[ { "id": "T009", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single bolus during etomidate/fentanyl induction", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (0.9% saline)", "role": "control" }, { "name": "Nonsurgical controls", "role": "other" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "cardiac surgery with cardiopulmonary bypass (CABG and/or valve)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Geriatric Depression Scale 15-item", "code": "GDS", "days": [ 7 ], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 52, "country": "USA", "centers": "single", "note": "Single ketamine 0.5 mg/kg IV bolus during anesthetic induction for cardiac surgery with CPB, so none and late_dosing false. GDS-15 belongs to the test battery given within a week before surgery and again 1 week after surgery or at discharge (whichever first), coded day 7. The 26 nonsurgical controls were not randomized (other). planned_n 52 = 26 per randomized group. Age >= 55, so adult." }, { "id": "T018", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": 160, "dose_note": "0.5 mg/kg IV 10 min after delivery; then PCIA ketamine 160 mg + sufentanil 100 ug in 100 mL, 2 mL/h background, 2 mL bolus, 8 min lockout", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section under spinal anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PPD at 6-8 weeks; postpartum blues at 4-6 days, EPDS > 9)", "code": "EPDS", "days": [ 5, 49 ], "primary": true } ], "pain_measures": [ { "measure": "NRS postoperative pain (unspecified)", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR-ROC-17012944", "date": null }, "enrollment": { "start": "2014-08", "end": "2016-12" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Ketamine 0.5 mg/kg IV 10 min after delivery under spinal anesthesia (awake), then a ketamine PCIA: some. Control got no injection and the same PCIA without ketamine (no study drug). EPDS > 9 defines PPD at 6-8 weeks and blues at 4-6 days; days are window midpoints. Only generic intraoperative adverse reactions recorded, so psychotomimetic_monitoring false. Registry ID printed as 'ChiCTR-ROC-17,012,944'." }, { "id": "T035", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "S-ketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": 0.125, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "bolus immediately after induction before incision; infusion until 15 min before end of surgery", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Saline group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "video-assisted thoracoscopic surgery (VATS)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 2 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "NRS during coughing", "code": "movement", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "rescue analgesia (IM bucinnazine) requirement", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100046552", "date": null }, "enrollment": { "start": "2021-05", "end": "2021-12" }, "ethics_approval": true, "planned_n": 80, "country": "China", "centers": "single", "note": "S-ketamine bolus after induction, infusion stopped 15 min before the end of surgery: all under GA (none), but the infusion ran into the last 30 min, so late_dosing true. All patients also had a surgeon-placed intercostal block before closure (general_and_regional). QoR-40 primary." }, { "id": "T045", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "0.25 mg/kg in 20 mL infused over 30 min after cord clamping; then PCIA esketamine 1.25 mg/kg + sufentanil 100 ug in 100 mL, 1 mL/h background, 2 mL bolus, 15 min lockout", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group (normal saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under spinal anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PPD risk, EPDS > 12)", "code": "EPDS", "days": [ 3, 42, 90, 180 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 1, 2 ], "primary": false }, { "measure": "NRS during coughing", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "cumulative sufentanil consumption", "code": "opioid", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100046049", "date": null }, "enrollment": { "start": "2021-05", "end": "2021-12" }, "ethics_approval": true, "planned_n": 150, "country": "China", "centers": "single", "note": "Esketamine 0.25 mg/kg infused over 30 min after cord clamping under spinal anesthesia (awake), then a postoperative esketamine PCIA: some. Control got saline and the same PCIA without esketamine." }, { "id": "T046", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Low-dose esketamine group (1 mg/kg esketamine PCIA)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "0.25 mg/kg over 10 min after delivery; then PCIA esketamine 1.0 mg/kg + sufentanil 2.2 ug/kg in 100 mL, continuous 2 mL/h for 48 h (~0.02 