[ { "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 anesthetic induction", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (0.9% saline)", "role": "control" }, { "name": "Nonsurgical controls (not randomized)", "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": "Only dose: 0.5 mg/kg IV bolus during induction (etomidate/fentanyl, isoflurane GA) for CPB surgery lasting hours, so none and late false. GDS-15 is described within the test battery given within 1 week before and 1 week after surgery or at discharge (post-op GDS implied, day 7). Nonsurgical controls not randomized. Age >=55, so adult. planned_n = 26 per randomized group. Participant blinding not stated (equal-volume saline placebo)." }, { "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 diluted to 10 mL 10 min after delivery (route not stated, presumably IV); then PCIA ketamine 160 mg + sufentanil 100 ug in 100 mL, 2 mL/h, 2 mL bolus, 8 min lockout", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group (no injection; PCIA without ketamine)", "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", "code": "other", "days": [ 1, 2 ], "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": "Spinal anesthesia, awake: ketamine bolus 10 min after delivery plus ketamine in postoperative PCIA, so some. Control: no study drug, same spinal and PCIA minus ketamine. Both primary outcomes use EPDS > 9 (blues at 4-6 d, PPD at 6-8 wk; days coded as midpoints). Only generic intraoperative adverse reactions recorded, so psychotomimetic false. Registry ID printed with commas in the text." }, { "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 when coughing", "code": "movement", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "rescue analgesia requirement (IM bucinnazine)", "code": "opioid", "days": [ 2 ], "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": "GA, plus surgeon's intercostal nerve block before closure in all patients (general_and_regional). Esketamine bolus after induction and infusion ending 15 min before end of surgery, all under GA: none. Infusion ran into the last 30 min of surgery, so late true. Primary outcome QoR-40." }, { "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 IV over 30 min after cord clamping; PCIA esketamine 1.25 mg/kg + sufentanil 100 ug in 100 mL, 1 mL/h, 2 mL bolus, 15 min lockout", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group (saline; PCIA without esketamine)", "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", "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 0-48 h", "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": "Spinal anesthesia, awake: esketamine infused over 30 min after cord clamping plus esketamine in postoperative PCIA, so some. EPDS-3A anxiety subscale not counted." }, { "id": "T046", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Placebo group", "role": "control" }, { "name": "Low-dose esketamine group (1 mg/kg 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 in 20 mL over 10 min after delivery; then PCIA sufentanil 2.2 ug/kg + esketamine 1.0 mg/kg in 100 mL at 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 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 in 20 mL over 10 min after delivery; then PCIA sufentanil 2.2 ug/kg + esketamine 2.0 mg/kg in 100 mL at 2 mL/h for 48 h (~0.04 mg/kg/h)", "start": "after_delivery", "end": "after_emergence" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under spinal anesthesia (women with antenatal depressive symptoms)", "depression_selection": "selected", "selection_criterion": "antenatal EPDS > 9", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PDS = EPDS > 9; remission EPDS < 6; total score)", "code": "EPDS", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS postoperative pain", "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": "Spinal anesthesia, awake: esketamine over 10 min after delivery then 48 h esketamine PCIA, so some. Placebo got saline and sufentanil-only PCIA. CADSS dissociation at 40 min after infusion. Two centers." }, { "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 injection 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", "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), VAS pain, and adverse events. Single 0.3 mg/kg after intubation under GA, so none; tumor surgery assumed >30 min (duration not stated). Only anesthesiologists stated blinded." }, { "id": "T051", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "P group (propofol alone)", "role": "control" }, { "name": "D group (propofol with dezocine 0.08 mg/kg)", "role": "other" }, { "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": "0.3 mg/kg given slowly IV with propofol 1.5-2 mg/kg as induction; propofol 0.1 mg/kg/min maintenance", "start": "at_induction", "end": "before_end_of_surgery" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "dilatation and curettage (surgical 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 (pre- and postoperative)", "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": "Authors call it general anesthesia, but it is IV propofol with nasal-cannula O2 and spontaneous breathing, no airway device: sedation by the codebook (as for endoscopy), so some. Esketamine was given with the propofol induction of a brief D&C; if counted as general it would be none with late_dosing true (woke soon after the dose). Control got propofol alone at a larger induction dose (2.5-3 vs 1.5-2 mg/kg), no study