collected), so window 'overall'; 'Dizziness or Lightheadedness' coded as dizziness and 'Dissociative Symptoms' as dissociation; nausea or vomiting, headache and sedation are not psychotomimetic categories. No enrollment dates in the text.", "decided_by": "both coders" }, { "trial": "T095", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "154", "analysed": "154" }, "Control group": { "randomized": "154", "analysed": "154" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Esketamine group": { "median": "5", "q1": "2", "q3": "10", "n": "154" }, "Control group": { "median": "5", "q1": "2", "q3": "9", "n": "154" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "count", "definition": "EPDS > 10", "location": "Table 2", "values": { "Esketamine group": { "events": "24", "n": "154" }, "Control group": { "events": "37", "n": "154" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "5", "q1": "1.75", "q3": "8", "n": "154" }, "Control group": { "median": "5", "q1": "3", "q3": "9", "n": "154" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 42, "form": "count", "definition": "EPDS > 10", "location": "Table 2", "values": { "Esketamine group": { "events": "16", "n": "154" }, "Control group": { "events": "30", "n": "154" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 42, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "5", "q1": "2", "q3": "7", "n": "154" }, "Control group": { "median": "6", "q1": "3", "q3": "9", "n": "154" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Results, Efficacy Outcomes text (Figure 2A)", "values": { "Esketamine group": { "median": "1", "q1": "1", "q3": "2", "n": null }, "Control group": { "median": "1", "q1": "1", "q3": "2", "n": null } } }, { "measure": "NRS at rest", "day": 2, "form": "median_iqr", "location": "Results, Efficacy Outcomes text (Figure 2A)", "values": { "Esketamine group": { "median": "1", "q1": "1", "q3": "1", "n": null }, "Control group": { "median": "1", "q1": "0.75", "q3": "1", "n": null } } }, { "measure": "NRS with movement", "day": 1, "form": "median_iqr", "location": "Results, Efficacy Outcomes text (Figure 2B)", "values": { "Esketamine group": { "median": "3", "q1": "3", "q3": "3", "n": null }, "Control group": { "median": "3", "q1": "3", "q3": "3", "n": null } } }, { "measure": "NRS with movement", "day": 2, "form": "median_iqr", "location": "Results, Efficacy Outcomes text (Figure 2B)", "values": { "Esketamine group": { "median": "2", "q1": "2", "q3": "3", "n": null }, "Control group": { "median": "2", "q1": "2", "q3": "3", "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "values": { "Esketamine group": { "dizziness": "28", "dissociation": "9", "hallucination": "4", "nightmare": "16", "visual": "1", "any_ae": "65" }, "Control group": { "dizziness": "3", "dissociation": "0", "hallucination": "0", "nightmare": "0", "visual": "0", "any_ae": "12" } } }, { "window": "postoperative", "values": { "Esketamine group": { "dizziness": "8", "any_ae": "23" }, "Control group": { "dizziness": "5", "any_ae": "14" } } } ], "blinding_check": null, "enrollment": { "start": "2023-03", "end": "2024-02" }, "registration": null, "note": "PPD counts use the primary definition, printed as EPDS > 10; but the sensitivity row 'EPDS score ≥11' gives different counts (1 wk 24 vs 31; 6 wk 13 vs 24) and the text calls 10 or higher the common cutoff, so the primary count may be EPDS ≥ 10. Other sensitivity counts (Table 2, esketamine vs control): ≥ 9: 1 wk 32 vs 41, 6 wk 26 vs 45; ≥ 12: 1 wk 15 vs 23, 6 wk 8 vs 18. Timing of the baseline EPDS (Table 1) is not stated; antenatal depression (42 vs 36, definition not given) is not coded. Pain values are printed in the Results text (Figure 2 has no printed values); n not given. PCIA consumption (75.55 [5.81] vs 76.40 [6.06] mL) and bolus use are totals, not at 24 or 48 h, and are left out. Adverse events (Table 3): 'At end of surgery' coded intraoperative (asked at the end of surgery; patients awake under neuraxial anesthesia; infusion after delivery); 'mental trance state' coded dissociation, 'dreamscape' (a dreamlike scene during surgery) coded nightmare, diplopia coded visual; 'Total' rows coded any_ae, though each equals the sum of its rows and may count events rather than patients. 'Within 3 d post partum' coded postoperative. From 3 d to 6 wk post partum (total 16 vs 9; anxiety 7 vs 2) not coded. Enrollment is from Methods (conducted March 2023 to February 2024). No registration number in the text.", "decided_by": "both coders" }, { "trial": "T096", "source": "fulltext", "arms": { "Ketamine group": { "randomized": null, "analysed": "18" }, "Placebo group (normal saline in apple juice)": { "randomized": null, "analysed": "17" } }, "depression": [ { "measure": "PHQ-9", "day": -1, "form": "median_iqr", "location": "Table 2 (PHQ-9 Scores, Preoperative)", "values": { "Ketamine group": { "median": "7.5", "q1": "3.75", "q3": "9.75", "n": null }, "Placebo group (normal saline in apple juice)": { "median": "7", "q1": "3", "q3": "17", "n": null } } }, { "measure": "PHQ-9", "day": 7, "form": "median_iqr", "location": "Table 2 (PHQ-9 Scores, POD7); n from Results text", "values": { "Ketamine group": { "median": "2", "q1": "2", "q3": "5", "n": "15" }, "Placebo group (normal saline in apple juice)": { "median": "3", "q1": "1.75", "q3": "5", "n": "14" } } }, { "measure": "PHQ-9", "day": 30, "form": "median_iqr", "location": "Table 2 (PHQ-9 Scores, POD30); n from Results text", "values": { "Ketamine group": { "median": "7", "q1": "4", "q3": "12.5", "n": "13" }, "Placebo group (normal saline in apple juice)": { "median": "5", "q1": "2.5", "q3": "8", "n": "13" } } } ], "pain": [ { "measure": "NRS pain intensity (maximum, minimum, average over past 24 h)", "day": 1, "form": "median_iqr", "location": "Table 2 (Pain Intensity Scale Scores, POD1)", "values": { "Ketamine group": { "median": "5", "q1": "3.75", "q3": "7.25", "n": null }, "Placebo group (normal saline in apple juice)": { "median": "6", "q1": "5", "q3": "8", "n": null } } }, { "measure": "Opioid use (inpatient administration record; average daily use at follow-up calls), morphine equivalents", "day": 1, "form": "median_iqr", "location": "Table 2 (Postoperative Opioid Use (MED), POD1 (Intravenous + Oral))", "values": { "Ketamine group": { "median": "112.75", "q1": "64.5", "q3": "222.75", "n": null }, "Placebo group (normal saline in apple juice)": { "median": "125", "q1": "103.5", "q3": "202.5", "n": null } } }, { "measure": "Opioid use (inpatient administration record; average daily use at follow-up calls), morphine equivalents", "day": 2, "form": "median_iqr", "location": "Table 2 (Postoperative Opioid Use (MED), POD2 (Intravenous + Oral))", "values": { "Ketamine group": { "median": "61.25", "q1": "25", "q3": "92.5", "n": null }, "Placebo group (normal saline in apple juice)": { "median": "99", "q1": "39", "q3": "126.75", "n": null } } } ], "adverse_events": [], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT04646694", "date": "2020-11-30" }, "note": "40 were randomized in total (per-arm numbers not printed); 5 were excluded after randomization for not meeting inclusion criteria, leaving 18 ketamine and 17 placebo analysed. The n at POD 7 (15, 14) and POD 30 (13, 13) come from the Results text; preoperative and POD 1 n are not printed for Table 2 (Table 1 lists 18 and 17). PHQ-9 was planned at POD 1 but Table 2 reports it only preoperatively, at POD 7 and at POD 30. The pain intensity row does not say whether it is the maximum, minimum or average NRS. Opioid use is coded as the intravenous + oral total for POD 1 and for POD 2 (each day's use, morphine equivalents); components: POD 1 intravenous 99 (48.75–178.5) vs 87 (72–164.25), oral 25 (3.75–56.625) vs 30 (0–55); POD 2 intravenous 0 (0–63.75) vs 0 (0–69), oral 26.5 (13.75–71.25) vs 40 (32.5–102.5). PROMIS pain interference is reported only preoperatively, at POD 7 and at POD 30. Side effects are reported only as Generic Assessment of Side Effects Scale scores (POD 1: 2 (0–7.5) vs 3 (0–6); POD 3: 0 (0−12) vs 0.5 (0–3.75)) and psychotomimetic effects only as not significantly different, so no counts are coded. Enrollment: 'over a 3 year period', no dates given.", "decided_by": "both coders" }, { "trial": "T097", "source": "fulltext", "arms": { "Post-ESK group": { "randomized": "40", "analysed": "37" }, "Pre-ESK group": { "randomized": "40", "analysed": "40" }, "Placebo group": { "randomized": "40", "analysed": "36" } }, "depression": [ { "measure": "PHQ-9", "day": -1, "form": "mean_sd", "location": "Table 2 (Preoperative)", "values": { "Post-ESK group": { "mean": "3.3", "sd": "1.3", "n": "37" }, "Pre-ESK group": { "mean": "3.4", "sd": "1.8", "n": "40" }, "Placebo group": { "mean": "3.3", "sd": "1.6", "n": "36" } } }, { "measure": "PHQ-9", "day": -1, "form": "count", "definition": "PHQ-9 > 9", "location": "Table 3 (Preoperative)", "values": { "Post-ESK group": { "events": "0", "n": "37", "bands": { "0–4": "30", "5–9": "7", "> 9": "0" } }, "Pre-ESK group": { "events": "1", "n": "40", "bands": { "0–4": "33", "5–9": "6", "> 9": "1" } }, "Placebo group": { "events": "0", "n": "36", "bands": { "0–4": "31", "5–9": "5", "> 9": "0" } } } }, { "measure": "PHQ-9", "day": 1, "form": "mean_sd", "location": "Table 2 (POD1)", "values": { "Post-ESK group": { "mean": "5.2", "sd": "2.2", "n": "37" }, "Pre-ESK group": { "mean": "3.9", "sd": "1.3", "n": "40" }, "Placebo group": { "mean": "5.7", "sd": "3.1", "n": "36" } } }, { "measure": "PHQ-9", "day": 1, "form": "count", "definition": "PHQ-9 > 9", "location": "Table 3 (POD1)", "values": { "Post-ESK group": { "events": "1", "n": "37", "bands": { "0–4": "15", "5–9": "21", "> 9": "1" } }, "Pre-ESK group": { "events": "0", "n": "40", "bands": { "0–4": "28", "5–9": "12", "> 9": "0" } }, "Placebo group": { "events": "5", "n": "36", "bands": { "0–4": "17", "5–9": "14", "> 9": "5" } } } }, { "measure": "PHQ-9", "day": 2, "form": "mean_sd", "location": "Table 2 (POD2)", "values": { "Post-ESK group": { "mean": "3.1", "sd": "1.4", "n": "37" }, "Pre-ESK group": { "mean": "2.5", "sd": "1.7", "n": "40" }, "Placebo group": { "mean": "3.4", "sd": "1.4", "n": "36" } } }, { "measure": "PHQ-9", "day": 2, "form": "count", "definition": "PHQ-9 > 9", "location": "Table 3 (POD2)", "values": { "Post-ESK group": { "events": "0", "n": "37", "bands": { "0–4": "30", "5–9": "7", "> 9": "0" } }, "Pre-ESK group": { "events": "0", "n": "40", "bands": { "0–4": "36", "5–9": "4", "> 9": "0" } }, "Placebo group": { "events": "0", "n": "36", "bands": { "0–4": "28", "5–9": "8", "> 9": "0" } } } } ], "pain": [ { "measure": "VAS pain score", "day": 1, "form": "mean_sd", "location": "Table 5 (On POD1, VAS score)", "values": { "Post-ESK group": { "mean": "2.9", "sd": "1.4", "n": "37" }, "Pre-ESK group": { "mean": "2.4", "sd": "1.4", "n": "40" }, "Placebo group": { "mean": "3.5", "sd": "1.8", "n": "36" } } }, { "measure": "VAS pain score", "day": 2, "form": "mean_sd", "location": "Table 5 (On POD2, VAS score)", "values": { "Post-ESK group": { "mean": "1.5", "sd": "0.8", "n": "37" }, "Pre-ESK group": { "mean": "1.1", "sd": "0.7", "n": "40" }, "Placebo group": { "mean": "1.4", "sd": "0.8", "n": "36" } } }, { "measure": "PCA pump presses (sufentanil/oxycodone pump)", "day": 1, "form": "mean_sd", "unit": "presses", "location": "Table 5 (On POD1, PCIA compression time)", "values": { "Post-ESK group": { "mean": "9.9", "sd": "7.9", "n": "37" }, "Pre-ESK group": { "mean": "7.6", "sd": "8.0", "n": "40" }, "Placebo group": { "mean": "13.4", "sd": "12.1", "n": "36" } } }, { "measure": "PCA pump presses (sufentanil/oxycodone pump)", "day": 2, "form": "mean_sd", "unit": "presses", "location": "Table 5 (On POD2, PCIA compression time)", "values": { "Post-ESK group": { "mean": "13.2", "sd": "9.3", "n": "37" }, "Pre-ESK group": { "mean": "11.0", "sd": "10.8", "n": "40" }, "Placebo group": { "mean": "17.4", "sd": "15.4", "n": "36" } } } ], "adverse_events": [ { "window": "postoperative", "time": "not stated (first row of Table 7, before the POD 1 rows)", "location": "Table 7", "values": { "Post-ESK group": { "hallucination": "0" }, "Pre-ESK group": { "hallucination": "2" }, "Placebo group": { "hallucination": "0" } } }, { "window": "postoperative", "time": "POD 1", "location": "Table 7", "values": { "Post-ESK group": { "dizziness": "17" }, "Pre-ESK group": { "dizziness": "16" }, "Placebo group": { "dizziness": "17" } } }, { "window": "postoperative", "time": "POD 2", "location": "Table 7", "values": { "Post-ESK group": { "dizziness": "2" }, "Pre-ESK group": { "dizziness": "1" }, "Placebo group": { "dizziness": "2" } } } ], "blinding_check": null, "enrollment": { "start": "2021-09", "end": "2023-05" }, "registration": { "number": "ChiCTR2100050874", "date": "2021-09-05" }, "note": "120 were randomized, 40 per group (Methods). Results: 2 excluded for postoperative bleeding and fever and 5 for haemolysed blood samples; Table 1's column headers give the analysed numbers, Placebo (36), Pre-ESK (40), Post-ESK (37), used as n for every outcome (Tables 2, 3, 5 and 7 print no n; Table 3's bands add up to these numbers at each time and its percentages use them). Tables list Placebo, Pre-ESK, Post-ESK in that order; Table 2's significance superscripts are dropped. Preoperative values (the day before surgery) are entered as day -1. The Statistical analysis says continuous data are mean and SD. PHQ-9 counts: Table 3 gives bands 0-4, 5-9 and > 9 at each time; the count entries use the > 9 band as printed (definition 'PHQ-9 > 9'), and every band is kept under 'bands'. The paper calls 0-4 'no depressive symptoms', so its own 'depressive symptoms' is PHQ-9 ≥ 5 (bands 5-9 plus > 9), never printed as one number. Pain: the design's 'PCA pump presses' is entered from 'PCIA compression time' (all presses). Table 5's 'PCIA effective compression time' (valid presses, outside the lockout) is not a design measure and is not entered: POD1 Placebo 11.3 ± 8.9, Pre-ESK 6.4 ± 5.9, Post-ESK 8.6 ± 6.4; POD2 14.6 ± 11.8, 9.4 ± 8.5, 11.2 ± 7.0. Whether the POD2 press counts are cumulative or for that day alone is not stated. QoR-15 is not entered. Adverse events (Table 7, 'Postoperative complications'): hallucination has no time (its row sits above the POD 1 and POD 2 rows); dizziness is given separately on POD 1 and POD 2, and a patient may be counted on both days; nausea and vomiting are also reported but are not codebook categories. Enrollment: the Results give no dates; the Methods say the study took place between September 2021 and May 2023. The registration date, printed 05/09/2021, is read as day/month (5 September 2021), consistent with the study starting in September 2021. Esketamine 0.2 mg/kg IV within 10 min after induction (Post-ESK) or 2 h before induction (Pre-ESK); placebo saline after induction; general anaesthesia.", "decided_by": "third reader" }, { "trial": "T099", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "102", "analysed": "102" }, "Saline group": { "randomized": "102", "analysed": "102" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "102" }, "Saline group": { "median": "3", "q1": "2", "q3": "3", "n": "102" } } }, { "measure": "HADS-D", "day": 1, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "102" }, "Saline group": { "median": "3", "q1": "2", "q3": "3", "n": "102" } } }, { "measure": "HADS-D", "day": 2, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "102" }, "Saline group": { "median": "2.5", "q1": "2", "q3": "3", "n": "102" } } }, { "measure": "HADS-D", "day": 3, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "102" }, "Saline group": { "median": "3", "q1": "2", "q3": "3", "n": "102" } } }, { "measure": "HADS-D", "day": 7, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "101" }, "Saline group": { "median": "3", "q1": "2", "q3": "3", "n": "100" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "4", "n": "102" }, "Saline group": { "median": "4", "q1": "3", "q3": "4", "n": "102" } } }, { "measure": "NRS at rest", "day": 2, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "2", "q1": "2", "q3": "3", "n": "102" }, "Saline group": { "median": "3", "q1": "2", "q3": "3", "n": "102" } } }, { "measure": "NRS after movement", "day": 1, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "3", "q1": "3", "q3": "4", "n": "102" }, "Saline group": { "median": "4", "q1": "3", "q3": "4", "n": "102" } } }, { "measure": "NRS after movement", "day": 2, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "2", "q1": "1", "q3": "3", "n": "102" }, "Saline group": { "median": "3", "q1": "2", "q3": "3", "n": "102" } } } ], "adverse_events": [ { "window": "postoperative", "time": "within 1 h after surgery", "location": "Table 4", "values": { "Esketamine group": { "dizziness": "25", "agitation": "2", "hallucination": "0", "visual": "0" }, "Saline group": { "dizziness": "19", "agitation": "0", "hallucination": "0", "visual": "0" } } }, { "window": "postoperative", "time": "1–24 h after surgery", "location": "Table 4", "values": { "Esketamine group": { "dizziness": "14", "agitation": "0", "hallucination": "0", "visual": "0" }, "Saline group": { "dizziness": "11", "agitation": "0", "hallucination": "0", "visual": "0" } } }, { "window": "postoperative", "time": "24–72 h after surgery", "location": "Table 4", "values": { "Esketamine group": { "dizziness": "9", "agitation": "0", "hallucination": "0", "visual": "0" }, "Saline group": { "dizziness": "6", "agitation": "0", "hallucination": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2024-05-05", "end": "2024-10-31", "location": "Methods ('Dates of first and last enrollments were May 5, 2024, and October 31, 2024'); the Results give no dates" }, "registration": { "number": "NCT06388824", "date": null }, "note": "The source calls the saline arm 'Placebo group' (= design 'Saline group'); tables print it first. Esketamine 0.2 mg/kg once, immediately after the start of surgery. 204 randomized, 102 per group; the intention-to-treat analysis includes all 204. Three women declined the day-7 follow-up: Table 3 marks the day-7 values '(2)h' (placebo) and '(1)h' (esketamine), 'patients with missing data owing to refused assessment', and prints the per-protocol n as 100 (placebo) and 101 (esketamine); missing data were not imputed, so the day-7 HADS-D n is 100 and 101. Other n are the column n (102). HADS-D and NRS are median (IQR); Hodges-Lehmann median differences are also printed (HADS-D 0 (0 to 0) at each day; not entered since arm values are given). NRS at postoperative hour 1 falls outside the day windows. Acetaminophen use over the first three postoperative days (placebo 13 (12.8), esketamine 6 (5.9)) has no day 1 or 2 value, so it is not entered. Adverse events from Table 4, whose 'Postoperative period' has three sub-periods, each entered as postoperative with its time: within 1 h after surgery (which spans emergence from the brief propofol anaesthesia, though the source never calls it emergence), 1–24 h and 24–72 h after surgery. Agitation is Table 4's 'Agitation' row only; delirium (within 1 h: placebo 1 (1.0), esketamine 4 (3.9); 0 later), somnolence and memory impairment are separate rows, not added or mapped; visual = diplopia. No codebook category in the intraoperative period. Text: no serious side effects. Enrollment is from the Methods (the Results give no dates). No blinding check reported.", "decided_by": "third reader" }, { "trial": "T100", "source": "fulltext", "arms": { "Esketamine group (PE)": { "randomized": "66", "analysed": "58" }, "Control group (C)": { "randomized": "66", "analysed": "58" } }, "depression": [ { "measure": "HADS depression score", "day": 1, "form": "difference", "location": "Discussion, second paragraph", "estimate": "1.5", "lower": null, "upper": null, "level": null, "scale": null, "comparison": "Control group (C) minus Esketamine group (PE): 'HADS-D scores were 1.5 points lower in group PE'", "p": "< 0.05", "values": { "Esketamine group (PE)": { "n": "58" }, "Control group (C)": { "n": "58" } }, "direction": "lower in Esketamine group (PE) than in Control group (C)" }, { "measure": "HADS depression score", "day": 3, "form": "difference", "location": "Discussion, second paragraph", "estimate": "1.5", "lower": null, "upper": null, "level": null, "scale": null, "comparison": "Control group (C) minus Esketamine group (PE): 'HADS-D scores were 1.5 points lower in group PE'", "p": "< 0.05", "values": { "Esketamine group (PE)": { "n": "58" }, "Control group (C)": { "n": "58" } }, "direction": "lower in Esketamine group (PE) than in Control group (C)" } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Results, text ('no patients in either group developed headache, blurred vision, delirium, or block-related complications')", "values": { "Esketamine group (PE)": { "visual": "0" }, "Control group (C)": { "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-09", "end": "2024-02", "location": "Methods (patients scheduled between September 2023 and February 2024 were included); the Results give no dates" }, "registration": { "number": "ChiCTR2300075055", "date": "2023-08-23" }, "note": "Tables 1-7 are not reproduced in the source (web 'Download CSV / Display Table' placeholders) and Figures 2-3 print no values, so no arm-level HADS-D, VAS or adverse-event counts are available. Results: HADS-D lower in group PE on postoperative days 1 and 3 (p < 0.05), no difference preoperatively or on day 7 (p > 0.05). The only depression number is the Discussion's 'Compared with group C, HADS-D scores were 1.5 points lower in group PE', given once for days 1 and 3 together; it is entered at both days as printed (1.5, control minus esketamine), but it is not said whether it applies to each day or is one figure for both, nor whether it is a mean or median difference (HADS analysed by repeated-measures ANOVA), so scale is null; no CI or exact p. Arm n = 58 per group from the notes to Figures 2 and 3 (116 completed with complete data). 132 randomized (66 per group), 16 dropped out. Group C is the 'placebo group'. Esketamine 0.5 mg/kg at induction plus 1 mg/kg in a 48 h PCIA. VAS (Table 5) and RASS: no values. Adverse events: only the zero for blurred vision is printed in words ('no patients in either group developed headache, blurred vision, delirium...'), recorded as visual 0; Table 7's postoperative agitation, hallucination and dizziness counts are not in the source, and delirium (none) is a separate item from postoperative agitation, so agitation is not entered. Enrollment from the Methods; the Results give no dates. Registration date printed 'August 23, 2023'. No blinding check.", "decided_by": "third reader" }, { "trial": "T101", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "90", "analysed": "86" }, "Placebo group": { "randomized": "90", "analysed": "87" } }, "depression": [ { "measure": "PHQ-8", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative status, PHQ-8 score)", "values": { "Esketamine group": { "median": "6", "q1": "5", "q3": "9", "n": "86" }, "Placebo group": { "median": "7.0", "q1": "4", "q3": "10", "n": "87" } } }, { "measure": "PHQ-8", "day": 3, "form": "median_iqr", "location": "Table 3 (PHQ-8 score POD3)", "values": { "Esketamine group": { "median": "5", "q1": "3", "q3": "8", "n": "86" }, "Placebo group": { "median": "5", "q1": "3", "q3": "8", "n": "87" } } }, { "measure": "PHQ-8", "day": 30, "form": "median_iqr", "location": "Table 3 (PHQ-8 score POD30)", "values": { "Esketamine group": { "median": "5", "q1": "2", "q3": "8" }, "Placebo group": { "median": "6", "q1": "3", "q3": "10" } } } ], "pain": [ { "measure": "NRS pain", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS score at rest POD1)", "values": { "Esketamine group": { "median": "1", "q1": "0", "q3": "2" }, "Placebo group": { "median": "1", "q1": "0", "q3": "2" } } }, { "measure": "NRS pain", "day": 2, "form": "median_iqr", "location": "Table 3 (NRS score at rest POD2)", "values": { "Esketamine group": { "median": "0", "q1": "0", "q3": "1" }, "Placebo group": { "median": "0", "q1": "0", "q3": "1" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2024-08-05", "end": "2025-06-30" }, "registration": { "number": "NCT06530706", "date": "2024-07-31" }, "note": "180 randomized (90 and 90); 88 per arm received the allocated intervention; 86 and 87 analysed (primary endpoint data). PHQ-8 baseline from Table 1 'Preoperative status' (collected after consent, before surgery). Table 3 adjusted mean differences (ANCOVA): PHQ-8 POD3 0 (−1 to 1), POD30 −2 (−3 to −1). POD30 n is left out: Table 3's header says n=86 and n=87, but HAMA ≤ 7 at POD30 has denominators 84 and 85. The design lists one pain measure, 'NRS pain'; the source reports NRS at rest and at cough (Table 3, exploratory): rest is entered as 'NRS pain'; cough is not a measure the design lists, so it is not entered (Table 3, esketamine vs placebo, median [IQR]: POD1 3 [1, 4] vs 2 [1, 4]; POD2 2 [1, 3] vs 2 [1, 3]). The pain n is left out because Table 4's POD1 and POD2 nausea denominators are 84 and 85 in the esketamine group. NRS after extubation 0 [0, 2] in both groups (day 0) not entered. No psychotomimetic adverse events are reported: Table 4 covers hypotension, vasopressors, hypertension, antihypertensives, nausea and vomiting, and 'No serious adverse events were reported in either group'. Enrollment from the Results ('from 5 Aug, 2024 to 30 Jun, 2025').", "decided_by": "third reader" }, { "trial": "T102", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "80", "analysed": "70" }, "Normal saline control group": { "randomized": "80", "analysed": "70" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Esketamine group": { "median": "8", "q1": "6", "q3": "9", "n": "70" }, "Normal saline control group": { "median": "8", "q1": "6", "q3": "9", "n": "70" } } }, { "measure": "EPDS", "day": 3, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "6", "q1": "5", "q3": "9", "n": "70" }, "Normal saline control group": { "median": "8", "q1": "6", "q3": "10", "n": "70" } } }, { "measure": "EPDS", "day": 7, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "7", "q1": "5", "q3": "8.25", "n": "70" }, "Normal saline control group": { "median": "8", "q1": "5", "q3": "12", "n": "70" } } }, { "measure": "EPDS", "day": 42, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "8", "q1": "6", "q3": "10", "n": "70" }, "Normal saline control group": { "median": "8", "q1": "6.75", "q3": "12", "n": "70" } } }, { "measure": "EPDS", "day": 3, "form": "count", "definition": "Incidence of postpartum depression (criterion not stated)", "location": "Table 3", "values": { "Esketamine group": { "events": "5", "n": "70" }, "Normal saline control group": { "events": "14", "n": "70" } } }, { "measure": "EPDS", "day": 7, "form": "count", "definition": "Incidence of postpartum depression (criterion not stated)", "location": "Table 3", "values": { "Esketamine group": { "events": "5", "n": "70" }, "Normal saline control group": { "events": "15", "n": "70" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "Incidence of postpartum depression (criterion not stated)", "location": "Table 3", "values": { "Esketamine group": { "events": "11", "n": "70" }, "Normal saline control group": { "events": "14", "n": "70" } } } ], "pain": [ { "measure": "NRS pain", "day": 1, "form": "median_iqr", "location": "Table 4", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "70" }, "Normal saline control group": { "median": "3", "q1": "3", "q3": "3", "n": "70" } } }, { "measure": "NRS pain", "day": 2, "form": "median_iqr", "location": "Table 4", "values": { "Esketamine group": { "median": "2", "q1": "2", "q3": "3", "n": "70" }, "Normal saline control group": { "median": "3", "q1": "2", "q3": "3", "n": "70" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "dizziness": "7", "nightmare": "1", "visual": "2" }, "Normal saline control group": { "dizziness": "5", "nightmare": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2024-01", "end": "2025-08" }, "registration": { "number": "ChiCTR2300078490", "date": null }, "note": "Randomized 80 per arm from Figure 1's printed description ('Esketamine and control groups each had 80 allocated. After follow-up losses, 70 analyzed per group; 3 exclusions in the control group for unauthorized analgesic use'); the text says 160 randomized and Tables give n = 70. Baseline EPDS is the antenatal assessment (Table 1). Table 3 also gives Hodges-Lehmann median differences (control minus esketamine; EPDS 1 (0, 2) at each time) and Newcombe ARRs for postpartum depression; not recorded since arm values are given. The criterion behind 'Incidence of postpartum depression' is not stated (the exclusion criterion used EPDS ≥ 13). The Results text describes Table 4's NRS pain scores as 'during movement'; the 72 h value (day 3) is outside the codebook's days, and the rescue analgesia rate (9 (12.9%) vs 19 (27.1%)) covers 0 to 72 h, so neither recorded. AEs from Table 5 (postoperative complications); nausea and vomiting, shivering, somnolence not coded. Registration date not given.", "decided_by": "both coders" }, { "trial": "T103", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "105", "analysed": "98" }, "Placebo group": { "randomized": "105", "analysed": "100" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative emotional status, HADS-D score)", "values": { "Esketamine group": { "median": "7.0", "q1": "5.0", "q3": "10.0", "n": "98" }, "Placebo group": { "median": "7.0", "q1": "5.0", "q3": "9.0", "n": "100" } } }, { "measure": "HADS-D", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "6.0", "q1": "4.0", "q3": "7.0", "n": "98" }, "Placebo group": { "median": "8.0", "q1": "6.0", "q3": "8.0", "n": "100" } } }, { "measure": "HADS-D", "day": 2, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "5.0", "q1": "3.0", "q3": "6.0", "n": "98" }, "Placebo group": { "median": "7.0", "q1": "5.0", "q3": "8.0", "n": "100" } } }, { "measure": "HADS-D", "day": 3, "form": "median_iqr", "location": "Table 2", "values": { "Esketamine group": { "median": "4.0", "q1": "2.0", "q3": "5.0", "n": "98" }, "Placebo group": { "median": "6.0", "q1": "5.0", "q3": "7.0", "n": "100" } } } ], "pain": [ { "measure": "NRS at rest (24-h average)", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS Scores at rest, POD 1)", "values": { "Esketamine group": { "median": "1.0", "q1": "0.0", "q3": "2.0", "n": "98" }, "Placebo group": { "median": "2.0", "q1": "1.0", "q3": "3.0", "n": "100" } } }, { "measure": "NRS at rest (24-h average)", "day": 2, "form": "median_iqr", "location": "Table 3 (NRS Scores at rest, POD 2)", "values": { "Esketamine group": { "median": "1.0", "q1": "0.0", "q3": "2.0", "n": "98" }, "Placebo group": { "median": "2.0", "q1": "1.0", "q3": "3.0", "n": "100" } } }, { "measure": "NRS during movement (24-h average)", "day": 1, "form": "median_iqr", "location": "Table 3 (NRS scores during movement, POD 1)", "values": { "Esketamine group": { "median": "4.0", "q1": "3.0", "q3": "5.0", "n": "98" }, "Placebo