mg/kg/h)", "start": "after_delivery", "end": "after_emergence" }, { "name": "High-dose esketamine group (2 mg/kg esketamine PCIA)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "0.25 mg/kg over 10 min after delivery; then PCIA esketamine 2.0 mg/kg + sufentanil 2.2 ug/kg in 100 mL, continuous 2 mL/h for 48 h (~0.04 mg/kg/h)", "start": "after_delivery", "end": "after_emergence" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under spinal anesthesia", "depression_selection": "selected", "selection_criterion": "antenatal EPDS > 9", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (postpartum depressive symptoms, EPDS > 9)", "code": "EPDS", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS pain (unspecified)", "code": "other", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR-ROC-2000039069", "date": null }, "enrollment": { "start": "2020-12", "end": "2022-01" }, "ethics_approval": true, "planned_n": 300, "country": "China", "centers": "multi", "note": "Esketamine 0.25 mg/kg over 10 min after delivery under spinal anesthesia (awake), then 48 h continuous PCIA with esketamine: some. Placebo got 20 mL saline and sufentanil-only PCIA. Only women with antenatal EPDS > 9. CADSS at 40 min after infusion." }, { "id": "T048", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Group S", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single bolus injected after intubation", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Group C (normal saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "breast or thyroid surgery (women)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [], "pain_measures": [ { "measure": "VAS pain (unspecified)", "code": "other", "days": [ 1, 2, 3 ], "primary": true } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200060928", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "No depression measure: outcomes are SAS (anxiety) and VAS pain. Single S-ketamine 0.3 mg/kg after intubation under GA; late_dosing false assumes the operation outlasted 30 min after the post-intubation bolus. Only anesthesiologists are said to be blinded." }, { "id": "T051", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "S group (propofol with esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single dose given slowly with propofol 1.5-2 mg/kg at induction", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "P group (propofol)", "role": "control" }, { "name": "D group (propofol with dezocine)", "role": "other" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "dilatation and curettage for termination of pregnancy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain (unspecified)", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200058731", "date": null }, "enrollment": { "start": "2022-03", "end": "2022-08" }, "ethics_approval": true, "planned_n": 105, "country": "China", "centers": "single", "note": "Methods call it general anesthesia, but it is propofol TIVA with nasal-cannula oxygen and no airway device, i.e. the codebook's sedation (as for endoscopy), so some. Esketamine 0.3 mg/kg went in with propofol at induction of a brief D&C; if read as general: none with late_dosing true. Control (P) had no study drug but a higher propofol induction dose (2.5-3 vs 1.5-2 mg/kg). Delirium during and after recovery recorded as an adverse reaction." }, { "id": "T059", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Treatment Arm", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "0.5 mg/kg IV after loss of consciousness at induction; then 0.5 mg/kg/day added to sufentanil pump (1.5 mg/kg per 150 mL, meant for 3 days, up to 7 days) after each of the first 3 surgeries", "start": "at_induction", "end": "after_emergence" }, { "name": "Control Arm", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "burn debridement or skin grafting (burns >= 20% TBSA)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Self-rating Depression Scale (SDS), at discharge", "code": "SDS", "days": [], "primary": false } ], "pain_measures": [ { "measure": "subjective analgesic effectiveness (SAE), day 28 after admission or before discharge", "code": "other", "days": [], "primary": true }, { "measure": "NPR at rest (NPRr)", "code": "rest", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "NPR on movement (NPRm)", "code": "movement", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "daily opioid use (MME)", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2000034069", "date": "2020-06-22" }, "enrollment": { "start": "2020-09", "end": "2022-12" }, "ethics_approval": true, "planned_n": 60, "country": "China", "centers": "multi", "note": "Esketamine 0.5 mg/kg IV after the patient fell asleep at induction, plus esketamine in the postoperative sufentanil pump for days: some. SDS on admission and at discharge (no fixed day). Mental