[ { "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, 1 week postpartum", "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, 1 week postpartum (Occurrence of postpartum depression); also Results text", "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, 2 weeks postpartum", "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, 2 weeks postpartum (Occurrence of postpartum depression); also Results text", "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, 1 month postpartum", "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, 1 month postpartum (Occurrence of postpartum depression); also Results text", "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, 2 days postpartum, NRS score, Wound pain; also Results text", "values": { "Ketamine": { "mean": "3.0", "sd": "0.9", "n": "153" }, "Placebo (saline)": { "mean": "4.0", "sd": "1.0", "n": "155" } } }, { "measure": "NRS score, contraction pain (uterine contraction pain)", "day": 2, "form": "mean_sd", "location": "Table 2, 2 days postpartum, NRS score, Contraction pain; also Results text", "values": { "Ketamine": { "mean": "3.0", "sd": "0.9", "n": "153" }, "Placebo (saline)": { "mean": "4.1", "sd": "0.9", "n": "155" } } } ], "adverse_events": [ { "window": "intraoperative", "timepoint": "5 min after dosing", "location": "Table 3", "values": { "Ketamine": { "hallucination": "24", "dizziness": "56" }, "Placebo (saline)": { "hallucination": "0", "dizziness": "0" } } }, { "window": "intraoperative", "timepoint": "15 min after dosing", "location": "Table 3", "values": { "Ketamine": { "hallucination": "6", "dizziness": "34" }, "Placebo (saline)": { "hallucination": "0", "dizziness": "2" } } }, { "window": "intraoperative", "timepoint": "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": "No baseline EPDS reported. The source never states whether '±' is SD; read as mean ± SD (form mean_sd). n per outcome is the Table 2 column header (Ketamine n = 153, Saline n = 155), which matches the analysed numbers in the Results; randomized 165 per arm (12 and 10 lost to follow-up). EPDS is given in two forms at each time (mean ± SD score and 'Occurrence of postpartum depression', defined in Methods as EPDS score > 9), so both are recorded as separate entries for the same day. Pain: the design lists one measure, 'NRS pain at 2 days', but Table 2 reports two NRS scores at 2 days postpartum, wound pain and uterine contraction pain; wound pain is recorded under the design's name and contraction pain under the source's own name. Adverse events: Table 3 gives counts at three assessment times during the operation (5 min and 15 min after the study drug, and before leaving the operating room), not the number of participants with each event across the operation, so each time is a separate entry (all intraoperative, spinal anaesthesia); the same participant may be counted at more than one time. Headache and vomiting are also reported but are not codebook categories. Spinal anaesthesia; ketamine 0.25 mg/kg or saline within 5 min after cord clamping." }, { "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 score > 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 score > 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: Methods (sample size) say 173 were randomly assigned to each group (346 in all; Results: 520 included, 174 excluded); this agrees with the flow in Results (control 173 - 9 propofol - 4 lost = 160; esketamine 173 - 8 propofol - 1 albinism - 5 lost = 159). Analysed 159 esketamine, 160 control (Results). Depression: no EPDS means or baseline are reported by arm; only PPD (EPDS > 9) by arm. Day 4: events printed in the text as 'Twenty-two' (esketamine, recorded as 22) and '37' (control), with percentages 13.8% vs 23.1%; n is not printed per time point, so the analysed numbers (159, 160) are given, which match the percentages. Day 42: the text gives only percentages (17% vs 25%), no counts, so they are recorded as form 'percent' with the analysed n for the code to convert; Fig. 2 has no printed values. Pain: NRS at 6, 12, 24 and 48 h is shown by arm only in Fig. 4, with no printed values (text: lower with esketamine at 6, 12 and 24 h, P < 0.05; 48 h P = 0.1730); Table 2's NRS values are by depressed vs non-depressed group, not by arm, so nothing is recorded. Adverse events: only the esketamine group's percentages are printed (dizziness 17.0%, blurred vision 5%, 'illusion' 3.8%, drowsiness 3.8%, all higher than control), with no counts and no control values (Fig. 6, not printed); recorded as percentages with a _percent suffix, not counts. 