group": { "median": "5.0", "q1": "3.0", "q3": "6.0", "n": "100" } } }, { "measure": "NRS during movement (24-h average)", "day": 2, "form": "median_iqr", "location": "Table 3 (NRS scores during movement, POD 2)", "values": { "Esketamine group": { "median": "3.0", "q1": "3.0", "q3": "4.0", "n": "98" }, "Placebo group": { "median": "4.0", "q1": "3.0", "q3": "5.0", "n": "100" } } }, { "measure": "BPI pain severity and interference", "item": "pain severity (BPI pain items)", "day": 1, "form": "median_iqr", "location": "Table 3 (BPI pain items, POD 1)", "values": { "Esketamine group": { "median": "2.0", "q1": "1.0", "q3": "3.5", "n": "98" }, "Placebo group": { "median": "3.8", "q1": "1.8", "q3": "4.0", "n": "100" } } }, { "measure": "BPI pain severity and interference", "item": "pain severity (BPI pain items)", "day": 2, "form": "median_iqr", "location": "Table 3 (BPI pain items, POD 2)", "values": { "Esketamine group": { "median": "1.8", "q1": "1.0", "q3": "2.8", "n": "98" }, "Placebo group": { "median": "3.0", "q1": "1.8", "q3": "3.5", "n": "100" } } }, { "measure": "BPI pain severity and interference", "item": "interference (BPI interference items)", "day": 1, "form": "median_iqr", "location": "Table 3 (BPI interference items, POD 1)", "values": { "Esketamine group": { "median": "4.0", "q1": "3.7", "q3": "4.4", "n": "98" }, "Placebo group": { "median": "5.0", "q1": "4.0", "q3": "5.3", "n": "100" } } }, { "measure": "BPI pain severity and interference", "item": "interference (BPI interference items)", "day": 2, "form": "median_iqr", "location": "Table 3 (BPI interference items, POD 2)", "values": { "Esketamine group": { "median": "3.3", "q1": "3.1", "q3": "3.6", "n": "98" }, "Placebo group": { "median": "4.0", "q1": "3.7", "q3": "4.4", "n": "100" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "nightmare": "6" }, "Placebo group": { "nightmare": "4" } } } ], "blinding_check": null, "enrollment": { "start": "2024-10", "end": "2025-01" }, "registration": { "number": "ChiCTR2400088916", "date": "2024-08-29" }, "note": "Randomized 105 per group; 7 esketamine (3 conversions to laparotomy, 4 ICU stays with intubation > 24 h) and 5 placebo (2 conversions, 3 ICU stays) excluded, leaving the mITT population of 98 and 100 used in every table. Figure 1's caption adds 97 esketamine in the per-protocol set and '2 lost to follow-up' without saying which group. Table 2 gives HADS-D as median (lower quartile, upper quartile), with a median-difference (95% CI) column not recorded since arm values are given. Figure 3's description gives approximate HADS-D values read off the line graph; not used. Pain is the average over the previous 24 h on each POD (Methods 2.6); POD 3 values are left out as day 3. The design names one measure 'BPI pain severity and interference'; Table 3 reports 'BPI pain items' and 'BPI interference items' separately, so both are recorded under the design's name with an 'item' field telling them apart. Adverse events: Table 4's drug-related complications were assessed within 7 days after surgery; only nightmares are a codebook category (PONV 17 vs 28, headache 34 vs 30, sleepiness 19 vs 15, constipation 8 vs 7, esketamine vs placebo, are not). Enrollment dates are from Methods 2.2 (screening October 2024 to January 2025); the Results don't restate them.", "decided_by": "both coders" }, { "trial": "T104", "source": "fulltext", "arms": { "N group (saline)": { "randomized": "35", "analysed": null }, "A group (esketamine)": { "randomized": "35", "analysed": null } }, "depression": [ { "measure": "Zung SDS", "day": -1, "form": "mean_sd", "location": "Table 3", "values": { "N group (saline)": { "mean": "46.0", "sd": "8.7", "n": null }, "A group (esketamine)": { "mean": "46.0", "sd": "8.2", "n": null } } }, { "measure": "Zung SDS", "day": 1, "form": "mean_sd", "location": "Table 3", "values": { "N group (saline)": { "mean": "52.5", "sd": "9.7", "n": null }, "A group (esketamine)": { "mean": "49.0", "sd": "8.8", "n": null } } }, { "measure": "Zung SDS", "day": 2, "form": "mean_sd", "location": "Table 3", "values": { "N group (saline)": { "mean": "50.0", "sd": "9.0", "n": null }, "A group (esketamine)": { "mean": "47.5", "sd": "8.4", "n": null } } } ], "pain": [], "adverse_events": [ { "window": "emergence", "values": { "N group (saline)": { "agitation": "11" }, "A group (esketamine)": { "agitation": "8" } } }, { "window": "postoperative", "values": { "N group (saline)": { "psychiatric_any": "0" }, "A group (esketamine)": { "psychiatric_any": "5" } } } ], "blinding_check": null, "enrollment": { "start": "2024-05", "end": "2025-12" }, "registration": null, "note": "Secondary analysis of a four-arm randomized study (LA, L, A, N; 35 each); L and LA left out. All 140 were in the safety analysis; efficacy used available cases and no SDS ns are given (QoR-40 POD1 available A 35, N 34; POD7 A 34, N 34), so analysed and n are null. Table columns run LA, L, A, N. SDS (standardized score, mean ± SD) at baseline was the day before surgery (Table 1 gives the same values); POD1 = 24 ± 6 h and POD2 = 48 ± 6 h after extubation. The QoR-40 pain dimension is only in Supplementary Table S1, so there are no pain entries. Emergence agitation = Riker ≥ 5 in PACU. 'Vivid dreams/hallucinations' (asked in PACU and on POD1) is one combined count, coded psychiatric_any. Nu-DESC PACU delirium-like symptoms (A 3, N 4) not coded. Blinding success was not assessed. Enrollment is from Methods (parent study May 2024 to December 2025). No registration in the text.", "decided_by": "both coders" }, { "trial": "T105", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "42", "analysed": "39" }, "Placebo group": { "randomized": "42", "analysed": "38" } }, "depression": [ { "measure": "HADS-D", "day": 1, "form": "median_iqr", "location": "Results, Primary outcome paragraph", "values": { "Esketamine group": { "median": "2", "q1": "1", "q3": "3" }, "Placebo group": { "median": "6", "q1": "5", "q3": "8" } } }, { "measure": "HADS-D", "day": 3, "form": "median_iqr", "location": "Results, Primary outcome paragraph", "values": { "Esketamine group": { "median": "1", "q1": "0", "q3": "2" }, "Placebo group": { "median": "5", "q1": "3", "q3": "6" } } }, { "measure": "HADS-D", "day": 1, "form": "percent", "definition": "HADS-D > 7", "location": "Results, Primary outcome paragraph (also abstract)", "values": { "Esketamine group": { "percent": "7.7" }, "Placebo group": { "percent": "31.6" } } }, { "measure": "HADS-D", "day": 3, "form": "percent", "definition": "HADS-D > 7", "location": "Results, Primary outcome paragraph (also abstract)", "values": { "Esketamine group": { "percent": "0.0" }, "Placebo group": { "percent": "15.8" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "visual": "0", "dizziness": "0", "nightmare": "0" }, "Placebo group": { "visual": "0", "dizziness": "0", "nightmare": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2024-06-04", "end": "2025-08-26" }, "registration": { "number": "ChiCTR2400084537", "date": "2024-05-20" }, "note": "Tables 1-4 and Tables S1-S2 are not in the source (captions and 'Display Table' only), so all values come from the Results prose. Arms: 84 randomized, 42 per group; 77 analysed per protocol (abstract: 39 esketamine, 38 placebo). HADS-D, median [IQR], on POD1 (day 1) and POD3 (day 3); the placebo values print as '6 [ Citation 5–8]' and '5 [ Citation 3–6]' (the web page turned the bracketed ranges into citation links), read as median 6, IQR 5–8 and median 5, IQR 3–6. Median differences −4 (95% CI −5 to −3) on both days are not entered since arm values are given. Depression incidence (HADS-D > 7, the primary outcome) is printed only as percentages, entered in form 'percent' with no events or n (each fits a whole number of the analysed 39 or 38, but no counts are printed); relative risks 0.24 (95% CI 0.08–0.80) on POD1 and 0.00 (0.00–0.47) on POD3 are not entered since arm values are given. n per day not printed. No baseline HADS-D values printed. VAS at rest and with movement, intraoperative morphine equivalents, and rescue analgesia are reported only as not different (Table 3, Figure S1), so no pain entries; intraoperative sufentanil (30 [25–40] vs 35 [30–44] μg) is day 0. AE zeros come from 'None of the patients experienced diplopia, dizziness, nightmares, or loss of intraoperative awareness' (safety outcomes within 48 h). 'Postoperative delirium or scalp hydrops was observed in only one patient in the esketamine group' does not say which event, so agitation is not coded. PONV (4 (10.3%) vs 5 (13.2%)) is not a codebook category. Blinding not assessed: the authors say no allocation-guessing survey was given.", "decided_by": "third reader" }, { "trial": "T106", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "50", "analysed": "50" }, "Control group": { "randomized": "50", "analysed": "50" } }, "depression": [], "pain": [ { "measure": "VAS at rest", "day": 1, "form": "median_iqr", "location": "Table 3 (VAS scores at rest, Postoperative day 1)", "values": { "Esketamine group": { "median": "3", "q1": "3", "q3": "3", "n": "50" }, "Control group": { "median": "3.5", "q1": "3", "q3": "4", "n": "50" } } }, { "measure": "VAS during movement (coughing/deep breathing)", "day": 1, "form": "median_iqr", "location": "Table 3 (VAS scores for movement, Postoperative day 1)", "values": { "Esketamine group": { "median": "3", "q1": "3", "q3": "4", "n": "50" }, "Control group": { "median": "4", "q1": "3", "q3": "4", "n": "50" } } }, { "measure": "hydromorphone intake", "day": 1, "form": "median_iqr", "location": "Table 3 (Consumption of hydromorphone after surgery (mg), 24 h after surgery)", "values": { "Esketamine group": { "median": "5", "q1": "4", "q3": "5", "n": "50" }, "Control group": { "median": "5", "q1": "4.5", "q3": "5", "n": "50" } } }, { "measure": "hydromorphone intake", "day": 2, "form": "median_iqr", "location": "Table 3 (Consumption of hydromorphone after surgery (mg), 48 h after surgery)", "values": { "Esketamine group": { "median": "9", "q1": "8.5", "q3": "9.5", "n": "50" }, "Control group": { "median": "9", "q1": "8.5", "q3": "10", "n": "50" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 3 (Postoperative adverse events, n (%))", "n": { "Esketamine group": "50", "Control group": "50" }, "values": { "Esketamine group": { "dizziness": "1", "nightmare": "0" }, "Control group": { "dizziness": "2", "nightmare": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR2500096036", "date": null }, "note": "The source calls the arms 'Experimental' (esketamine) and 'Control'; Figure 1's caption says 100 randomized, 50 per arm, none lost, all analysed. HADS-D (with HADS-A) on preoperative day 1 and postoperative days 1, 3, and 5 appears only in Figure 4 (median with IQR) with no printed values, so depression is empty. Table 3's 'median (quartile)' values (Methods) are recorded as median_iqr. Experimental VAS during movement on postoperative day 1 is printed '3 (3.4)', read as 3 (3,4), the period taken for the table's comma; the 'VAS scores for movement' heading row also carries a stray '3 (3,3)' in the Experimental column. The Results text cites Table 2 for VAS, but the values are in Table 3 (Table 2's 'NRS score' is a sleep NRS). VAS is not reported on postoperative day 2; VAS immediately after surgery and on postoperative days 3 and 5, and intraoperative opioid consumption, fall outside the day 1 and day 2 windows. Hydromorphone at 24 and 48 h after surgery is coded days 1 and 2. Postoperative delirium (Control 5 (10), Experimental 7 (14)) is not mapped: it is undefined and not described as excitement on emergence, which is what the codebook puts under agitation. Pruritis (0 and 0) and nausea and vomiting (7 vs 5, Control vs Experimental) are not codebook categories. No enrollment dates or registration date given.", "decided_by": "third reader" }, { "trial": "T107", "source": "fulltext", "arms": { "Bolus group": { "randomized": "168", "analysed": "153" }, "Infusion group": { "randomized": "168", "analysed": "156" }, "Control group": { "randomized": "167", "analysed": "150" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 1 (Baseline EPDS scores)", "values": { "Bolus group": { "median": "5", "q1": "2", "q3": "7", "n": "153" }, "Infusion group": { "median": "5", "q1": "2", "q3": "7", "n": "156" }, "Control group": { "median": "4.5", "q1": "1", "q3": "6", "n": "150" } } }, { "measure": "EPDS", "day": 7, "form": "count", "definition": "positive PPD screen, EPDS 'more than 10' as printed in Methods (main rows probably EPDS >= 10; see note)", "location": "Table 2 (PPD, 1 wk)", "values": { "Bolus group": { "events": "16", "n": "147" }, "Infusion group": { "events": "17", "n": "148" }, "Control group": { "events": "22", "n": "145" } } }, { "measure": "EPDS", "day": 7, "form": "median_iqr", "location": "Table 2 (EPDS scores, 1 wk)", "values": { "Bolus group": { "median": "3", "q1": "0", "q3": "6", "n": "147" }, "Infusion group": { "median": "4", "q1": "1", "q3": "6", "n": "148" }, "Control group": { "median": "3", "q1": "0", "q3": "6", "n": "145" } } }, { "measure": "EPDS", "day": 28, "form": "count", "definition": "positive PPD screen, EPDS 'more than 10' as printed in Methods (main rows probably EPDS >= 10; see note)", "location": "Table 2 (PPD, 4 wk)", "values": { "Bolus group": { "events": "18", "n": "150" }, "Infusion group": { "events": "15", "n": "147" }, "Control group": { "events": "23", "n": "145" } } }, { "measure": "EPDS", "day": 28, "form": "median_iqr", "location": "Table 2 (EPDS scores, 4 wk)", "values": { "Bolus group": { "median": "2", "q1": "0", "q3": "6", "n": "150" }, "Infusion group": { "median": "2", "q1": "0", "q3": "7", "n": "147" }, "Control group": { "median": "2", "q1": "0", "q3": "7", "n": "145" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "positive PPD screen, EPDS 'more than 10' as printed in Methods (main rows probably EPDS >= 10; see note)", "location": "Table 2 (PPD, 6 wk)", "values": { "Bolus group": { "events": "14", "n": "153" }, "Infusion group": { "events": "18", "n": "156" }, "Control group": { "events": "29", "n": "150" } } }, { "measure": "EPDS", "day": 42, "form": "median_iqr", "location": "Table 2 (EPDS scores, 6 wk)", "values": { "Bolus group": { "median": "2", "q1": "0", "q3": "5", "n": "153" }, "Infusion group": { "median": "2", "q1": "0", "q3": "5.75", "n": "156" }, "Control group": { "median": "3", "q1": "0", "q3": "7", "n": "150" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Results, Pain Control paragraph (postoperative day 1)", "values": { "Bolus group": { "median": "3", "q1": "2", "q3": "3", "n": null }, "Infusion group": { "median": "3", "q1": "2", "q3": "3", "n": null }, "Control group": { "median": "3", "q1": "2", "q3": "3", "n": null } } }, { "measure": "NRS at rest", "day": 2, "form": "median_iqr", "location": "Results, Pain Control paragraph (day 2)", "values": { "Bolus group": { "median": "1", "q1": "0", "q3": "2", "n": null }, "Infusion group": { "median": "1", "q1": "0", "q3": "2", "n": null }, "Control group": { "median": "1", "q1": "0", "q3": "2", "n": null } } }, { "measure": "NRS with movement (coughing or walking)", "day": 1, "form": "median_iqr", "location": "Results, Pain Control paragraph (postoperative day 1)", "values": { "Bolus group": { "median": "4", "q1": "4", "q3": "5", "n": null }, "Infusion group": { "median": "4", "q1": "4", "q3": "5", "n": null }, "Control group": { "median": "4", "q1": "3", "q3": "5", "n": null } } }, { "measure": "NRS with movement (coughing or walking)", "day": 