[ { "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", "location": "Table 2 (also Results text)", "values": { "Group E": { "events": "2", "n": "58", "definition": "PPD: EPDS > 9 screen, then DSM-IV clinical interview" }, "Group C": { "events": "9", "n": "57", "definition": "PPD: EPDS > 9 screen, then DSM-IV clinical interview" } } }, { "measure": "DSM-IV clinical interview for PPD", "day": 42, "form": "count", "location": "Table 2 (also Results text)", "values": { "Group E": { "events": "3", "n": "58", "definition": "PPD: EPDS > 9 screen, then DSM-IV clinical interview" }, "Group C": { "events": "11", "n": "57", "definition": "PPD: EPDS > 9 screen, then DSM-IV clinical interview" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "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 reports one 'PPD' count per arm at 1 and 6 weeks: the two-step diagnosis (EPDS > 9 screen, then a clinical interview by DSM-IV criteria), so it is recorded under the DSM-IV measure; the number screening positive on the EPDS (> 9) alone is not reported, so the 'EPDS screen (>9)' measure has no entry. Table 2 percentages: C 15.8% and 19.3%, E 3.4% and 5.2% (matching the Results text). Randomized 60 per group (Study design); 3 excluded in C and 2 in E after randomization (bleeding > 500 mL, ovarian cyst surgery, failed anesthetic puncture), leaving 57 and 58 analysed. Adverse events (postpartum hemorrhage, nausea/vomiting, drowsiness, nightmares) were recorded within 48 hours after the operation; only nightmares fall under the codebook's categories (drowsiness is not dizziness). Enrollment dates are from Methods 2.2 and 2.5 (1 April to 30 November 2022); the Results don't restate them. Registered 30 May 2022, after enrollment began." }, { "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", "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", "location": "Table 3 (occurrence of postpartum depression)", "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", "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", "location": "Table 3 (occurrence of postpartum depression)", "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", "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", "location": "Table 3 (occurrence of postpartum depression)", "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", "values": { "S group": { "visual": "65", "dizziness": "63", "hallucination": "25" }, "C group": { "visual": "0", "dizziness": "0", "hallucination": "0" } } }, { "window": "intraoperative", "time": "15 min after administration", "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", "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 conflict: the flow text says 75 randomized per group, then 2 S and 4 C excluded for blood loss > 500 mL and 7 S and 8 C lost to follow-up, 129 analysed; Table 1 (N) and Table 2 (n) give S 66 and C 63, but Table 3 (the outcome table) heads C with n = 65. 'analysed' is 63 from Tables 1 and 2 and the flow; the per-entry n is Table 3's printed header (C 65). The C group's printed percentages in Table 3 (8 = 12.7%, adjuvant analgesia 19 = 30.2%) correspond to 63. EPDS is given in Table 3 both as mean ± SD and as the occurrence of PPD (EPDS ≥ 10, Methods 2.6) at each day, so each day has a mean_sd and a count entry. Pain: VAS was measured at 4 h (T1), 24 h (T2), and 48 h (T3); T1 is outside the day 1 and 2 windows and left out. Not extracted: 'Postoperative adjuvant analgesia' (S 2 (3.00%), C 19 (30.2%), Table 3), a count of patients needing extra analgesics with no time given. Adverse events are from Table 2 (side effects at 5 and 15 min after administration and on leaving the operating room); each time point is its own entry ('time' says which), and counts are participants at that time point. Table 2 gives nystagmus and diplopia separately (nystagmus S 65, 4, 0 and diplopia S 7, 1, 1 at 5 min, 15 min, and leaving the OR; C 0 throughout); 'visual' is the larger of the two at each time (nystagmus at 5 and 15 min, diplopia on leaving the OR), since participants with both can't be told apart, and the Results text also names blurred vision as more frequent at 5 min, but Table 2 gives no blurred-vision count. Dizziness on leaving the OR in S is printed '1 (0%)'. Drowsiness, lacrimation, nausea, vomiting, and Ramsay > 3 are not codebook categories. Enrollment dates are from Methods 2.2 (the Results don't restate them). Registered 15 February 2024, the day before enrollment began." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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", "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", "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", "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. 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 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." }, { "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", "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", "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." } ]