'Illusion' is taken as hallucination (Methods list 'hallucination' among recorded adverse reactions; Results call it illusion). Timing of adverse-event recording is not stated, so window 'overall'. Blinding: anesthesiologists could not be blinded because of esketamine's side effects; parturients and follow-up investigator blinded. Enrollment as the Results state it ('From July 2020 to September 2023'); Methods say the study was conducted from July 1, 2020 to July 21, 2023, with the last follow-up on September 1, 2023. Registration date printed as 20/11/2021, after the stated start of the study (July 2020); ethics approval dated 08/01/2021. Esketamine 0.2 mg/kg or saline pumped over 40 min from the beginning of the operation under combined spinal-epidural anaesthesia." }, { "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": "Randomized by arm is not printed: Results say 72 were randomized (1:1), then 2 excluded with preoperative pain, 1 with a psychiatric history and 1 declined, and the final analysis had 65 (group S n = 33, group C n = 32); 72 - 4 = 68, not 65, and Figure 1 (CONSORT) has no printed values here. The abstract instead says 72 were enrolled (group S, n = 33; group C, n = 32). Depression: PHQ-9 (preoperative, 1 week, 3 months) is shown only in Figure 4 with no printed values (text: no difference preoperatively; group S lower at 1 week and 3 months, P < .05); no baseline PHQ-9 in Table 1. Pain: NRS at rest and on movement at 4 h and 24 h appear only in Figures 2 and 3, no printed values. CPSP at 3 months (Table 2: 6 (18.2%) vs 14 (43.8%); abstract says 18.2% vs 48.3%) is outside the day 1-2 pain window and left out. Rescue hydromorphone: Table 1 'Rescue analgesic (N, %)' 6 (18%) group S vs 13 (41%) group C, with no time window stated, so left out of pain. Adverse events (Table 3, N = 33 vs 32): PONV 10 vs 8 not a codebook category; 'Dizzy' recorded as dizziness; 'Total(n)' 12 (36.4%) vs 10 (31.3%) recorded as any_ae (in group S it is less than the sum of the rows, so it counts patients); window postoperative (Methods list PONV, dizziness and hallucination as postoperative adverse events). No enrollment period stated anywhere; registration says 'registered before patient enrollment' with no date. Dose: Methods give S-ketamine 0.5 mg/kg bolus at induction then 0.5 mg/kg/h to end of surgery (figure captions agree), but the abstract says 1.5 mg/kg bolus then 2 mg/kg/h. General anaesthesia (propofol, remifentanil, sevoflurane, midazolam at induction)." }, { "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)); also 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 paragraph", "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 paragraph", "estimate": "-1.17", "se": "0.44", "lower": "-2.04", "upper": "-0.31", "level": "0.95", "scale": "mean_difference", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, Efficacy Outcomes paragraph", "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 paragraph", "estimate": "0.32", "se": "0.49", "lower": "-0.63", "upper": "1.28", "level": "0.95", "scale": "mean_difference", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 28, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, Efficacy Outcomes paragraph", "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 paragraph", "estimate": "0.24", "se": "0.52", "lower": "-0.78", "upper": "1.26", "level": "0.95", "scale": "mean_difference", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 42, "form": "count", "definition": "EPDS ≥ 10", "location": "Results, Efficacy Outcomes paragraph", "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 paragraph", "estimate": "-0.06", "se": "0.49", "lower": "-1.03", "upper": "0.91", "level": "0.95", "scale": "mean_difference", "values": { "Esketamine group": { "n": "148" }, "Control group": { "n": "150" } } } ], "pain": [], "adverse_events": [], "blinding_check": null, "enrollment": { "start": "2022-01-01", "end": "2023-01-01" }, "registration": { "number": "ChiCTR2100054199", "date": null }, "note": "150 randomized per arm; 2 women refused follow-up at postpartum day 5, leaving 148 esketamine and 150 control in the modified ITT analysis. Baseline EPDS was measured the day before surgery (day -1); the Table and the Results text give the same values. Counts are 'x of 148' vs 'x of 150' at every day (PPD = EPDS ≥ 10); day 7 also has OR 0.55 (95% CI 0.33-0.91), not recorded since counts are given. No per-arm EPDS means after surgery are printed (eTable 2 is in Supplement 2, not available); the continuous EPDS is given only as least-squares mean differences in change from baseline (mixed model for repeated measures with baseline EPDS as covariate), recorded as form 'change_difference' with the printed SE; sign as printed, negative favouring esketamine (presumably esketamine minus