2, "form": "median_iqr", "location": "Results, Pain Control paragraph (day 2)", "values": { "Bolus group": { "median": "3", "q1": "3", "q3": "4", "n": null }, "Infusion group": { "median": "3", "q1": "3", "q3": "4", "n": null }, "Control group": { "median": "3", "q1": "3", "q3": "4", "n": null } } }, { "measure": "PCIA usage (fentanyl)", "day": 2, "form": "mean_sd", "location": "Results, Pain Control (PCIA paragraph, 'total agent'); Methods (PCIA discontinued within 48 hours postoperatively)", "values": { "Bolus group": { "mean": "69.25", "sd": "12.04", "n": null }, "Infusion group": { "mean": "68.73", "sd": "12.31", "n": null }, "Control group": { "mean": "69.92", "sd": "12.75", "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "location": "Table 3 (During surgery)", "values": { "Bolus group": { "dizziness": "22", "nightmare": "6", "hallucination": "13", "any_ae": "70" }, "Infusion group": { "dizziness": "47", "nightmare": "9", "hallucination": "5", "visual": "0", "any_ae": "102" }, "Control group": { "dizziness": "5", "nightmare": "0", "hallucination": "0", "visual": "0", "any_ae": "33" } } }, { "window": "postoperative", "location": "Table 3 (Within 6 weeks postpartum, In total)", "values": { "Bolus group": { "any_ae": "17" }, "Infusion group": { "any_ae": "23" }, "Control group": { "any_ae": "20" } } } ], "blinding_check": null, "enrollment": { "start": "2024-04", "end": "2025-04" }, "registration": { "number": "ChiCTR2400082919", "date": null }, "note": "Randomized 168 bolus, 168 infusion, 167 control; analysed (per protocol, completed 6 weeks) 153, 156, 150. PPD definition: Methods say 'EPDS scores more than 10', but the Statistical analysis calls >= 10 the usual cut-off, prenatal screening excluded EPDS >= 10, and the sensitivity rows at >= 11 differ from the main rows, so the main rows probably use >= 10. Sensitivity counts (Table 2; control, bolus, infusion), not entered: EPDS >= 11 at 1 wk 16/145, 10/147, 13/148; 4 wk 19/145, 15/150, 11/147; 6 wk 25/150, 8/153, 12/156; EPDS >= 12 at 1 wk 6/145, 8/147, 12/148; 4 wk 12/145, 12/150, 9/147; 6 wk 18/150, 7/153, 9/156. ITT worst-case results (17.85% vs 17.26%, infusion vs bolus) not entered. Table 2 prints no n for the EPDS median rows; their n is the PPD denominator at the same visit. Pain and PCIA values come from the text, which lists three values per time without naming the groups; read in the order control, bolus, infusion, the order of every table (the bolus-attempt percentages in the same section, 50.66% vs 54.90% vs 55.12%, fit denominators 150, 153, 156 in that order). The infusion value at rest on day 1 is printed '3 3 (2–3)'. Day-3 NRS left out (outside days 1-2). PCIA 'total agent' consumption (unit not stated; PCIA of 1 mg fentanyl in 100 mL) is entered at day 2: the PCIA was discontinued within 48 hours, so its total is the cumulative consumption at 48 h; its n is not printed. PCIA bolus frequencies 2 (0–6) vs 2 (0–4) vs 2 (0–5) (IQR or range not said) and bolus-attempt incidence not entered. Adverse events during surgery (asked at the end of surgery under spinal anaesthesia): 'Dreamscape' coded as nightmare; control and infusion print 0 for both diplopia and nystagmus, so their visual count is 0, while the bolus group prints diplopia 1 and nystagmus 1 as separate rows, so its visual count (1 or 2) is not entered. 'In total' rows coded as any_ae; each equals the sum of its rows, so it may count events rather than participants; the 6-week rows hold no psychotomimetic category. Enrollment dates are the trial period in Methods ('between April 2024 and April 2025').", "decided_by": "third reader" }, { "trial": "T108", "source": "fulltext", "arms": { "Esketamine group": { "randomized": null, "analysed": "35" }, "Control group": { "randomized": null, "analysed": "34" } }, "depression": [ { "measure": "HAMD-17", "day": -1, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'Pre-operation: Yes'", "values": { "Esketamine group": { "events": "10", "n": "35" }, "Control group": { "events": "6", "n": "34" } } }, { "measure": "HAMD-17", "day": 1, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'POD 1: Yes'", "values": { "Esketamine group": { "events": "18", "n": "35" }, "Control group": { "events": "18", "n": "34" } } }, { "measure": "HAMD-17", "day": 1, "form": "change_median_iqr", "location": "Table 3, 'POD 1' (postoperative minus preoperative score)", "values": { "Esketamine group": { "median": "3", "q1": "1", "q3": "5", "n": "35" }, "Control group": { "median": "3.5", "q1": "1", "q3": "6.25", "n": "34" } } }, { "measure": "HAMD-17", "day": 3, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'POD 3: Yes'", "values": { "Esketamine group": { "events": "15", "n": "35" }, "Control group": { "events": "16", "n": "34" } } }, { "measure": "HAMD-17", "day": 3, "form": "change_median_iqr", "location": "Table 3, 'POD 3' (postoperative minus preoperative score)", "values": { "Esketamine group": { "median": "1", "q1": "0", "q3": "3", "n": "35" }, "Control group": { "median": "2", "q1": "1", "q3": "5", "n": "34" } } }, { "measure": "HAMD-17", "day": 5, "form": "count", "definition": "HAMD-17 > 7", "location": "Table 2, 'POD 5: Yes'", "values": { "Esketamine group": { "events": "12", "n": "35" }, "Control group": { "events": "11", "n": "34" } } }, { "measure": "HAMD-17", "day": 5, "form": "change_median_iqr", "location": "Table 3, 'POD 5' (postoperative minus preoperative score)", "values": { "Esketamine group": { "median": "0", "q1": "0", "q3": "1", "n": "35" }, "Control group": { "median": "1", "q1": "0", "q3": "2", "n": "34" } } } ], "pain": [ { "measure": "VAS pain", "day": 1, "form": "median_iqr", "location": "Table 4, 'POD 1'", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "4", "n": "35" }, "Control group": { "median": "4", "q1": "3", "q3": "5", "n": "34" } } }, { "measure": "VAS pain", "day": 2, "form": "median_iqr", "location": "Table 4, 'POD 2'", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "3", "n": "35" }, "Control group": { "median": "3", "q1": "2", "q3": "4", "n": "34" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "dizziness": "4", "nightmare": "0", "dissociation": "0" }, "Control group": { "dizziness": "1", "nightmare": "0", "dissociation": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-01", "end": "2024-12" }, "registration": { "number": "ChiCTR2200066303", "date": "2022-11-30" }, "note": "80 randomized (Methods planned 40 per group; per-arm randomized numbers not printed, Fig. 1 not reproduced); 5 refused to continue, 3 had the surgical approach changed and 3 were lost to follow-up, leaving 34 control and 35 esketamine analysed. Depression is HAMD-17 > 7 (Table 2, n (%)) at pre-operation, POD 1, 3 and 5; Table 3 gives the change (postoperative minus preoperative score) as median (IQR). Absolute HAMD-17 scores are only in Supplementary Table 2 (not in this text); POD 2 HAMD-17 is not reported despite being planned. Pain: VAS median (IQR) at POD 1 and POD 2 recorded; PACU admission, POD 3 and POD 5 left out (the text also mentions 6 h, which Table 4 lacks). Table 5's total postoperative opioid dose (morphine equivalents, mg, 114.9 ± 23.32 vs 100.9 ± 25.72) and PCIA button presses (9.32 ± 6.48 vs 6.54 ± 4.39) have no stated time window (PCIA ran more than 72 h), so they are not assigned to day 1 or 2. Adverse events are postoperative (Table 5): dizziness ('Diziness') yes 1 (2.9) vs 4 (11.4); nightmares and dissociation 0 in both. Enrollment period is the Methods' 'conducted ... between January 2023 and December 2024' (Results do not state it). Registration date printed '2022–11–30', registered prior to enrollment.", "decided_by": "both coders" }, { "trial": "T109", "source": "fulltext", "arms": { "Group S (esketamine)": { "randomized": "46", "analysed": "41" }, "Group C (saline)": { "randomized": "46", "analysed": "39" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "count", "definition": "HADS-D ≥ 8", "location": "Table 3", "values": { "Group S (esketamine)": { "events": "7", "n": "41" }, "Group C (saline)": { "events": "6", "n": "39" } } }, { "measure": "HADS-D", "day": 14, "form": "mean_sd", "location": "Results, Emotional Performance paragraph", "values": { "Group S (esketamine)": { "mean": "4.34", "sd": "2.17" }, "Group C (saline)": { "mean": "5.38", "sd": "2.41" } } }, { "measure": "HADS-D", "day": 14, "form": "count", "definition": "HADS-D ≥ 8 at any postoperative time point (POD1 to POD14)", "location": "Table 3", "values": { "Group S (esketamine)": { "events": "8", "n": "41" }, "Group C (saline)": { "events": "15", "n": "39" } } } ], "pain": [ { "measure": "NRS at rest (AUC over 48 h)", "day": 1, "form": "median_iqr", "location": "Table 5", "values": { "Group S (esketamine)": { "median": "2", "q1": "2", "q3": "4", "n": "41" }, "Group C (saline)": { "median": "3", "q1": "2", "q3": "5", "n": "39" } } }, { "measure": "NRS at rest (AUC over 48 h)", "day": 2, "form": "median_iqr", "location": "Table 5", "values": { "Group S (esketamine)": { "median": "1", "q1": "0", "q3": "2", "n": "41" }, "Group C (saline)": { "median": "2", "q1": "1", "q3": "3", "n": "39" } } }, { "measure": "Sufentanil consumption (first 24h)", "day": 1, "form": "median_iqr", "location": "Table 2", "values": { "Group S (esketamine)": { "median": "18", "q1": "12", "q3": "25", "n": "41" }, "Group C (saline)": { "median": "24", "q1": "18", "q3": "32", "n": "39" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "Group S (esketamine)": { "dizziness": "6", "nightmare": "0", "hallucination": "0" }, "Group C (saline)": { "dizziness": "2", "nightmare": "0", "hallucination": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-11-04", "end": "2024-12-07" }, "registration": { "number": "NCT06073015", "date": "2023-10-27" }, "note": "Analysed n: Tables 1 to 3 and 5 and the Results text give esketamine 41 and control 39 (the Results' dropout list fits this); Figure 1's description reverses them ('41 participants analyzed in the Control Group and 39 in the Esketamine Group') and lists different exclusions; took the tables. HADS-D at the other times is in Supplementary Table 1 (not available); Figure 2B's description lists HADS-D values by time (esketamine 5.2, 4.4, 4.2, 4.4, 4.4; control 5.1, 5.5, 5.2, 5.4, 5.4 for pre, POD1, POD3, POD7, POD14) without SDs, which look read off the plot (POD14 esketamine 4.4 vs 4.34 in the text), so not recorded. POD14 means are from the per-protocol set (N = 80); ITT results (Supplementary Table 2) not available. Table 3's postoperative depression count is HADS-D ≥ 8 at any postoperative time point through POD14, coded as day 14; its preoperative count is coded day -1 (HADS taken the day before surgery). NRS: Table 5 prints the NRS rows under 'DizzinessNRS' (24 h 2(2–4) vs 3(2–5); 48 h 1(0–2) vs 2(1–3); P 0.056 and 0.194), while the Results text gives different values (24 h 2 [2–4] vs 2 [2–5]; 48 h 0 [0–2] vs 1 [1–3], P = 0.023) and Figure 3A's description others again; took the table. These are point NRS-at-rest scores at 24 and 48 h, recorded under the design's AUC measure name; the AUC itself is not printed (Figure 3B bar heights only). Sufentanil consumption (first 24h) is not in the design and is named as the source does (units not stated); PCA presses in the first 24 h (demand 10 (6–15) vs 14 (9–20); delivered 8 (5–12) vs 11 (7–16)) not recorded. Dizziness from Table 5 (text: 14.6% vs 5.1%); nightmare and hallucination zeros from 'no cases of nightmares, respiratory depression, seizures, or hallucinations were reported in either group'.", "decided_by": "both coders" }, { "trial": "T111", "source": "fulltext", "arms": { "Group E (esketamine)": { "randomized": "48", "analysed": "46" }, "Group C (saline)": { "randomized": "48", "analysed": "45" } }, "depression": [], "pain": [ { "measure": "VAS pain", "day": 1, "form": "median_iqr", "location": "Table 2 (VAS scores, 24 h)", "values": { "Group E (esketamine)": { "median": "2", "q1": "1", "q3": "2", "n": "46" }, "Group C (saline)": { "median": "2", "q1": "2", "q3": "2", "n": "45" } } }, { "measure": "VAS pain", "day": 2, "form": "median_iqr", "location": "Table 2 (VAS scores, 48 h)", "values": { "Group E (esketamine)": { "median": "1.5", "q1": "1", "q3": "2", "n": "46" }, "Group C (saline)": { "median": "2", "q1": "1", "q3": "2", "n": "45" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 4 (Postoperative Adverse Reactions, within 48 h)", "values": { "Group E (esketamine)": { "nightmare": "0", "psychiatric_any": "1", "dizziness": "1" }, "Group C (saline)": { "nightmare": "0", "psychiatric_any": "0", "dizziness": "2" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT06920576", "date": null }, "note": "Three-arm trial; Group M (magnesium sulfate, role 'other') is not extracted. 48 randomized per group (Methods: '48 patients per group were enrolled'; CONSORT: each group 'with 48 patients receiving allocated interventions'). Analysed: Group C 45 (1 dropout for intractable hypertension, 2 declined callbacks), Group E 46 (2 dropouts for intractable hypertension); per-protocol, missing data 7/144. Depression: HADS-D and Zung SDS (PRE, POD1, POD2) appear only in Figures 2 (box plots) and 3 (bar graphs), whose descriptions give readings estimated from the charts ('~7' vs '~6', 'about 54' vs 'about 49'), not printed values, so nothing is entered; the text says Group E had lower HADS-D and SDS than Group C on POD1 (P < 0.01) and POD2 (P < 0.001). Pain: Table 2 VAS at 24 h is day 1 and at 48 h day 2, median (IQR) printed as 'median (q1, q3)'; 2, 4 and 8 h are day 0 and left out. Rescue ketorolac (Table 3: 2 (4.3%) Group E vs 9 (20%) Group C) was given in the PACU for VAS > 3, with no day 1 or day 2 time, so it is left out. Adverse events (Table 4, within 48 h postoperatively): the combined row 'Hallucinations or double vision' (Group E 1, Group C 0) is entered as psychiatric_any, since no separate hallucination or diplopia count is printed, so neither hallucination nor visual is entered. 