disorders recorded through day 28. Baseline table ignored." }, { "id": "T062", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group S", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": 0.5, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.5 mg/kg bolus in 20 mL at induction, then 0.5 mg/kg/h until end of surgery", "start": "at_induction", "end": "end_of_surgery" }, { "name": "Group C", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "modified radical mastectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 7, 90 ], "primary": false } ], "pain_measures": [ { "measure": "chronic postsurgical pain (NRS >= 3, rest or movement)", "code": "other", "days": [ 90 ], "primary": true }, { "measure": "NRS postoperative pain (unspecified)", "code": "other", "days": [ 0, 1 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300070728", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 72, "country": "China", "centers": "single", "note": "S-ketamine bolus at induction, then infusion until the end of surgery under GA: none, late_dosing true. Caution: the control saline bolus is described as given 10 min before induction; if the blinded syringes were given alike, the ketamine bolus may have started before induction (awake). Table ignored." }, { "id": "T064", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single bolus after induction, before incision; no other intraoperative ketamine allowed", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Placebo", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "major orthopedic surgery (spine, hip or knee arthroplasty, hip fixation, shoulder)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HADS depression score (>= 8)", "code": "HADS_D", "days": [ 7, 90 ], "primary": false } ], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 0, 1, 2, 3, 4, 5, 6, 7, 90 ], "primary": false }, { "measure": "cumulative opioid requirement, day 0-7", "code": "opioid", "days": [ 7 ], "primary": false }, { "measure": "neuropathic pain (DN4)", "code": "other", "days": [ 90 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT02892916", "date": "2016-09" }, "enrollment": { "start": "2017-03-20", "end": "2019-05-28" }, "ethics_approval": true, "planned_n": 274, "country": "France", "centers": "multi", "note": "Single ketamine 0.5 mg/kg IV bolus after induction, before incision, under GA (technique at each team's discretion): none, late_dosing false. Primary outcome changed mid-trial from delirium to delayed neurocognitive recovery at day 7. Hallucinations collected to day 7." }, { "id": "T067", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Low esketamine group (0.2 mg/kg)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single 10 mL injection during anesthesia", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "High esketamine group (0.5 mg/kg)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single 10 mL injection during anesthesia", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Control group (placebo)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "lung or mediastinal tumor resection with one-lung ventilation", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 3 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain (unspecified)", "code": "other", "days": [ 0, 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100047067", "date": null }, "enrollment": { "start": "2021-06", "end": "2022-07" }, "ethics_approval": true, "planned_n": 135, "country": "China", "centers": "single", "note": "Single esketamine injection 'during anesthesia' after induction (hemodynamics planned 5, 30 and 60 min after it, before the end of surgery): none, late_dosing false. Only CAM/MMSE cognitive outcomes; no psychotomimetic adverse events listed." }, { "id": "T068", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.5-0.7 mg/kg infused over at least 60 min; timing relative to surgery unclear", "start": "unclear", "end": "unclear" }, { "name": "SC-RPC group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "surgery for systemic tumors (women)", "depression_selection": "selected", "selection_criterion": "perioperative anxiety and depressive symptoms (DP1 low-medium, DP2 medium-high)", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9 (day before surgery only)", "code": "PHQ9", "days": [], "primary": false }, { "measure": "PHQ-15 (day before surgery only)", "code": "OTHER", "days": [], "primary": false }, { "measure": "MADRS (day before surgery only)", "code": "MADRS", "days": [], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2019", "end": "2021" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": null, "note": "Garbled Methods. 