control). Day 7 effect size printed as 0.74. Minus signs printed as typographic minus or en dash (day 42 '–0.06') are written with an ASCII hyphen. Pain: NRS at rest has no printed values (similar at all times, eTable 3 / Figure 4 box plots); NRS on movement is printed only at 72 h (median 3.0 [IQR 2.0-3.0] vs 3.0 [IQR 3.0-3.5]), which is outside the day 1-2 window; no other pain numbers; postpartum pain sensitivity at day 7 not reported. Adverse events within 3 days (dizziness, headaches, somnolence, hallucinations, nightmares, nystagmus) are said not to differ but numbers are only in eTable 5 (not available). Esketamine 0.25 mg/kg plus midazolam 2 mg after delivery, then esketamine 50 mg in the PCIA pump (2 mL/h for 48 h); control received midazolam and saline, and the same pump without esketamine. Combined spinal-epidural anaesthesia." }, { "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 pain score ≥ 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 randomized 1:1; no withdrawals or protocol deviations, ITT analysis of all 136; per-arm n = 68 is printed in every table header (Control n=68, Esketamine n=68), so randomized and analysed are both 68. Tables list Control first, Esketamine second. HADS-D baseline is the preoperative value in Table 1 (patients screened one day before surgery), recorded as day -1. Table 3's median differences are printed positive (control minus esketamine) while the text gives them negative (e.g., HADS-D POD1 MD -1, 95% CI -2 to -1); per-arm medians are recorded, so no difference entries. HADS-A (anxiety) not recorded. Pain: POD1 recorded as day 1; 4 h, 8 h and POD3 are outside the day 1-2 window and left out. The primary outcome is defined in 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). Pain at POD1 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 recorded, the mean_se entries carrying the printed CI bounds as extra fields. Opioid: Table 3 gives total PCIA use with no time stated; the pump ran a background infusion for 48 hours, so it is recorded at day 2 as an inference (time not printed). Hydromorphone mg is recorded; PCIA volume, mL, median (IQR) is 87 (78-92) esketamine vs 93 (84.25-97.75) control (the same pump contents, 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] ug) are day 0 and left out. Adverse events (Table 9, postoperative): also 'Confusion and disorientation' 2 esketamine vs 3 control (listed under psychotomimetic reactions; not mapped, as it is not dissociation as the codebook defines it), delirium by 3D-CAM POD1-3 6 vs 7 (not mapped to agitation, which the codebook limits to delirium-like excitement on emergence), and nausea and vomiting 11 vs 21. No enrollment period is stated; registration date is from 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)." }, { "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", "sd": null, "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": 5, "form": "difference", "comparison": "Group A vs Group C", "location": "Discussion, fourth paragraph (Cohen's d)", "estimate": "0.58", "lower": null, "upper": null, "level": null, "scale": "cohens_d", "values": { "Group A": { "n": "62" }, "Group C": { "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", "sd": null, "n": "62" }, "Group B": { "mean": "3.00", "sd": "1.311", "n": "62" }, "Group C": { "mean": "4.18", "sd": null, "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 7, "form": "difference", "comparison": "Group A vs Group C", "location": "Discussion, fourth paragraph (Cohen's d)", "estimate": "0.82", "lower": null, "upper": null, "level": null, "scale": "cohens_d", "values": { "Group A": { "n": "62" }, "Group C": { "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", "sd": null, "n": "62" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "difference", "comparison": "Group A vs Group C", "location": "Discussion, fourth paragraph (Cohen's d)", "estimate": "0.70", "lower": null, "upper": null, "level": null, "scale": "cohens_d", "values": { "Group A": { "n": "62" }, "Group C": { "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 appear in the source only as captions with 'Download CSV / Display Table', so no table values are available; Figure 3 (adjusted EPDS means, SE bars) has no printed values. Randomized A 65, B 65, C 64; dropouts 3 (A), 2 (B), 3 (C), but the Results say the final analysis had 186 patients, 62 per group (65 - 2 = 63 and 64 - 3 = 61 do not match 62); analysed recorded as printed (62). n for each EPDS value is not printed per time; the 62 per group analysed is given. EPDS values come from the Discussion: the second paragraph gives 'mean ± x' at single time points (T1 = preoperative day 1, recorded as day -1; T2-T7 = postoperative days 3, 5, 7, 14, 30, 42); '±' is not labelled but is read as SD (an SE of 3.5 with n = 62 is impossible on a 0-30 scale). The third paragraph (MCID) prints group means inside subtractions: 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); arms were assigned to these by matching the second paragraph's values (C day 5 4.86, B day 5 3.51, B day 7 3.00, A day 14 1.88, B day 14 2.76), and they are recorded with sd null. Not printed: group B at baseline, 30 and 42 days; group A at day 3; group C at 30 and 42 days. Whether these are raw or model-adjusted means is not stated. Cohen's d (mean difference / pooled SD) printed positive for A vs C at days 5, 7, 14 (0.58, 0.82, 0.70), favouring group A (lower EPDS); A vs B at day 14 (0.58) not recorded as it compares two ketamine arms. No EPDS ≥ 9 counts by arm. Pain: VAS at 4, 12, 24, 48 h and PCIA bolus times are only in Table 3 (not available); text says VAS higher in group A than C at 4 h (p < 0.01), no differences at 12, 24, 48 h, and no rescue analgesia needed in any group. Adverse events: only percentages with any adverse event are printed (A 69.4%, B 30.6%, C 3.2%), recorded with a _percent suffix, not counts; Table 4 lists blurred vision, dizziness, drowsiness, nausea and vomiting, increased secretions, diplopia, hallucinations, hypertension and facial flushing, but its numbers are not available (text: blurred vision, dizziness and drowsiness differed, highest in group B). The Discussion says one patient in group B had transient psychiatric symptoms after administration, resolved with propofol 1 mg/kg (recorded as psychiatric_any 1 for group B only; other groups not stated). All side effects occurred during surgery or in the recovery room, none after transfer to the ward. 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." }, { "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", "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", "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" } } }, { "measure": "PCIA effective compression time (valid PCA presses)", "day": 1, "form": "mean_sd", "location": "Table 5 (On POD1, PCIA effective compression time)", "values": { "Post-ESK group": { "mean": "8.6", "sd": "6.4", "n": "37" }, "Pre-ESK group": { "mean": "6.4", "sd": "5.9", "n": "40" }, "Placebo group": { "mean": "11.3", "sd": "8.9", "n": "36" } } }, { "measure": "PCIA effective compression time (valid PCA presses)", "day": 2, "form": "mean_sd", "location": "Table 5 (On POD2, PCIA effective compression time)", "values": { "Post-ESK group": { "mean": "11.2", "sd": "7.0", "n": "37" }, "Pre-ESK group": { "mean": "9.4", "sd": "8.5", "n": "40" }, "Placebo group": { "mean": "14.6", "sd": "11.8", "n": "36" } } } ], "adverse_events": [ { "window": "postoperative", "timepoint": "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", "timepoint": "POD 1", "location": "Table 7", "values": { "Post-ESK group": { "dizziness": "17" }, "Pre-ESK group": { "dizziness": "16" }, "Placebo group": { "dizziness": "17" } } }, { "window": "postoperative", "timepoint": "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 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). Tables list Placebo, Pre-ESK, Post-ESK in that order. Preoperative values (the day before surgery) recorded as day -1. 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 the source's own 'depressive symptoms' is PHQ-9 ≥ 5 (bands 5-9 plus > 9), not printed as one number. Pain: the design's 'PCA pump presses' is recorded from 'PCIA compression time' (all presses); 'PCIA effective compression time' (valid presses, outside the lockout) is recorded under the source's name. QoR-15 not recorded. Adverse events (Table 7, 'Postoperative complications'): hallucination has no time given; dizziness is reported separately on POD 1 and POD 2 (the same patient may be counted on both days); nausea and vomiting also reported but not codebook categories. Enrollment: the Results give no dates; the Methods say the study took place between September 2021 and May 2023. Registration date printed as 05/09/2021, 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." }, { "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') not extracted. 