'Dizziness or headache' (1 vs 2) is entered as dizziness although it includes headache. Nightmares are printed as 0 (0%) in both arms. Also reported (E vs C): PONV 1 vs 6, respiratory depression 0 vs 5, hypersomnia 1 vs 1, dry mouth 1 vs 0, flushing 0 vs 0, sweating 0 vs 0. No enrollment dates are given. Registered at ClinicalTrials.gov (NCT06920576) 'before patient enrollment', with no date.", "decided_by": "third reader" }, { "trial": "T112", "source": "fulltext", "arms": { "Esketamine": { "randomized": "218", "analysed": "207" }, "Placebo (normal saline)": { "randomized": "217", "analysed": "203" } }, "depression": [ { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative assessment, MADRS, median (IQR))", "values": { "Esketamine": { "median": "24", "q1": "23", "q3": "27", "n": "218" }, "Placebo (normal saline)": { "median": "24", "q1": "22", "q3": "27", "n": "217" } } }, { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": -1, "form": "count", "definition": "severe depressive symptoms, MADRS ≥ 30", "location": "Table 1 (Severe depressive symptoms, n (%)); Results 3.1 (22/218, 22/217)", "values": { "Esketamine": { "events": "22", "n": "218", "definition": "severe depressive symptoms, MADRS ≥ 30" }, "Placebo (normal saline)": { "events": "22", "n": "217", "definition": "severe depressive symptoms, MADRS ≥ 30" } } }, { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": 3, "form": "median_iqr", "location": "Table 2, Assessments on POD3 (MADRS score, median (IQR))", "values": { "Esketamine": { "median": "15", "q1": "10", "q3": "20", "n": "207" }, "Placebo (normal saline)": { "median": "18", "q1": "15", "q3": "22", "n": "203" } } }, { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": 3, "form": "count", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)", "location": "Table 2, Primary Outcome (Remission on day 3, No./total (%))", "values": { "Esketamine": { "events": "59", "n": "207", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)" }, "Placebo (normal saline)": { "events": "23", "n": "203", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)" } }, "counts": "improvement" }, { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": 3, "form": "count", "definition": "response, MADRS reduction ≥ half of baseline (events are responders, not participants with depression)", "location": "Table 2, Assessments on POD3 (Response, No./total (%))", "values": { "Esketamine": { "events": "89", "n": "207", "definition": "response, MADRS reduction ≥ half of baseline (events are responders, not participants with depression)" }, "Placebo (normal saline)": { "events": "35", "n": "203", "definition": "response, MADRS reduction ≥ half of baseline (events are responders, not participants with depression)" } }, "counts": "improvement" }, { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": 5, "form": "median_iqr", "location": "Table 2, Assessments on discharge (MADRS score, median (IQR))", "values": { "Esketamine": { "median": "14", "q1": "10", "q3": "19", "n": "198" }, "Placebo (normal saline)": { "median": "17", "q1": "13", "q3": "21", "n": "201" } } }, { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": 5, "form": "count", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)", "location": "Table 2, Assessments on discharge (Remission, No./total (%))", "values": { "Esketamine": { "events": "62", "n": "198", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)" }, "Placebo (normal saline)": { "events": "30", "n": "201", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)" } }, "counts": "improvement" }, { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "day": 5, "form": "count", "definition": "response, MADRS reduction ≥ half of baseline (events are responders, not participants with depression)", "location": "Table 2, Assessments on discharge (Response, No./total (%))", "values": { "Esketamine": { "events": "86", "n": "198", "definition": "response, MADRS reduction ≥ half of baseline (events are responders, not participants with depression)" }, "Placebo (normal saline)": { "events": "47", "n": "201", "definition": "response, MADRS reduction ≥ half of baseline (events are responders, not participants with depression)" } }, "counts": "improvement" } ], "pain": [ { "measure": "Moderate-to-severe pain (any NRS >=4 within 72 h)", "day": 2, "form": "count", "definition": "NRS pain score > 3, 0–48 h", "location": "Table 2, Secondary Outcomes (NRS pain score > 3, 0–48 h, n (%))", "values": { "Esketamine": { "events": "50", "n": "218", "definition": "NRS pain score > 3, 0–48 h" }, "Placebo (normal saline)": { "events": "47", "n": "217", "definition": "NRS pain score > 3, 0–48 h" } } } ], "adverse_events": [ { "window": "postoperative", "time": "first 72 h after surgery (assessed at 4 h, 1 day, and 3 days after anesthesia)", "location": "Table 2, Adverse events (Dissociative symptoms, CADSS score ≥ 5); Results 3.4", "n": { "Esketamine": "218", "Placebo (normal saline)": "217" }, "terms": { "dissociation": "Dissociative symptoms (CADSS score≥5)" }, "values": { "Esketamine": { "dissociation": "19" }, "Placebo (normal saline)": { "dissociation": "4" } } } ], "blinding_check": null, "enrollment": { "start": "2021-02", "end": "2024-06" }, "registration": { "number": "NCT04425473", "date": "2020-06-11" }, "note": "Randomized 218 and 217; 25 were lost to follow-up (aphasia or other conditions), so 'analysed' is the day-3 denominators, 207 and 203; discharge assessments have 198 and 201, and Table 2's header (218, 217) is the n for the pain and adverse-event rows. 'Assessments on discharge' are coded day 5: Methods plan MADRS at 3 and 5 days and bedside follow-up 'on days 1, 2, 3, and 5 or at discharge', but median hospital stay was 11 (9−14) vs 12 (9−15) days, so the timing is uncertain. MADRS score n at POD3 and at discharge are the MADRS remission and response denominators in the same section. Remission (MADRS ≤ 10) and response (MADRS reduction ≥ half of baseline) counts are participants who improved, not participants with depression; their definitions say so. The baseline count is Table 1's 'Severe depressive symptoms' (MADRS ≥ 30, Methods 2.4 and Fig. 3). The text gives day-3 remission as 28.3% (59/207); Table 2 prints 59/207 (28.5); the table's is taken. The text's day-3 MADRS IQR is garbled ('15 [10], [11], ... [20]'); the table's 15 (10–20) is taken. Pain: the design's measure (any NRS ≥ 4 within 72 h) is printed as 'NRS pain score > 3, 0–48 h' and coded day 2. Not extracted because the design doesn't list them (esketamine vs placebo): PHQ-9 at baseline 12 (11–14) vs 12 (10–13), PHQ-9 ≥ 10 52/207 vs 81/203 on POD3 and 44/198 vs 57/201 at discharge; HADS (defined as HADS-Depression, though baseline values above 21 suggest the total scale) 22 (18–25) vs 21 (17–24) at baseline, 16 (11–21) vs 20 (16–22) on POD3, and 17 (11–21) vs 19 (15–22) at discharge; GAD-7; and rescue analgesia, 0–48 h, 58 (26.6) vs 59 (27.2). Adverse events are Table 2's, assessed during the first 72 h: dissociative symptoms (CADSS ≥ 5) as dissociation. Not mapped to a category: psychotic side effects (4-item BPRS ≥ 5: unusual thought content, suspiciousness, hallucinations, conceptual disorganization) 23 vs 25, manic symptoms (YMRS ≥ 5) 14 vs 11, delirium 4 vs 11, and PONV 0–48 h 46 vs 50. Enrollment is the Methods' screening window (major surgery 'between February 19, 2021, and June 20, 2024'). The trial stopped at a prespecified interim analysis (435 of 564 planned).", "decided_by": "third reader" }, { "trial": "T113", "source": "fulltext", "arms": { "ES1 group": { "randomized": "33", "analysed": "31" }, "ES2 group": { "randomized": "33", "analysed": "30" }, "C group": { "randomized": "33", "analysed": "30" } }, "depression": [ { "measure": "HAMD", "day": -1, "form": "mean_sd", "location": "Table 4 (Preop)", "values": { "ES1 group": { "mean": "8.0", "sd": "2.1" }, "ES2 group": { "mean": "8.0", "sd": "2.7" }, "C group": { "mean": "6.8", "sd": "2.7" } } }, { "measure": "HAMD", "day": 1, "form": "mean_sd", "location": "Table 4 (24 h postop)", "values": { "ES1 group": { "mean": "6.2", "sd": "2.2" }, "ES2 group": { "mean": "7.1", "sd": "2.6" }, "C group": { "mean": "9.9", "sd": "3.7" } } }, { "measure": "HAMD", "day": 3, "form": "mean_sd", "location": "Table 4 (72 h postop)", "values": { "ES1 group": { "mean": "5.2", "sd": "2.4" }, "ES2 group": { "mean": "5.6", "sd": "2.6" }, "C group": { "mean": "9.0", "sd": "3.5" } } } ], "pain": [ { "measure": "VAS at rest (24 h)", "day": 1, "form": "mean_sd", "location": "Table 5 (24 h postop)", "values": { "ES1 group": { "mean": "0.71", "sd": "0.82" }, "ES2 group": { "mean": "0.97", "sd": "1.00" }, "C group": { "mean": "0.62", "sd": "0.82" } } }, { "measure": "VAS on activity (24 h)", "day": 1, "form": "mean_sd", "location": "Table 6 (24 h postop)", "values": { "ES1 group": { "mean": "2.87", "sd": "1.34" }, "ES2 group": { "mean": "3.17", "sd": "1.39" }, "C group": { "mean": "2.93", "sd": "1.00" } } } ], "adverse_events": [ { "window": "postoperative", "time": "24 h", "location": "Table 7 (24 h AE, n (%))", "values": { "ES1 group": { "any_ae": "7" }, "ES2 group": { "any_ae": "5" }, "C group": { "any_ae": "8" } } }, { "window": "postoperative", "time": "48 h", "location": "Table 7 (48 h AE, n (%))", "values": { "ES1 group": { "any_ae": "1" }, "ES2 group": { "any_ae": "3" }, "C group": { "any_ae": "6" } } } ], "blinding_check": null, "enrollment": { "start": "2023-05-01", "end": "2024-01-01" }, "registration": { "number": "ChiCTR2300070763", "date": null }, "note": "99 randomized, 33 per group (Table 1). 8 were excluded before receiving the intervention (5 withdrew consent or family refused assessment at the preoperative evaluation, 3 intraoperative conversions); analysed per Table 3's headers: C 30, ES1 31, ES2 30. Tables 4-7 and the text print no n at any time point, so no n is entered in the outcome values; the arms' analysed counts apply. HAMD is HAMD-17 (Fig. 1), mean ± SD (Statistical analysis: 'Continuous data: Mean ± SD'), from Table 4: 'Preop' (administered 24 h before surgery) is day -1, '24 h postop' day 1, '72 h postop' day 3; the Results text repeats group C's values (6.8 ± 2.7, 9.9 ± 3.7, 9.0 ± 3.5), matching the table. The primary outcome (Table 2) is HAMA/HAMD score ≥ 8 at 24 h, but no counts by arm are printed. Pain: VAS at rest (Table 5) and on activity (Table 6) at 24 h are day 1, with the within-group superscript letters dropped; 2 h, 6 h and 72 h are outside the windows. 'PCA bolus demands' (Results: C 4.69 ± 4.38, ES1 4.16 ± 2.60, ES2 5.77 ± 6.59; Table 2 lists supplemental analgesia demands for 0-24 h postop) is not a pain measure the design lists, so it is not entered; the ES groups' PCA itself held esketamine (1 or 2 mg/kg), with sufentanil 2 µg/kg in all groups. Adverse events: Table 7 gives only the number with any adverse event at 24 h and at 48 h (one entry each; the two counts may include the same patients); Table 2 lists PONV, dizziness and nightmares (0-72 h) and nystagmus, pruritus and hallucinations as safety outcomes, but no counts by type are printed. Enrollment: the Results give no dates; the Methods' inclusion criteria name surgery between May 1, 2023 and January 1, 2024. Registration ChiCTR2300070763, no date given.", "decided_by": "third reader" }, { "trial": "T114", "source": "fulltext", "arms": { "ES group": { "randomized": null, "analysed": "26" }, "Control group": { "randomized": null, "analysed": "27" } }, "depression": [ { "measure": "Zung SDS", "day": -1, "form": "mean_sd", "location": "Table 2 (T0, PreOP)", "values": { "ES group": { "mean": "53.76", "sd": "4.83", "n": "26" }, "Control group": { "mean": "53.25", "sd": "3.72", "n": "27" } } }, { "measure": "Zung SDS", "day": 1, "form": "mean_sd", "location": "Table 2 (T1, POD 1)", "values": { "ES group": { "mean": "47.69", "sd": "2.98", "n": "26" }, "Control group": { "mean": "53.85", "sd": "3.37", "n": "27" } } }, { "measure": "Zung SDS", "day": 3, "form": "mean_sd", "location": "Table 2 (T2, POD 3)", "values": { "ES group": { "mean": "45.61", "sd": "2.55", "n": "26" }, "Control group": { "mean": "54.44", "sd": "3.02", "n": "27" } } }, { "measure": "Zung SDS", "day": 7, "form": "mean_sd", "location": "Table 2 (T3, POD 7)", "values": { "ES group": { "mean": "43.07", "sd": "2.30", "n": "26" }, "Control group": { "mean": "52.70", "sd": "2.77", "n": "27" } } } ], "pain": [ { "measure": "VAS pain", "day": 1, "form": "mean_sd", "location": "Table 7 (VAS score; POD 1 per Methods)", "values": { "ES group": { "mean": "1.46", "sd": "0.82", "n": "26" }, "Control group": { "mean": "2.43", "sd": "1.07", "n": "27" } } } ], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2024-11", "end": "2025-08" }, "registration": { "number": "ChiCTR2500098063", "date": null }, "note": "The source calls the control arm 'C group'. Randomized per arm is not printed: 58 were randomized (the sample-size target was 58, 29 per group), 5 were lost to follow-up before POD 7 (arms not given), and the per-protocol efficacy analysis has C 27 and ES 26 (Tables 1, 2, 7); all 58 were in the safety analysis. Baseline SDS differs between tables: Table 1 gives C 53.23 ± 3.66 and ES 53.53 ± 4.71, Table 2 (the SDS outcome table, used here) C 53.25 ± 3.72 and ES 53.76 ± 4.83. The dichotomy SDS ≥ 53 is defined in Methods but no counts are reported. VAS is the single POD 1 assessment (Methods). Adverse events within 24 h after surgery (Table 7: headache C 3, ES 2; nausea/vomiting C 8, ES 10; drowsiness C 2, ES 1) include none of the codebook's categories. Enrollment dates are from Methods (November 2024 to August 2025); the Results don't restate them. Described as prospectively registered; no registration date given.", "decided_by": "both coders" }, { "trial": "T116", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "68", "analysed": "68" }, "Normal saline group": { "randomized": "68", "analysed": "68" } }, "depression": [ { "measure": "EPDS", "day": 2, "form": "mean_sd", "location": "Table 2, Total scores", "values": { "Esketamine group": { "mean": "21.10", "sd": "2.02", "n": "68" }, "Normal saline group": { "mean": "23.34", "sd": "2.01", "n": "68" } } }, { "measure": "EPDS", "day": 3, "form": "count", "definition": "PPD as the paper reports it; criterion not stated (EPDS is the only depression scale the paper names)", "location": "Results, 'Comparison of postpartum depression (PPD) incidence' (text)", "values": { "Esketamine group": { "events": "4", "n": null }, "Normal saline group": { "events": "15", "n": null } } }, { "measure": "EPDS", "day": 7, "form": "mean_sd", "location": "Table 3, Total scores", "values": { "Esketamine group": { "mean": "17.86", "sd": "2.17", "n": "68" }, "Normal saline group": { "mean": "20.55", "sd": "2.21", "n": "68" } } } ], "pain": [], "adverse_events": [ { "window": "intraoperative", "location": "Table 6 (rows without 'Postoperative'; text: intraoperative adverse reactions)", "values": { "Esketamine group": { "dizziness": "14", "hallucination": "1", "dissociation": "1", "agitation": "1", "visual": "2" }, "Normal saline group": { "dizziness": "11", "hallucination": "2", "dissociation": "3", "agitation": "1", "visual": "1" } } }, { "window": "postoperative", "location": "Table 6 ('Postoperative dizziness')", "values": { "Esketamine group": { "dizziness": "3" }, "Normal saline group": { "dizziness": "4" } } } ], "blinding_check": null, "enrollment": { "start": "2024-08", "end": "2025-08" }, "registration": { "number": "ChiCTR2400088992", "date": null }, "note": "Single-blind (mothers only). The paper calls the Esketamine group 'study group' and the Normal saline group 'control group'; Tables 2 to 5 list the control group first. EPDS entries are the 'Total scores' rows, copied as printed (about 18 to 23, high beside the PPD rates). PPD incidence is given only in the text, with no criterion stated: day 3, 4 (5.88%) vs 15 (22.06%), no denominator printed (the percentages fit 68 per arm), entered under EPDS as a count without n; days 7 and 14 as percentages only (5.08% vs 22.41%; 5.08% vs 20.69%), which are not k/68, so fewer were assessed then; day 30 not significant, no numbers; Figure 2 has no printed values; none of these entered. Pain: VAS at rest and during movement (4, 12, 24 h) appear only in Figure 4, with no printed values, so nothing is entered. Table 4's PCIA pump presses are not a design measure and are not entered: within 24 h 2.57±0.74 vs 4.15±1.22, within 48 h 3.55±1.24 vs 4.75±1.33, time to first press 5.63±0.81 vs 5.79±0.72 h (esketamine vs saline). Adverse events (Table 6): rows without 'Postoperative' are intraoperative, as the text says; 'Illusion' coded as hallucination (the text calls them hallucinations), 'Restless and agitated' as agitation, 'Nystagmus' as visual; 'Disgusting' (nausea), vomiting, hypertension, tremble, hypertonia and cold sweat not coded; postoperative events were monitored for 24 h. Enrollment period is the trial period in Methods ('between August 2024 and August 2025'); the Results give none.", "decided_by": "third