'SC-RPC' (apparently single-center randomized placebo-controlled) names both the trial and the comparator group, read as placebo. PHQ-9, PHQ-15 and MADRS are described only on the day before surgery, with no postoperative depression measure (an EEG/ML depression classifier is untimed), so no_depression_measure. Esketamine timing unclear (text also says patients 'received postoperative treatment with Esketamine'). Approval is from an 'Animal Ethics Committee'. Methods tables ignored." }, { "id": "T081", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single 0.3 mg/kg dose at induction; route not stated, given with the IV induction drugs", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Saline control", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective cardiac valve surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D (Chinese HADS, depression symptoms)", "code": "HADS_D", "days": [ 7, 30 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": null, "primary": false }, { "measure": "NRS during movement", "code": "movement", "days": null, "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT06608030", "date": null }, "enrollment": { "start": "2024-09-23", "end": "2025-03" }, "ethics_approval": true, "planned_n": 142, "country": "China", "centers": "multi", "note": "One esketamine bolus given at induction with midazolam, sufentanil and etomidate, so none; cardiac valve surgery lasts hours, so it ended long before the last 30 min (late false). Primary is HADS-D depression prevalence at POD 7, POD 30 secondary. Psychotomimetic: 'drug-related side effects within 3 days' recorded (types not listed) plus daily delirium screening. Pain NRS days not stated." }, { "id": "T093", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.375, "infusion_hours": 0.67, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg in 20 mL saline infused over 40 min (total 0.25 mg/kg)", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (20 mL normal saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "surgery under general anesthesia (type not given in text)", "depression_selection": "selected", "selection_criterion": "eligibility section missing from text; MADRS response and remission outcomes imply depressed participants", "age_group": null, "depression_measures": [ { "measure": "MADRS", "code": "MADRS", "days": [ 1, 2, 3, 4, 5, 28, 84 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at 48 h (severe pain = any NRS >= 7)", "code": "other", "days": [ 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": 108, "country": null, "centers": "single", "note": "PDF text lost the design and eligibility paragraphs (registration, ethics, country, ages, procedure not in text; country probably China, unstated). 40-min infusion started after skin incision under propofol-remifentanil TIVA, so all dosing under GA (none); surgery length not given, so whether it ended in the last 30 min is unclear. Primary: MADRS response (50% reduction) on POD 3." }, { "id": "T096", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine group", "role": "ketamine", "drug": "ketamine", "route": "oral", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "30 mg oral (in apple juice) every 8 h for 3 days, max 9 doses, or until discharge; body weight not given", "start": "postoperative", "end": "after_emergence" }, { "name": "Placebo group (normal saline)", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "multi-level lumbar spine decompression and fusion", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 7, 30 ], "primary": false } ], "pain_measures": [ { "measure": "NRS maximum, minimum and average pain over past 24 h", "code": "other", "days": [ 1, 7, 30 ], "primary": false }, { "measure": "daily opioid use in morphine equivalents (inpatient record, then phone)", "code": "opioid", "days": [ 1, 7, 30 ], "primary": false }, { "measure": "PROMIS pain interference", "code": "other", "days": [ 1, 7, 30 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT04646694", "date": "2020-11-30" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 40, "country": "Canada", "centers": "single", "note": "Oral ketamine started after surgery and taken awake for up to 3 days, so some (no dose under GA, late null). Anesthesia not stated; intraoperative care unrestricted, so intraoperative ketamine was allowed in both arms (only extra postoperative ketamine barred). Pilot: 40 adults 'included', no sample size calculation. Side effects by GASE, CNS included. Primary QoR-15." }, { "id": "T112", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.3, "infusion_hours": 0.67, "pump": false, "pump_total_mg": null, "dose_note": "0.2 mg/kg over 40 min (0.6 mL/kg/h of 0.5 mg/mL)", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (normal saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "major surgery expected to last over 2 h", "depression_selection": "selected", "selection_criterion": "PHQ-9 >= 10 and MADRS >= 22 before