drug. Delirium listed among recorded adverse reactions." }, { "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 the patient fell asleep during induction; plus 0.5 mg/kg/day in sufentanil PCIA (1.5 mg/kg in 150 mL, intended 3 days, up to 7); repeated for first 3 surgeries", "start": "at_induction", "end": "after_emergence" }, { "name": "Control Arm (saline)", "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 admission and discharge", "code": "SDS", "days": [], "primary": false } ], "pain_measures": [ { "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": "opioid use as daily morphine milligram equivalents", "code": "opioid", "days": [], "primary": false }, { "measure": "satisfaction with analgesic efficacy (SAE), day 28 after admission or before discharge", "code": "other", "days": [], "primary": true } ], "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": "Bolus after loss of consciousness at GA induction, but esketamine continued in the postoperative PCIA for days, so some. SDS post-procedure only at hospital discharge (day not fixed, days left empty). Presence of any mental disorder recorded within 28 days. Two centers." }, { "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 (0.9% saline)", "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": "CPSP incidence (NRS >= 3 at rest or movement) at 3 months", "code": "other", "days": [ 90 ], "primary": true }, { "measure": "postoperative NRS at 4 h and 24 h", "code": "other", "days": [ 0, 1 ], "primary": false }, { "measure": "rescue hydromorphone", "code": "opioid", "days": [], "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": "Group S bolus 'at induction' then infusion until end of surgery under GA: none, late true. Inconsistency: control saline bolus is described as '10 minutes before induction'; if the S-ketamine bolus was also pre-induction, conscious_dosing would be some." }, { "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 IV bolus after induction, before incision; no other intraoperative ketamine allowed", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (0.9% saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "major orthopedic surgery (spine, hip/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, daily to POD 7 and at 3 months", "code": "rest", "days": [ 0, 1, 2, 3, 4, 5, 6, 7, 90 ], "primary": false }, { "measure": "cumulative opioid requirements POD 0-7", "code": "opioid", "days": [ 7 ], "primary": false }, { "measure": "neuropathic pain (DN4) at 3 months", "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 bolus after induction and before incision of major orthopedic surgery under GA: none; given well before the end, so late false. Age >= 60. Primary outcome changed mid-trial from delirium to delayed neurocognitive recovery at day 7. Psychiatric events (hallucinations) collected to POD 7." }, { "id": "T067", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control group (placebo)", "role": "control" }, { "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 injection in 10 mL during anesthesia (route presumably IV)", "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 injection in 10 mL during anesthesia (route presumably IV)", "start": "after_induction", "end": "before_end_of_surgery" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "resection of lung or mediastinal tumors 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 at 2, 24, 48, 72 h", "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 bolus given during GA after induction; hemodynamics recorded 5, 30 and 60 min after the injection before the end-of-surgery time point, so it came >= 1 h before the end: none, late false. CAM/MMSE are cognitive outcomes, no psychotomimetic adverse-event recording stated. Double-blind; subjects and medical staff blinded." }, { "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 >= 60 min (1-3 mg/mL in 30-50 mL); timing relative to surgery unclear", "start": "unclear", "end": "unclear" }, { "name": "SC-RPC group (content unclear, likely placebo)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "surgery for tumors in women (type not stated)", "depression_selection": "selected", "selection_criterion": "perioperative anxiety/depression symptoms (DP1 low-medium, DP2 medium-high)", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [], "primary": false }, { "measure": "MADRS", "code": "MADRS", "days": [], "primary": false }, { "measure": "PHQ-15", "code": "OTHER", "days": [], "primary": false }, { "measure": "EEG-based classifier (depressive vs non-depressive)", "code": "OTHER", "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": "single", "note": "Methods incoherent (EEG/ML classifier text, human trial approved by an 'Animal Ethics Committee', jumbled criteria). PHQ-9/PHQ-15/MADRS stated only for the day before surgery; no post-procedure depression assessment stated. 