reader" }, { "trial": "T117", "source": "fulltext", "arms": { "Experimental group (esketamine)": { "randomized": "66", "analysed": "65" }, "Placebo group": { "randomized": "65", "analysed": "65" } }, "depression": [ { "measure": "MADRS", "day": -1, "form": "median_iqr", "location": "Table 1 (MADRS score, median (IQR))", "values": { "Experimental group (esketamine)": { "median": "25", "q1": "24", "q3": "27", "n": "65" }, "Placebo group": { "median": "24", "q1": "24", "q3": "28", "n": "65" } } }, { "measure": "MADRS", "day": 1, "form": "count", "definition": "response, ≥ 50% decrease in MADRS from baseline (events are responders, not participants with depression)", "location": "Table 2 (MADRS Response rate, POD 1)", "values": { "Experimental group (esketamine)": { "events": "35", "n": "65" }, "Placebo group": { "events": "17", "n": "65" } }, "counts": "improvement" }, { "measure": "MADRS", "day": 1, "form": "count", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)", "location": "Table 2 (MADRS Remission rate, POD 1)", "values": { "Experimental group (esketamine)": { "events": "22", "n": "65" }, "Placebo group": { "events": "7", "n": "65" } }, "counts": "improvement" }, { "measure": "MADRS", "day": 1, "form": "difference", "location": "Results 3.1, paragraph after Table 2 (aMD from mixed-effects model; Figure 2 has no printed values)", "estimate": "-1.97", "lower": "-3.505", "upper": "-0.433", "level": "0.95", "scale": "mean_difference", "values": { "Experimental group (esketamine)": { "n": "65" }, "Placebo group": { "n": "65" } }, "contrast_sign": "ketamine_minus_control" }, { "measure": "MADRS", "day": 2, "form": "count", "definition": "response, ≥ 50% decrease in MADRS from baseline (events are responders, not participants with depression)", "location": "Table 2 (MADRS Response rate, POD 2)", "values": { "Experimental group (esketamine)": { "events": "39", "n": "65" }, "Placebo group": { "events": "26", "n": "65" } }, "counts": "improvement" }, { "measure": "MADRS", "day": 2, "form": "count", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)", "location": "Table 2 (MADRS Remission rate, POD 2)", "values": { "Experimental group (esketamine)": { "events": "26", "n": "65" }, "Placebo group": { "events": "15", "n": "65" } }, "counts": "improvement" }, { "measure": "MADRS", "day": 2, "form": "difference", "location": "Results 3.1, paragraph after Table 2 (aMD from mixed-effects model; Figure 2 has no printed values)", "estimate": "-1.68", "lower": "-3.213", "upper": "-0.141", "level": "0.95", "scale": "mean_difference", "values": { "Experimental group (esketamine)": { "n": "65" }, "Placebo group": { "n": "65" } }, "contrast_sign": "ketamine_minus_control" }, { "measure": "MADRS", "day": 3, "form": "count", "definition": "response, ≥ 50% decrease in MADRS from baseline (events are responders, not participants with depression)", "location": "Table 2 (MADRS Response rate, POD 3)", "values": { "Experimental group (esketamine)": { "events": "48", "n": "65" }, "Placebo group": { "events": "35", "n": "65" } }, "counts": "improvement" }, { "measure": "MADRS", "day": 3, "form": "count", "definition": "remission, MADRS ≤ 10 (events are participants in remission, not with depression)", "location": "Table 2 (MADRS Remission rate, POD 3)", "values": { "Experimental group (esketamine)": { "events": "37", "n": "65" }, "Placebo group": { "events": "15", "n": "65" } }, "counts": "improvement" }, { "measure": "MADRS", "day": 3, "form": "difference", "location": "Results 3.1, paragraph after Table 2 (aMD from mixed-effects model; Figure 2 has no printed values)", "estimate": "-2.046", "lower": "-3.582", "upper": "-0.510", "level": "0.95", "scale": "mean_difference", "values": { "Experimental group (esketamine)": { "n": "65" }, "Placebo group": { "n": "65" } }, "contrast_sign": "ketamine_minus_control" }, { "measure": "PHQ-9", "day": -1, "form": "median_iqr", "location": "Table 1 (PHQ-9 score, median (IQR))", "values": { "Experimental group (esketamine)": { "median": "16", "q1": "14", "q3": "17", "n": "65" }, "Placebo group": { "median": "16", "q1": "14", "q3": "18", "n": "65" } } }, { "measure": "PHQ-9", "day": 3, "form": "median_iqr", "location": "Table 2 (PHQ-9 score on POD 3, median (IQR))", "values": { "Experimental group (esketamine)": { "median": "6", "q1": "5", "q3": "8", "n": "65" }, "Placebo group": { "median": "8", "q1": "6", "q3": "12", "n": "65" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 3 (POD 1: dizziness); Table 2 (POD 1: CADSS score > 0)", "values": { "Experimental group (esketamine)": { "dizziness": "7", "dissociation": "1" }, "Placebo group": { "dizziness": "7", "dissociation": "2" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR2300078540", "date": null }, "note": "Randomized 66 esketamine / 65 placebo; one esketamine patient was excluded (data lost after discharge on POD 1), so 65/65 analysed. Postoperative MADRS scores are given only as adjusted mean differences (aMD, mixed-effects model with random intercepts; negative favours esketamine) in Results 3.1; Figure 2 prints no values. Minus signs printed as U+2010 hyphens are written '-'. Response and remission counts are participants who improved, not participants with depression; their definitions say so. Postoperative NRS pain (2 h, 4 h, POD 1-3) is only in Supplementary Table S6, not in the source, so pain is empty (Table 1 has preoperative NRS > 3 counts only). Adverse events: one postoperative entry from the first postoperative assessment (POD 1), the one nearest the intraoperative infusion; dizziness 7 vs 7 is also the POD 1-3 total, since the text says no further dizziness occurred on POD 2 or POD 3. Later assessments (esketamine vs placebo), not summable because a participant can count on several days: CADSS > 0 (dissociation) POD 2 1 vs 1, POD 3 3 vs 1, 2 weeks 0 vs 0, 1 month 0 vs 0; dizziness POD 2 0 vs 0, POD 3 0 vs 0. Not mapped: BPRS > 30 (a broad psychopathology threshold, not a combined count of psychiatric events; the source reports dissociation and mania separately, so psychiatric_any does not apply) POD 1 3 vs 4, POD 2 1 vs 4, POD 3 1 vs 4, 2 weeks 1 vs 1, 1 month 0 vs 3; YMRS >= 5 (subclinical hypomania) POD 1 4 vs 3, POD 2 3 vs 1, POD 3 3 vs 1, 2 weeks 3 vs 0, 1 month 2 vs 0; nausea and vomiting (Table 3). Baseline (Table 1): CADSS not 0 4 vs 4, BPRS > 30 0 vs 3, YMRS >= 5 13 vs 21. HADS-A not extracted. No enrollment dates given.", "decided_by": "third reader" }, { "trial": "T118", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "42", "analysed": "18" }, "Saline placebo group": { "randomized": "41", "analysed": "17" } }, "depression": [ { "measure": "MADRS", "day": -1, "form": "mean_sd", "location": "Table 1", "values": { "Esketamine group": { "mean": "19.39", "sd": "3.38", "n": "18" }, "Saline placebo group": { "mean": "19.06", "sd": "3.82", "n": "17" } } }, { "measure": "PHQ-9", "day": -1, "form": "mean_sd", "location": "Table 1", "values": { "Esketamine group": { "mean": "10.28", "sd": "2.24", "n": "18" }, "Saline placebo group": { "mean": "9.82", "sd": "2.58", "n": "17" } } } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": null, "registration": { "number": "ChiCTR2300071062", "date": null }, "note": "Secondary neuroimaging analysis of the EASE trial: 83 of 108 eligible RCT patients consented to MRI and were randomized 42 esketamine / 41 placebo; 45 declined the follow-up MRI and 3 were excluded for head motion, leaving 18/17 analysed. MADRS was rated at baseline (day before surgery), PODs 1-5 and weeks 4 and 12, but no postoperative values are printed, only correlations of MADRS change with network measures in the esketamine group. Baseline PHQ-9 is a depression measure the design does not list. The healthy-control group (n = 35) has role 'other' and is left out. No adverse events, pain, or enrollment dates reported.", "decided_by": "both coders" }, { "trial": "T119", "source": "fulltext", "arms": { "ES group": { "randomized": "60", "analysed": "60" }, "P group (saline)": { "randomized": "60", "analysed": "60" } }, "depression": [ { "measure": "PHQ-9", "day": -1, "form": "mean_sd", "location": "Table 2 (Baseline)", "values": { "ES group": { "mean": "5.3", "sd": "3.70", "n": "60" }, "P group (saline)": { "mean": "5.2", "sd": "2.44", "n": "60" } } }, { "measure": "PHQ-9", "day": 7, "form": "change_difference", "location": "Table 4 (linear mixed model, group * Timepoint, P * POD7); Results, Secondary outcome", "estimate": "1.25", "lower": "0.45", "upper": "2.05", "level": "0.95", "scale": "mean_difference", "direction": "P group (saline) minus ES group, change from baseline", "values": { "ES group": { "n": "60" }, "P group (saline)": { "n": "60" } }, "contrast_sign": "control_minus_ketamine" }, { "measure": "PHQ-9", "day": 30, "form": "mean_sd", "location": "Table 2 (POD30-PHQ9)", "values": { "ES group": { "mean": "2.2", "sd": "1.54", "n": "60" }, "P group (saline)": { "mean": "3.1", "sd": "1.87", "n": "60" } } }, { "measure": "PHQ-9", "day": 30, "form": "change_mean_sd", "location": "Table 2 (Change from Baseline, Mean (SD))", "values": { "ES group": { "mean": "-3.1", "sd": "3.33", "n": "60" }, "P group (saline)": { "mean": "-2.1", "sd": "2.14", "n": "60" } } }, { "measure": "PHQ-9", "day": 30, "form": "change_mean_ci", "location": "Table 2 (Change from Baseline, LS Mean (95% CI), ANCOVA adjusted for baseline)", "values": { "ES group": { "mean": "-3.07", "lower": "-3.46", "upper": "-2.68", "level": "0.95", "n": "60" }, "P group (saline)": { "mean": "-2.11", "lower": "-2.50", "upper": "-1.72", "level": "0.95", "n": "60" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Table 5 (Total NRS scores on POD1)", "values": { "ES group": { "median": "3", "q1": "2", "q3": "3", "n": "60" }, "P group (saline)": { "median": "3", "q1": "2.8", "q3": "3", "n": "60" } } } ], "adverse_events": [ { "window": "postoperative", "values": { "ES group": { "psychiatric_any": "1" }, "P group (saline)": { "psychiatric_any": "0" } } } ], "blinding_check": null, "enrollment": null, "registration": null, "note": "All 120 randomized (60 per arm) received the allocated intervention and completed follow-up, with no missing data, and were analysed by intention to treat (Results). PHQ-9 on POD7 has no arm summaries: only the linear mixed model's group-by-timepoint coefficient P * POD7 (Table 4: 1.25, 95% CI 0.45 to 2.05; ES is the reference, so it is P minus ES in change from baseline to POD7, positive favouring ES), coded as change_difference with each arm's n of 60 (Table 4 prints N 60 for P * POD7 and 120 for POD7). At POD30 Table 2 gives raw means, raw change from baseline, and the ANCOVA (baseline-adjusted) LS mean change with its 95% CI, the pre-specified primary analysis; each is coded in its own form. The between-arm results at POD30 are not coded because arm values exist: Table 2's difference in LS mean P - ES 0.96 (0.42, 1.51), Table 4's P * POD30 1.05 (0.25, 1.85), and Table 8's overall subgroup-model MD -1.13 (-1.74, -0.53) and SMD -0.81 (-1.18, -0.44). NRS at rest on POD1 from Table 5 (columns P before ES); baseline NRS 0[0,0] in both arms. Adverse events from Table 6 (within 24 h after surgery): 'Psychiatric symptoms' P 0, ES 1 (1.7%), coded psychiatric_any; nausea and vomiting and drowsiness are not listed categories. No enrollment dates or registration number in the text.", "decided_by": "third reader" }, { "trial": "T120", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "168", "analysed": "164" }, "Control group": { "randomized": "168", "analysed": "158" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Esketamine group": { "median": "6", "q1": "4", "q3": "7", "n": "164" }, "Control group": { "median": "5", "q1": "3", "q3": "8", "n": "158" } } }, { "measure": "EPDS", "day": 7, "form": "count", "location": "Table 2", "definition": "EPDS ≥ 10 (PPD)", "values": { "Esketamine group": { "events": "8", "n": "164" }, "Control group": { "events": "24", "n": "158" } } }, { "measure": "EPDS", "day": 7, "form": "median_iqr", "location": "Table 2 (n from the PPD row's denominators at the same time)", "values": { "Esketamine group": { "median": "4", "q1": "2", "q3": "6", "n": "164" }, "Control group": { "median": "5", "q1": "2", "q3": "8", "n": "158" } } }, { "measure": "EPDS", "day": 30, "form": "count", "location": "Table 2", "definition": "EPDS ≥ 10 (PPD)", "values": { "Esketamine group": { "events": "13", "n": "158" }, "Control group": { "events": "16", "n": "149" } } }, { "measure": "EPDS", "day": 30, "form": "median_iqr", "location": "Table 2 (n from the PPD row's denominators at the same time)", "values": { "Esketamine group": { "median": "4", "q1": "2", "q3": "7", "n": "158" }, "Control group": { "median": null, "q1": "2", "q3": "7", "n": "149" } } }, { "measure": "EPDS", "day": 60, "form": "count", "location": "Table 2", "definition": "EPDS ≥ 10 (PPD)", "values": { "Esketamine group": { "events": "8", "n": "149" }, "Control group": { "events": "13", "n": "145" } } }, { "measure": "EPDS", "day": 60, "form": "median_iqr", "location": "Table 2 (n from the PPD row's denominators at the same time)", "values": { "Esketamine group": { "median": "4", "q1": "2", "q3": "7", "n": "149" }, "Control group": { "median": "4", "q1": "2", "q3": "7", "n": "145" } } }, { "measure": "EPDS", "day": 90, "form": "count", "location": "Table 2", "definition": "EPDS ≥ 10 (PPD)", "values": { "Esketamine group": { "events": "7", "n": "146" }, "Control group": { "events": "10", "n": "143" } } }, { "measure": "EPDS", "day": 90, "form": "median_iqr", "location": "Table 2 (n from the PPD row's denominators at the same time)", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "5", "n": "146" }, "Control group": { "median": "4", "q1": "2", "q3": "7", "n": "143" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "median_iqr", "location": "Results, text (24 h; Fig. 3a)", "values": { "Esketamine group": { "median": "2", "q1": "1", "q3": "4", "n": null }, "Control group": { "median": "2", "q1": "1", "q3": "5", "n": null } } }, { "measure": "effective PCIA presses", "day": 1, "form": "median_iqr", "location": "Results, text (cumulative over the 24 h PCIA; Fig. 3b)", "values": { "Esketamine group": { "median": "6", "q1": "3", "q3": "10", "n": null }, "Control group": { "median": "7", "q1": "3.5", "q3": "11", "n": null } } }, { "measure": "sufentanil consumption", "day": 1, "form": "median_iqr", "location": "Results, text (cumulative 24 h, μg, medians only; Fig. 3c)", "values": { "Esketamine group": { "median": "60", "q1": null, "q3": null, "n": null }, "Control group": { "median": "62", "q1": null, "q3": null, "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "time": "within 1 h after drug administration (during caesarean section)", "location": "Table 3", "values": { "Esketamine group": { "dizziness": "18", "hallucination": "17", "visual": "3", "dissociation": "9" }, "Control group": { "dizziness": "0", "hallucination": "0", "visual": "0", "dissociation": "0" } } }, { "window": "postoperative", "time": "24 h postpartum", "location": "Table 3; hallucination and dissociation from the Results text", "values": { "Esketamine group": { "dizziness": "21", "visual": "1", "hallucination": "0", "dissociation": "0" }, "Control group": { "dizziness": "9", "visual": "0", "hallucination": "0", "dissociation": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2021-05-01", "end": "2024-03-31", "location": "Methods (trial conducted from 1 May 2021 to 31 March 2024, which includes the 3-month follow-up); the Results give no dates" }, "registration": { "number": "NCT04860661", "date": "2021-04-20" }, "note": "Esketamine 0.25 mg/kg 15 min after cord clamping plus 80 mg in the 24 h PCIA; control saline. 