48 randomized per group (Methods and CONSORT description). Analysed: Group C 45 (1 dropout for intractable hypertension, 2 declined callbacks), Group E 46 (2 dropouts for intractable hypertension); per-protocol analysis, missing data 7/144. Depression: HADS-D and Zung SDS (PRE, POD1, POD2) are shown only in Figures 2 (box plots) and 3 (bar graphs); the figure descriptions give approximate readings (e.g., HADS-D median '~7' vs '~6' on POD1; SDS bar 'about 54' vs 'about 49'), which are estimates from the chart, not printed values, so nothing is recorded. Text: on POD1 and POD2 Group E had lower HADS-D and SDS than Group C (POD1 P < 0.01; POD2 P < 0.001). Pain: VAS 24 h recorded as day 1 and 48 h as day 2 (Table 2, median (IQR) printed as 'median (q1, q3)'); VAS at 2, 4 and 8 h is day 0 and left out. Rescue ketorolac (Table 3, 'Number of requiring rescue analgesia': 2 (4.3%) Group E vs 9 (20%) Group C) was given in the PACU for VAS > 3, so it is outside the day 1-2 window and left out. Adverse events: Table 4 combines categories; 'Hallucinations or double vision' (1 vs 0) is recorded as psychiatric_any because it joins a hallucination and a visual event in one count; 'Dizziness or headache' (1 vs 2) is recorded as dizziness although it includes headache; nightmares printed as 0 in both. Also reported: PONV 1 vs 6, respiratory depression 0 vs 5, hypersomnia 1 vs 1, dry mouth 1 vs 0, flushing and sweating 0 vs 0. No enrollment dates are given; the trial was registered at ClinicalTrials.gov before enrollment, with no date. Esketamine 0.25 mg/kg over 10 min before induction then 0.25 mg/kg/h to the end of surgery, after midazolam 0.05 mg/kg in all groups; general anaesthesia." }, { "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 (HAMD, Preop); also Results text for group C", "values": { "ES1 group": { "mean": "8.0", "sd": "2.1", "n": "31" }, "ES2 group": { "mean": "8.0", "sd": "2.7", "n": "30" }, "C group": { "mean": "6.8", "sd": "2.7", "n": "30" } } }, { "measure": "HAMD", "day": 1, "form": "mean_sd", "location": "Table 4 (HAMD, 24 h postop); also Results text for group C", "values": { "ES1 group": { "mean": "6.2", "sd": "2.2", "n": "31" }, "ES2 group": { "mean": "7.1", "sd": "2.6", "n": "30" }, "C group": { "mean": "9.9", "sd": "3.7", "n": "30" } } }, { "measure": "HAMD", "day": 3, "form": "mean_sd", "location": "Table 4 (HAMD, 72 h postop); also Results text for group C", "values": { "ES1 group": { "mean": "5.2", "sd": "2.4", "n": "31" }, "ES2 group": { "mean": "5.6", "sd": "2.6", "n": "30" }, "C group": { "mean": "9.0", "sd": "3.5", "n": "30" } } } ], "pain": [ { "measure": "VAS at rest (24 h)", "day": 1, "form": "mean_sd", "location": "Table 5 (Resting VAS, 24 h postop)", "values": { "ES1 group": { "mean": "0.71", "sd": "0.82", "n": "31" }, "ES2 group": { "mean": "0.97", "sd": "1.00", "n": "30" }, "C group": { "mean": "0.62", "sd": "0.82", "n": "30" } } }, { "measure": "VAS on activity (24 h)", "day": 1, "form": "mean_sd", "location": "Table 6 (Activity VAS, 24 h postop)", "values": { "ES1 group": { "mean": "2.87", "sd": "1.34", "n": "31" }, "ES2 group": { "mean": "3.17", "sd": "1.39", "n": "30" }, "C group": { "mean": "2.93", "sd": "1.00", "n": "30" } } }, { "measure": "PCA bolus demands", "day": 1, "form": "mean_sd", "location": "Results, PCA bolus demands paragraph", "values": { "ES1 group": { "mean": "4.16", "sd": "2.60", "n": "31" }, "ES2 group": { "mean": "5.77", "sd": "6.59", "n": "30" }, "C group": { "mean": "4.69", "sd": "4.38", "n": "30" } } } ], "adverse_events": [ { "window": "postoperative", "timepoint": "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", "timepoint": "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 excluded from analysis (5 withdrew consent or family refused assessment at the preoperative evaluation the day before surgery, 3 intraoperative conversions; none received the study intervention); analysed per Table 3 headers: C 30, ES1 31, ES2 30, used as n for every outcome (Tables 4-7 print no n). Tables list Group C first. HAMD is HAMD-17 (Fig. 1 legend); 'Preop' (administered 24 h before surgery) recorded as day -1, '24 h postop' as day 1, '72 h postop' as day 3; the Results text repeats group C's values (6.8 ± 2.7, 9.9 ± 3.7, 9.0 ± 3.5), matching Table 4. Statistical analysis says continuous data are mean ± SD. The primary outcome (Table 2) is HAMA/HAMD score ≥ 8 at 24 h, but no counts by arm are printed. HAMA (anxiety) not recorded. Pain: VAS at 24 h recorded as day 1; 2 h, 6 h and 72 h are outside the window; superscript letters (within-group comparisons) dropped. 'PCA bolus demands' is not in the design; recorded under the source's name at day 1 because Table 2 lists 'Supplemental analgesia demands' for 0-24 h postop (the Results paragraph itself gives no time). The PCA contained sufentanil 2 ug/kg in all groups plus esketamine 1 mg/kg (ES1) or 2 mg/kg (ES2). Adverse events: Table 7 gives only the number with any adverse event at 24 h and at 48 h (recorded as any_ae, one entry each); 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; Methods inclusion criteria name surgery between May 1, 2023 and January 1, 2024. Registration date not given." } ]