surgery", "age_group": "adult", "depression_measures": [ { "measure": "MADRS (remission <= 10, response, scores)", "code": "MADRS", "days": [ 3, 5 ], "primary": true } ], "pain_measures": [ { "measure": "moderate-to-severe pain (any NRS >= 4) within 72 h", "code": "other", "days": [ 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT04425473", "date": "2020-06-11" }, "enrollment": { "start": "2021-02-19", "end": "2024-06-20" }, "ethics_approval": true, "planned_n": 564, "country": "China", "centers": "multi", "note": "Methods never say when the 40-min infusion started, but place it under GA during surgery (unmasking for esketamine adverse events 'during surgery', intraoperative safety outcomes), so coded after induction and none. Surgery >2 h, so it likely ended well before the end, but with no start time late_dosing is null. Primary: MADRS remission POD 3; visits days 1, 2, 3, 5 and 1, 3, 6 months." }, { "id": "T115", "eligible": false, "exclusion_reason": "not_randomized", "timing_comparison": false, "arms": [ { "name": "ketamine-only (Study 1, healthy volunteers, laboratory)", "role": "other" }, { "name": "ketamine-GA (Study 2)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.75, "infusion_hours": 0.67, "pump": false, "pump_total_mg": null, "dose_note": "0.5 mg/kg over 40 min", "start": "after_induction", "end": "unclear" }, { "name": "placebo-GA (Study 2)", "role": "control" }, { "name": "Study 3 ketamine in participants with depression", "role": "other" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "elective surgery (Study 2 of a pooled EEG analysis)", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": "USA", "centers": "single", "note": "Secondary EEG analysis pooling three datasets. Only Study 2 (Stanford) is perioperative: ketamine (n=18) or placebo (n=19) infused intraoperatively under steady-state GA, but these Methods state no randomization and no depression measure (no_depression_measure also applies). Study 2's population and timing within surgery not described." }, { "id": "T121", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.5, "infusion_hours": 0.5, "pump": true, "pump_total_mg": null, "dose_note": "0.25 mg/kg in 20 mL over 30 min after cord clamping; then PCIA with 1.25 mg/kg esketamine + sufentanil 100 ug in 100 mL (1 mL/h basal, 2 mL bolus, 15-min lockout)", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group (normal saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery under spinal anesthesia", "depression_selection": "selected", "selection_criterion": "EPDS >= 10 at admission for delivery", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PPD = EPDS >= 10)", "code": "EPDS", "days": [ 3, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest (supine)", "code": "rest", "days": [ 1, 2 ], "primary": false }, { "measure": "NRS during coughing", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "cumulative sufentanil consumption (0-48 h)", "code": "opioid", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300077191", "date": null }, "enrollment": { "start": "2023-10", "end": "2024-06" }, "ethics_approval": true, "planned_n": 174, "country": "China", "centers": "multi", "note": "Awake under spinal for the 30-min esketamine infusion after cord clamping, then esketamine in the postoperative PCIA, so some (no GA, late null). Control got saline, then the same PCIA without esketamine. Primary: PPD (EPDS >= 10) at 6 weeks; EPDS also on day 3." }, { "id": "T123", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "PCIA only: 0.72 mg/kg esketamine + sufentanil 2 ug/kg in 100 mL, 2 mL/h background, 1 mL bolus, 15-min lockout, for 48 h", "start": "end_of_surgery", "end": "after_emergence" }, { "name": "Sufentanil group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "elderly total hip or knee arthroplasty", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HAMD", "code": "HAMD", "days": [ 1, 2, 3, 7 ], "primary": false } ], "pain_measures": [ { "measure": "pain NRS", "code": "other", "days": [ 1, 2, 3, 7 ], "primary": false }, { "measure": "number of PCIA attempts within 48 h", "code": "other", "days": [ 1, 2 ], "primary": false }, { "measure": "rescue analgesics (flurbiprofen) within 48 h", "code": "other", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400085319", "date": null }, "enrollment": { "start": "2024-06-10", "end": "2024-11-30" }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "Esketamine only in the postoperative PCIA, started at the end of suturing (still under GA, so late true) and run 48 h while awake, so some. Control: same sufentanil PCIA without esketamine, so inert. GA plus femoral and lateral femoral cutaneous nerve blocks. Called double-blind, but the list of blinded people omits patients, who drew their own envelope. Primary: sleep disturbance POD 1." } ]