336 randomized, 168 per group; modified ITT 164 (esketamine: 1 converted to general anaesthesia, 3 lost) and 158 (control: 4 converted, 6 lost). Days: 7 days, 1, 2 and 3 months = 7, 30, 60, 90; baseline EPDS taken the day before surgery (Table 1). PPD = EPDS score of at least 10 (Table 2, n/total per time). Table 2's EPDS-score rows print no n of their own; their n is the denominator printed in the PPD row at the same time (the number screened then, under the 'n/total' column heading). The control median at 1 month is missing in print (the cell reads '[2 to 7]'), so it is null; Table 2's Hodges-Lehmann median difference there is 0 (−1 to 0), not entered because arm values are given. Also not entered: total PPD within 3 months as percentages only (11.59% vs 20.89%; adjusted RR 0.57, 95% CI 0.35 to 0.94). Pain: the 24 h NRS is used for day 1 (the 18 h value, 2 [1 to 4] vs 2 [1 to 4], is not recorded since the 24 h value is printed); PCIA presses are over the 24 h PCIA; sufentanil is printed as medians only (60 vs 62 μg, cumulative 24 h per Fig. 3c). Adverse events, Table 3: events within 1 h after drug administration occurred during the caesarean ('vanished before the end of surgery'), so intraoperative; nystagmus (intraoperative) and diplopia (24 h) recorded as visual. Hallucinations were euphoric 12, unpleasant 3, neutral 2 (unpleasant ones not counted as nightmares). Postoperative hallucination and dissociation zeros come from 'No patients experienced hallucination or dissociation after surgery.' Dizziness at 24 h by grade: I 19 vs 9, II 1 vs 0, III 1 vs 0. Nausea or vomiting is not a codebook category. Trial conducted 1 May 2021 to 31 March 2024 (Methods; includes follow-up); the Results give no dates. Registration date printed '20 April 2021'. No blinding check reported.", "decided_by": "third reader" }, { "trial": "T121", "source": "library", "arms": { "Esketamine group": { "randomized": "87", "analysed": "85" }, "Control group (normal saline; PCIA without esketamine)": { "randomized": "87", "analysed": "84" } }, "depression": [ { "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative EPDS Score)", "values": { "Esketamine group": { "median": "12", "q1": "10", "q3": "13", "n": "85" }, "Control group (normal saline; PCIA without esketamine)": { "median": "12", "q1": "10.8", "q3": "14", "n": "84" } } }, { "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)", "day": 3, "form": "median_iqr", "location": "Table 2 (3 days postpartum, EPDS score)", "values": { "Esketamine group": { "median": "9.0", "q1": "7.0", "q3": "11.0", "n": "85" }, "Control group (normal saline; PCIA without esketamine)": { "median": "10.0", "q1": "8.8", "q3": "13.0", "n": "84" } } }, { "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)", "day": 3, "form": "count", "definition": "EPDS score ≥ 10", "location": "Table 2 (3 days postpartum, PPD risk)", "values": { "Esketamine group": { "events": "37", "n": "85" }, "Control group (normal saline; PCIA without esketamine)": { "events": "53", "n": "84" } } }, { "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)", "day": 42, "form": "median_iqr", "location": "Table 2 (6 weeks postpartum, EPDS score)", "values": { "Esketamine group": { "median": "6.0", "q1": "3.0", "q3": "9.0", "n": "85" }, "Control group (normal saline; PCIA without esketamine)": { "median": "7.0", "q1": "4.0", "q3": "11.3", "n": "84" } } }, { "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)", "day": 42, "form": "count", "definition": "EPDS score ≥ 10", "location": "Table 2 (Primary outcome, 6 weeks postpartum PPD risk)", "values": { "Esketamine group": { "events": "16", "n": "85" }, "Control group (normal saline; PCIA without esketamine)": { "events": "33", "n": "84" } } } ], "pain": [ { "measure": "NRS at rest (supine) at 24 and 48 h", "day": 1, "form": "median_iqr", "location": "Results 3.3, text (24 h; one value pair printed for 'NRS pain scores at rest and during coughing')", "values": { "Esketamine group": { "median": "3.0", "q1": "2.0", "q3": "4.0", "n": null }, "Control group (normal saline; PCIA without esketamine)": { "median": "4.0", "q1": "3.0", "q3": "5.0", "n": null } } }, { "measure": "NRS during coughing at 24 and 48 h", "day": 1, "form": "median_iqr", "location": "Results 3.3, text (24 h; one value pair printed for 'NRS pain scores at rest and during coughing')", "values": { "Esketamine group": { "median": "3.0", "q1": "2.0", "q3": "4.0", "n": null }, "Control group (normal saline; PCIA without esketamine)": { "median": "4.0", "q1": "3.0", "q3": "5.0", "n": null } } }, { "measure": "Cumulative sufentanil consumption (0-12, 12-24, 0-24, 24-48, 0-48 h)", "day": 1, "form": "mean_sd", "location": "Results 3.3, text (0–24 h)", "values": { "Esketamine group": { "mean": "33.5", "sd": "9.7", "n": null }, "Control group (normal saline; PCIA without esketamine)": { "mean": "48.2", "sd": "11.8", "n": null } } }, { "measure": "Cumulative sufentanil consumption (0-12, 12-24, 0-24, 24-48, 0-48 h)", "day": 2, "form": "mean_sd", "location": "Results 3.3, text (total 48-h consumption, 0–48 h)", "values": { "Esketamine group": { "mean": "59.4", "sd": "11.6", "n": null }, "Control group (normal saline; PCIA without esketamine)": { "mean": "75.5", "sd": "14.1", "n": null } } } ], "adverse_events": [ { "window": "intraoperative", "location": "Table 3 (Adverse effects during the operation)", "values": { "Esketamine group": { "dizziness": "27", "hallucination": "5", "nightmare": "2" }, "Control group (normal saline; PCIA without esketamine)": { "dizziness": "9", "hallucination": "0", "nightmare": "0" } } }, { "window": "postoperative", "location": "Table 3 (Adverse effects after surgery)", "values": { "Esketamine group": { "dizziness": "9", "hallucination": "2", "nightmare": "2" }, "Control group (normal saline; PCIA without esketamine)": { "dizziness": "2", "hallucination": "0", "nightmare": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2023-10-20", "end": "2024-06-16" }, "registration": { "number": "ChiCTR2300077191", "date": null }, "note": "Women with prenatal EPDS >= 10; esketamine 0.25 mg/kg after cord clamping plus 1.25 mg/kg in the PCIA. Randomized 87 and 87; analysed 85 and 84 (2 and 3 withdrew or were lost), the tables' column N. Baseline EPDS is the preoperative-interview score, median (Q1, Q3). Counts use the paper's PPD criterion, EPDS >= 10. Table 2's exploratory counts at other cut-offs are not entered (esketamine vs control, of 85 and 84): EPDS >= 13, day 3 11 vs 22, 6 weeks 5 vs 15; EPDS >= 12, day 3 13 vs 30, 6 weeks 7 vs 21; EPDS >= 11, day 3 22 vs 39, 6 weeks 12 vs 24. NRS: the text prints one value pair per time for 'NRS pain scores at rest and during coughing' without separating them, so the same 24-h pair is entered under both design measures; it is one printed pair, not two measurements. The 6-h and 12-h pairs fall outside the day windows, 48 h is only 'comparable (P > 0.05)', and Fig. 2 (captioned mean ± SD) has no printed values. Sufentanil in μg: 0-24 h entered as day 1 and the 0-48 h total as day 2; also printed, esketamine vs control: 0-12 h 17.7 ± 6.0 vs 27.6 ± 6.4, 12-24 h 15.8 ± 4.7 vs 20.6 ± 7.0, 24-48 h 25.9 ± 3.3 vs 27.4 ± 4.4; no n printed for pain. Postoperative adverse events cover the first 48 h. Enrollment dates are the screening period stated in Results ('From 20 October 2023 to 16 June 2024'); last follow-up July 28, 2024.", "decided_by": "third reader" }, { "trial": "T122", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "70", "analysed": "69" }, "Control group": { "randomized": "70", "analysed": "70" } }, "depression": [ { "measure": "PHQ-9 (>=10)", "day": -1, "form": "median_iqr", "location": "Table 1 (Preoperative PHQ-9 score)", "values": { "Esketamine group": { "median": "2", "q1": "0", "q3": "5", "n": "69" }, "Control group": { "median": "3.5", "q1": "1", "q3": "6", "n": "70" } } }, { "measure": "PHQ-9 (>=10)", "day": -1, "form": "count", "definition": "preoperative depressive symptom, PHQ-9 ≥ 10", "location": "Table 1 (Preoperative depressive symptom)", "values": { "Esketamine group": { "events": "7", "n": "69" }, "Control group": { "events": "9", "n": "70" } } }, { "measure": "PHQ-9 (>=10)", "day": 7, "form": "median_iqr", "location": "Table 4 (PHQ score, POD 7)", "values": { "Esketamine group": { "median": "3", "q1": "1", "q3": "6", "n": null }, "Control group": { "median": "4", "q1": "1", "q3": "7", "n": null } } }, { "measure": "PHQ-9 (>=10)", "day": 7, "form": "count", "definition": "postoperative depressive symptom, PHQ-9 ≥ 10", "location": "Table 4 (Postoperative depressive symptom, POD 7)", "values": { "Esketamine group": { "events": "9", "n": null }, "Control group": { "events": "10", "n": null } } } ], "pain": [ { "measure": "verbal NRS pain", "day": 1, "form": "median_iqr", "location": "Table 4 (NRS, 24 h)", "values": { "Esketamine group": { "median": "2", "q1": "1", "q3": "3", "n": "69" }, "Control group": { "median": "2", "q1": "1", "q3": "3", "n": "70" } } }, { "measure": "verbal NRS pain", "day": 2, "form": "median_iqr", "location": "Table 4 (NRS, 48 h)", "values": { "Esketamine group": { "median": "1", "q1": "1", "q3": "2", "n": "69" }, "Control group": { "median": "1", "q1": "1", "q3": "2", "n": "70" } } }, { "measure": "morphine consumption over 48 h", "day": 2, "form": "median_iqr", "location": "Table 4 (Morphine, 48 h (mg))", "values": { "Esketamine group": { "median": "6", "q1": "3", "q3": "8", "n": "69" }, "Control group": { "median": "3.5", "q1": "1", "q3": "8", "n": "70" } } } ], "adverse_events": [ { "window": "emergence", "values": { "Esketamine group": { "agitation": "4", "hallucination": "0", "nightmare": "0", "dissociation": "0", "visual": "0" }, "Control group": { "agitation": "1", "hallucination": "0", "nightmare": "0", "dissociation": "0", "visual": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2022-09", "end": "2024-09" }, "registration": { "number": "ChiCTR 2200062726", "date": "2022-08-16" }, "note": "Randomized per arm from Methods ('we enrolled 70 patients per group'); Results: 140 randomized, one esketamine patient lost to follow-up, 139 in the intention-to-treat analysis. PHQ-9 is reported both as scores (median, IQR) and as counts of PHQ-9 ≥ 10 at baseline and on POD 7; both are the design's one measure, 'PHQ-9 (>=10)', so each of those times has two entries under that name, one per form. Table 4's columns say n = 69 and 70, but the POD 7 percentages (9, 13.4%; 10, 14.5%) fit 67 and 69 assessed, so n is left null for the POD 7 entries; the other entries take the column n. Table 4 effects (esketamine vs control): PHQ score POD 7 median difference 0 (−1 to 1); depressive symptom POD 7 RR 0.92 (0.35 to 2.42); NRS 24 h 0 (0 to 0.5); NRS 48 h 0 (0 to 0); morphine 48 h 1 (0 to 3). Morphine over the first 48 h coded as day 2; NRS at 1 h and 2 h and morphine in PACU not coded. The preoperative PHQ-9 score was lower in the esketamine group (P = 0.036). Adverse events are for the PACU stay (Table 3), coded as window emergence: Delirium 4 (5.8) vs 1 (1.4) coded as agitation; the zeros for hallucination, nightmare, dissociation and diplopia come from the text ('No cases of hallucinations, nightmares, dissociation, diplopia, or low oxygen saturation were documented'); dizziness was planned but not reported. Subacute pain (POD 7) and chronic pain (3 months) are outside the coded days. Enrollment dates from Results.", "decided_by": "third reader" }, { "trial": "T123", "source": "library", "arms": { "Esketamine group": { "randomized": "60", "analysed": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "randomized": "60", "analysed": "55" } }, "depression": [ { "measure": "Hamilton Depression Scale (HAMD)", "day": -1, "form": "median_iqr", "location": "Table 1", "values": { "Esketamine group": { "median": "4", "q1": "3", "q3": "5.5", "n": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "median": "5", "q1": "3", "q3": "6", "n": "55" } } }, { "measure": "Hamilton Depression Scale (HAMD)", "day": 1, "form": "median_iqr", "location": "Table 3", "values": { "Esketamine group": { "median": "3", "q1": "2", "q3": "4", "n": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "median": "4", "q1": "2", "q3": "6", "n": "55" } } }, { "measure": "Hamilton Depression Scale (HAMD)", "day": 2, "form": "median_iqr", "location": "Table 4, POD two", "values": { "Esketamine group": { "median": "2", "q1": "2", "q3": "3", "n": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "median": "3", "q1": "2", "q3": "4", "n": "55" } } }, { "measure": "Hamilton Depression Scale (HAMD)", "day": 3, "form": "median_iqr", "location": "Table 4, POD three", "values": { "Esketamine group": { "median": "1", "q1": "0.5", "q3": "2", "n": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "median": "2", "q1": "1", "q3": "2", "n": "55" } } }, { "measure": "Hamilton Depression Scale (HAMD)", "day": 7, "form": "median_iqr", "location": "Table 4, POD seven", "values": { "Esketamine group": { "median": "1", "q1": "0", "q3": "2", "n": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "median": "1", "q1": "0", "q3": "2", "n": "55" } } } ], "pain": [ { "measure": "Number of PCIA attempts within 48 h (sufentanil PCIA)", "day": 2, "form": "median_iqr", "location": "Table 2 ('Number of PCIA Attempt (times)')", "values": { "Esketamine group": { "median": "0", "q1": "0", "q3": "2", "n": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "median": "1", "q1": "0", "q3": "3", "n": "55" } } }, { "measure": "Rescue analgesics (flurbiprofen axetil) within 48 h", "day": 2, "form": "count", "definition": "received rescue flurbiprofen axetil within 48 h", "location": "Table 2; Results, secondary outcomes (seven of 57 vs 17 of 55)", "values": { "Esketamine group": { "events": "7", "n": "57" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "events": "17", "n": "55" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 6 (monitored from the start of PCIA to POD 7)", "values": { "Esketamine group": { "dizziness": "3", "psychiatric_any": "0" }, "Sufentanil group (PCIA sufentanil 2 ug/kg only)": { "dizziness": "7", "psychiatric_any": "1" } } } ], "blinding_check": null, "enrollment": { "start": "2024-06", "end": "2024-11" }, "registration": { "number": "ChiCTR2400085319", "date": null }, "note": "Randomized 60 per group from Methods ('60 participants in each group were enrolled'); Results say 120 randomized and 8 excluded, leaving the per-protocol 57/55 (Figure 1 not in text). The text is a PDF extraction in which Table 2's esketamine column is printed apart from its rows; it was matched by row order (11 rows), which the text's rescue figures (seven of 57 vs 17 of 55, P = 0.016) and the P values confirm. The NRS rows in Tables 3 and 4 sit under 'Subjective sleep quality', and Methods define that NRS as sleep (0 = best possible sleep), so they are not entered as pain; the Discussion and the mediation analysis (Figure 7, 'NRS1') treat NRS on POD 1-2 as a pain score. If read as pain (sufentanil vs esketamine, median (IQR)): POD 1 3 (3 to 4) vs 3 (2 to 3.5); POD 2 3 (2 to 4) vs 2 (2 to 3); POD 3 2 (1 to 3) vs 2 (1 to 2); POD 7 1 (0 to 2) vs 1 (0 to 1). Postoperative pain NRS is otherwise not printed (Table 1's preoperative pain NRS is 3 (2 to 3) in both groups). PCIA attempts carry no time in Table 2; the PCIA ran 48 h, so day 2. 'Psychiatric symptoms' (Table 6) is a combined count, so psychiatric_any. Postoperative delirium within 3 days (3D-CAM, Table 5), 8 (14.5) vs 5 (8.8) sufentanil vs esketamine, is not mapped: it is a CAM diagnosis over three postoperative days, not agitation or excitement on emergence. Nausea/vomiting, drowsiness and pruritus have no codebook category. Enrollment is the study period in Methods (June 10 to November 30, 2024), which Results refer to ('during this period').", "decided_by": "third reader" }, { "trial": "T124", "source": "preprint", "arms": { "Group T (esketamine)": { "randomized": null, "analysed": "40" }, "Group C (saline)": { "randomized": null, "analysed": "40" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "mean_sd", "location": "Table 4 (EPDS scores, Preoperative Day)", "values": { "Group T (esketamine)": { "mean": "3.4", "sd": "1.8", "n": "40" }, "Group C (saline)": { "mean": "3.8", "sd": "1.8", "n": "40" } } }, { "measure": "EPDS", "day": 7, "form": "mean_sd", "location": "Table 4 (EPDS scores, 1 week post-op)", "values": { "Group T (esketamine)": { "mean": "5.3", "sd": "2.7", "n": "40" }, "Group C (saline)": { "mean": "6.5", "sd": "2.8", "n": "40" } } }, { "measure": "EPDS", "day": 7, "form": "count", "definition": "EPDS ≥ 13", "location": "Table 4 (Incidence of PPD, 1 week post-op)", "values": { "Group T (esketamine)": { "events": "3", "n": "40", "definition": "EPDS ≥ 13" }, "Group C (saline)": { "events": "10", "n": "40", "definition": "EPDS ≥ 13" } } }, { "measure": "EPDS", "day": 42, "form": "mean_sd", "location": "Table 4 (EPDS scores, 6 weeks post-op)", "values": { "Group T (esketamine)": { "mean": "4.3", "sd": "2.8", "n": "40" }, "Group C (saline)": { "mean": "5.6", "sd": "2.3", "n": "40" } } }, { "measure": "EPDS", "day": 42, "form": "count", "definition": "EPDS ≥ 13", "location": "Table 4 (Incidence of PPD, 6 weeks post-op)", "values": { "Group T (esketamine)": { "events": "2", "n": "40", "definition": "EPDS ≥ 13" }, "Group C (saline)": { "events": "8", "n": "40", "definition": "EPDS ≥ 13" } } } ], "pain": [ { "measure": "NRS at rest", "day": 1, "form": "mean_sd", "location": "Table 2 (Rest NRS score, 24h post-op)", "values": { "Group T (esketamine)": { "mean": "2.5", "sd": "1.1", "n": "40" }, "Group C (saline)": { "mean": "3.0", "sd": "1.3", "n": "40" } } }, { "measure": "NRS at rest", "day": 2, "form": "mean_sd", "location": "Table 2 (Rest NRS score, 48h post-op)", "values": { "Group T (esketamine)": { "mean": "2.0", "sd": "1.2", "n": "40" }, "Group C (saline)": { "mean": "2.5", "sd": "1.0", "n": "40" } } }, { "measure": "dynamic NRS", "day": 1, "form": "mean_sd", "location": "Table 2 (Dynamic NRS score, 24h post-op)", "values": { "Group T (esketamine)": { "mean": "3.6", "sd": "1.1", "n": "40" }, "Group C (saline)": { "mean": "4.2", "sd": "1.1", "n": "40" } } }, { "measure": "dynamic NRS", "day": 2, "form": "mean_sd", "location": "Table 2 (Dynamic NRS score, 48h post-op)", "values": { "Group T (esketamine)": { "mean": "3.0", "sd": "1.2", "n": "40" }, "Group C (saline)": { "mean": "3.6", "sd": "1.2", "n": "40" } } }, { "measure": "uterine contraction pain NRS", "day": 1, "form": "mean_sd", "location": "Table 2 (Uterine contraction pain NRS score, 24h post-op)", "values": { "Group T (esketamine)": { "mean": "3.1", "sd": "1.1", "n": "40" }, "Group C (saline)": { "mean": "3.7", "sd": "1.2", "n": "40" } } }, { "measure": "uterine contraction pain NRS", "day": 2, "form": "mean_sd", "location": "Table 2 (Uterine contraction pain NRS score, 48h post-op)", "values": { "Group T (esketamine)": { "mean": "2.7", "sd": "1.2", "n": "40" }, "Group C (saline)": { "mean": "3.3", "sd": "1.3", "n": "40" } } }, { "measure": "PCIA bolus requests (tramadol)", "day": 2, "form": "mean_sd", "location": "Table 2 (Number of rescue analgesia requests, 48h post-op)", "values": { "Group T (esketamine)": { "mean": "1.9", "sd": "1.4", "n": "40" }, "Group C (saline)": { "mean": "2.7", "sd": "1.4", "n": "40" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 5", "n": { "Group T (esketamine)": "40", "Group C (saline)": "40" }, "terms": { "dizziness": "Dizziness", "agitation": "Agitation/excitement", "any_ae": "Overall incidence of adverse events" }, "values": { "Group T (esketamine)": { "dizziness": "3", "agitation": "1", "any_ae": "19" }, "Group C (saline)": { "dizziness": "2", "agitation": "0", "any_ae": "16" } } } ], "blinding_check": null, "enrollment": { "start": "2024-10", "end": "2025-05" }, "registration": { "number": "ChiCTR2400090341", "date": "2024-09-27" }, "note": "Randomized per arm is not printed in the Results: 84 were randomized, 2 per group were converted to general anaesthesia and excluded, none was lost to follow-up, and 40 per group were analysed (all tables n = 40). The abstract instead says 80 were randomized, 40 per group, and Methods planned 44 per group (88 enrolled, 4 refused). Table 2's last row is labelled 'Number of rescue analgesia requests' (48 h only), but the Results text calls the same Table 2 result the number of PCIA bolus requests within 48 hours, so it is recorded under the design's PCIA measure; no 24 h value is given. Rest NRS at 2, 6, and 12 h is outside the day windows and left out. EPDS positive screen is EPDS ≥ 13 (Methods); the Results text's percentages (7.5% vs 25.0% at 1 week, 5.0% vs 20.0% at 6 weeks) match Table 4. Adverse events are Table 5's postoperative adverse reactions ('Agitation/excitement' recorded as agitation; 'Overall incidence of adverse events' as any_ae); nausea and vomiting (8 vs 8), pruritus (4 vs 3), shivering (4 vs 5), and somnolence (2 vs 1), Group T vs Group C, are not codebook categories. The abstract names blurred vision and irritability as slightly more frequent in Group T but gives no counts, and the Discussion says 'no severe adverse events including hallucinations, severe agitation or consciousness disturbance were recorded' (no count printed, so no hallucination zero is recorded). Enrollment dates are from Methods (October 2024 to May 2025). Registration date 27/09/2024 is from the abstract and Declarations, which call it retrospective, while Methods say it was registered before enrollment.", "decided_by": "third reader" }, { "trial": "T125", "source": "preprint", "arms": { "Esketamine group": { "randomized": "62", "analysed": "60" }, "Control group": { "randomized": "62", "analysed": "61" } }, "depression": [ { "measure": "EPDS", "day": -1, "form": "median_iqr", "location": "Table 3 (EPDS, Preoperative)", "values": { "Esketamine group": { "median": "4.0", "q1": "2.0", "q3": "4.0", "n": "60" }, "Control group": { "median": "4.0", "q1": "3.0", "q3": "4.0", "n": "61" } } }, { "measure": "EPDS", "day": 1, "form": "median_iqr", "location": "Table 3 (EPDS, 24 h)", "values": { "Esketamine group": { "median": "8.0", "q1": "6.0", "q3": "9.0", "n": "60" }, "Control group": { "median": "9.0", "q1": "8.0", "q3": "10.0", "n": "61" } } }, { "measure": "EPDS", "day": 3, "form": "median_iqr", "location": "Table 3 (EPDS, 72 h)", "values": { "Esketamine group": { "median": "3.0", "q1": "3.0", "q3": "4.0", "n": "60" }, "Control group": { "median": "6.0", "q1": "5.0", "q3": "6.0", "n": "61" } } } ], "pain": [ { "measure": "VAS at rest", "day": 1, "form": "median_iqr", "location": "Table 2 (Resting VAS, 24 h)", "values": { "Esketamine group": { "median": "2.0", "q1": "2.0", "q3": "2.0", "n": "60" }, "Control group": { "median": "2.0", "q1": "2.0", "q3": "2.0", "n": "61" } } }, { "measure": "VAS at rest", "day": 2, "form": "median_iqr", "location": "Table 2 (Resting VAS, 48 h)", "values": { "Esketamine group": { "median": "3.0", "q1": "2.0", "q3": "3.0", "n": "60" }, "Control group": { "median": "3.0", "q1": "3.0", "q3": "3.0", "n": "61" } } }, { "measure": "movement-evoked VAS", "day": 1, "form": "median_iqr", "location": "Table 2 (Movement-evoked VAS, 24 h)", "values": { "Esketamine group": { "median": "4.0", "q1": "3.0", "q3": "4.0", "n": "60" }, "Control group": { "median": "5.0", "q1": "4.0", "q3": "5.0", "n": "61" } } }, { "measure": "movement-evoked VAS", "day": 2, "form": "median_iqr", "location": "Table 2 (Movement-evoked VAS, 48 h)", "values": { "Esketamine group": { "median": "4.0", "q1": "3.0", "q3": "5.0", "n": "60" }, "Control group": { "median": "5.0", "q1": "4.0", "q3": "5.0", "n": "61" } } }, { "measure": "effective PCA presses", "day": 1, "form": "median_iqr", "location": "Table 2 (Effective PCA presses (n), 24 h)", "values": { "Esketamine group": { "median": "3.0", "q1": "2.0", "q3": "3.0", "n": "60" }, "Control group": { "median": "3.0", "q1": "3.0", "q3": "4.0", "n": "61" } } }, { "measure": "effective PCA presses", "day": 2, "form": "median_iqr", "location": "Table 2 (Effective PCA presses (n), 48 h)", "values": { "Esketamine group": { "median": "3.0", "q1": "3.0", "q3": "4.0", "n": "60" }, "Control group": { "median": "4.0", "q1": "3.0", "q3": "5.0", "n": "61" } } }, { "measure": "rescue butorphanol within 24 h", "day": 1, "form": "count", "definition": "rescue analgesia (IV butorphanol 1 mg for VAS > 5) within 24 h", "location": "Table 2 (24-h rescue analgesia, n (%))", "values": { "Esketamine group": { "events": "6", "n": "60", "definition": "rescue analgesia (IV butorphanol 1 mg for VAS > 5) within 24 h" }, "Control group": { "events": "15", "n": "61", "definition": "rescue analgesia (IV butorphanol 1 mg for VAS > 5) within 24 h" } } } ], "adverse_events": [ { "window": "overall", "location": "Table 5; Results, Adverse events", "n": { "Esketamine group": "60", "Control group": "61" }, "terms": { "dizziness": "Dizziness", "hallucination": "Hallucinations / nightmares", "nightmare": "Hallucinations / nightmares", "any_ae": "Total" }, "values": { "Esketamine group": { "dizziness": "1", "hallucination": "0", "nightmare": "0", "any_ae": "4" }, "Control group": { "dizziness": "2", "hallucination": "0", "nightmare": "0", "any_ae": "6" } } } ], "blinding_check": null, "enrollment": { "start": "2025-04", "end": "2025-12" }, "registration": { "number": "ChiCTR2500099435", "date": null }, "note": "Randomized 62 per group; withdrawn after randomization: 1 control (conversion to general anaesthesia) and 2 esketamine (intraoperative hemorrhage, intrauterine balloon), leaving 60 and 61 in every table. The text after the Results repeats the full preprint (abstract, methods, results, discussion) with the same numbers. EPDS was measured preoperatively and at 24 and 72 h (Table 3, median (P25, P75)); follow-up ended at 72 h, so no PPD incidence. Per-time n is the table header (missing data < 5%, available-case analysis). Pain: VAS at 2 and 6 h and PCA presses at 6 and 12 h are outside the day windows and left out; Table 2 doesn't say whether PCA presses at each time are cumulative. Rescue analgesia within 24 h: RD −14.6% (−27.8%, −1.4%) also printed. Adverse events (Table 5): the assessment window is not stated, so 'overall'; 'Hallucinations / nightmares' is one row (0 (0.0) in both arms, and the text says neither group had hallucinations or nightmares), recorded as hallucination 0 and nightmare 0; 'Total' recorded as any_ae; nausea and vomiting (3 vs 5), pruritus (0 vs 0), and respiratory depression (0 vs 0), esketamine vs control, are not codebook categories. Enrollment April to December 2025 is from the Results (Methods add that the last participant was assessed on December 2, 2025). Registered retrospectively; no registration date given.", "decided_by": "third reader" }, { "trial": "T126", "source": "preprint", "arms": { "Group R (ropivacaine ESP block)": { "randomized": "47", "analysed": "47" }, "Group K1 (low-dose esketamine)": { "randomized": "45", "analysed": "45" }, "Group K2 (high-dose esketamine)": { "randomized": "47", "analysed": "47" } }, "depression": [ { "measure": "HADS-D", "day": -1, "form": "mean_sd", "location": "Table 1 (Preoperative HADS-D score)", "values": { "Group R (ropivacaine ESP block)": { "mean": "4.6", "sd": "1.6", "n": "47" }, "Group K1 (low-dose esketamine)": { "mean": "4.3", "sd": "1.5", "n": "45" }, "Group K2 (high-dose esketamine)": { "mean": "4.8", "sd": "1.4", "n": "47" } } }, { "measure": "HADS-D", "day": 0.5, "form": "mean_sd", "location": "Table 3 (Postoperative HADS-D score, 12 h)", "values": { "Group R (ropivacaine ESP block)": { "mean": "4.1", "sd": "1.4", "n": "47" }, "Group K1 (low-dose esketamine)": { "mean": "3.9", "sd": "1.3", "n": "45" }, "Group K2 (high-dose esketamine)": { "mean": "4.4", "sd": "1.5", "n": "47" } } }, { "measure": "HADS-D", "day": 1, "form": "mean_sd", "location": "Table 3 (Postoperative HADS-D score, 24 h)", "values": { "Group R (ropivacaine ESP block)": { "mean": "3.3", "sd": "1.2", "n": "47" }, "Group K1 (low-dose esketamine)": { "mean": "2.9", "sd": "1.2", "n": "45" }, "Group K2 (high-dose esketamine)": { "mean": "3.3", "sd": "1.3", "n": "47" } } }, { "measure": "HADS-D", "day": 2, "form": "mean_sd", "location": "Table 3 (Postoperative HADS-D score, 48 h)", "values": { "Group R (ropivacaine ESP block)": { "mean": "2.9", "sd": "1.8", "n": "47" }, "Group K1 (low-dose esketamine)": { "mean": "2.9", "sd": "1.4", "n": "45" }, "Group K2 (high-dose esketamine)": { "mean": "3.1", "sd": "1.5", "n": "47" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "location": "Table 3 (Postoperative Dizziness and Dreamy, 12 h)", "values": { "Group R (ropivacaine ESP block)": { "dizziness": "5", "nightmare": "8" }, "Group K1 (low-dose esketamine)": { "dizziness": "5", "nightmare": "8" }, "Group K2 (high-dose esketamine)": { "dizziness": "3", "nightmare": "14" } } }, { "window": "postoperative", "location": "Table 3 (Postoperative Dizziness and Dreamy, 24 h)", "values": { "Group R (ropivacaine ESP block)": { "dizziness": "4", "nightmare": "4" }, "Group K1 (low-dose esketamine)": { "dizziness": "5", "nightmare": "5" }, "Group K2 (high-dose esketamine)": { "dizziness": "2", "nightmare": "4" } } }, { "window": "postoperative", "location": "Table 3 (Postoperative Dizziness and Dreamy, 48 h)", "values": { "Group R (ropivacaine ESP block)": { "dizziness": "9", "nightmare": "2" }, "Group K1 (low-dose esketamine)": { "dizziness": "10", "nightmare": "4" }, "Group K2 (high-dose esketamine)": { "dizziness": "6", "nightmare": "1" } } } ], "blinding_check": null, "enrollment": { "start": "2020-12-07", "end": "2021-04" }, "registration": { "number": "ChiCTR2000040659", "date": "2020-12-07" }, "note": "Esketamine was given perineurally in the ESP block (mixed with ropivacaine) after induction, not intravenously. Randomized numbers are the abstract's ('139 patients were randomized to group R (n = 47), K1 (n = 45) and K2 (n = 47)'), but Results say 150 recruited, 10 excluded, 'One patient withdrew from group K1. Thus, 139 patients randomized', so K1 may have had 46 randomized; tables use 47/45/47. HADS-D at 12 h coded as day 0.5. Pain: VAS at rest and on coughing (12, 24, 48 h) appear only in Fig. 3 (mean ± SD, no printed values); duration of ESP analgesia (R 784.2 ± 130.9, K1 845.0 ± 134.4, K2 894.5 ± 129.7 min) has no day; remedial analgesia (ketorolac, non-opioid) within 48 h, 31 (66) vs 21 (46.7) vs 9 (19.1); none entered. Adverse events (Table 3) are counts at each of 12, 24 and 48 h, not totals per participant, so they are entered as three postoperative entries told apart by location and should not be summed; 'Dreamy' coded as nightmare; nausea and vomiting not coded. Enrollment dates from Results ('All the cases came from December 7, 2020 to April 2021').", "decided_by": "both coders" } ]