'SC-RPC' read as single-center randomized placebo-controlled; control content and esketamine timing (text says both 'postoperative treatment' and induction drugs given 'after the Esketamine treatment') unclear. Selection unclear." }, { "id": "T081", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "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 group", "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 depression subscale (HADS-D, Chinese HADS)", "code": "HADS_D", "days": [ 7, 30 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest (days not stated)", "code": "rest", "days": [], "primary": false }, { "measure": "NRS during movement (days not stated)", "code": "movement", "days": [], "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 0.3 mg/kg dose given at induction of GA (midazolam, sufentanil, etomidate/propofol, vecuronium) for cardiac valve surgery, nothing later; so none, and late_dosing false (dose hours before the end of surgery). HADS-D is primary at POD 7 and secondary at POD 30. Psychotomimetic: drug-related side effects within 3 days (not itemized) plus daily delirium assessment. Three centers." }, { "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, "dose_note": "total 0.25 mg/kg in 20 mL saline, a single infusion over 40 min starting after skin incision", "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 stated in the text)", "depression_selection": "selected", "selection_criterion": "not stated (eligibility text missing); MADRS response and remission (<=10) outcomes imply depressive symptoms at baseline", "age_group": null, "depression_measures": [ { "measure": "MADRS (response = 50% reduction on POD 3; remission <=10)", "code": "MADRS", "days": [ 1, 2, 3, 4, 5, 28, 84 ], "primary": true } ], "pain_measures": [ { "measure": "NRS pain 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 with layout noise: the design, eligibility, registration, ethics and setting paragraphs are missing, hence nulls (ethics false = not stated; country not stated). The infusion ran under GA (propofol/remifentanil) for 40 min from skin incision, so none. Surgery type and length aren't given, so whether it ended >30 min before the end of surgery is unclear (late_dosing null; false if surgery ran >70 min after incision). depression_selection is inferred from the response/remission outcomes. YMRS, BPRS, CADSS, dizziness, delirium recorded." }, { "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, "dose_note": "30 mg oral (3 mL in 27 mL apple juice) every 8 h for 3 days/9 doses or until discharge; body weight not given", "start": "postoperative", "end": "after_emergence" }, { "name": "Placebo group (normal saline in apple juice)", "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 pain intensity (maximum, minimum, average over past 24 h)", "code": "other", "days": [ 1, 7, 30 ], "primary": false }, { "measure": "Opioid use (inpatient administration record; average daily use at follow-up calls), morphine equivalents", "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 or placebo every 8 h as postoperative analgesia in awake patients (with opioid PCIA), so some. Anesthesia for the surgery isn't stated ('no restrictions on intraoperative care'). PHQ-9 days are the stated follow-up contacts (POD 1, 7, 30); the text doesn't tie each measure to a day. planned_n is the 40 patients the pilot included (no sample size calculation). Primary outcome QoR-15. Side effects by the Generic Assessment of Side Effects Scale (CNS items)." }, { "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, "dose_note": "total 0.2 mg/kg: 0.6 mL/kg/h of 0.5 mg/mL over 40 min; start within surgery not stated", "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 >2 h", "depression_selection": "selected", "selection_criterion": "PHQ-9 >=10 and MADRS >=22 before surgery", "age_group": "adult", "depression_measures": [ { "measure": "MADRS (remission <=10 at POD 3 primary; response; scores at POD 3 and 5)", "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": "All participants had GA; the 40-min infusion's start isn't stated, but the Methods place it during surgery (unmasking for esketamine adverse events 'during surgery'), so none and start coded after_induction by inference. Surgery >2 h, but without the start time it's unclear whether the infusion ended >30 min before the end (late_dosing null). Ages 18-65 ('1865' in the text). Four hospitals. YMRS, BPRS, CADSS at 4 h, day 1, day 3." }, { "id": "T115", "eligible": false, "exclusion_reason": "not_randomized", "timing_comparison": false, "arms": [ { "name": "ketamine-only (Study 1, U-Michigan healthy volunteers, laboratory session)", "role": "other" }, { "name": "ketamine-GA (Study 2, Stanford)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.75, "infusion_hours": 0.67, "pump": false, "dose_note": "total 0.5 mg/kg over 40 min, intraoperatively under steady-state GA", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "placebo-GA (Study 2, Stanford)", "role": "control" }, { "name": "Study 3 (U-Auckland) participants with depression given ketamine", "role": "other" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "elective surgery under general anesthesia (type not stated)", "depression_selection": null, "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": "medRxiv EEG analysis pooling three studies, not a trial report. Only Study 2 (Stanford) is perioperative: 37 patients under steady-state GA given ketamine 0.5 mg/kg over 40 min (n=18) or placebo (n=19) intraoperatively. The Methods don't say allocation was random (first failing criterion) and name no depression measure after surgery. Studies 1 and 3 aren't perioperative or randomized arms, coded other. Country and centers refer to Study 2." }, { "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 at 40 mL/h over 30 min after cord clamping; then PCIA of esketamine 1.25 mg/kg + sufentanil 100 ug + ondansetron 8 mg in 100 mL (1 mL/h basal, 2 mL bolus, 15-min lockout); pump duration not stated", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group (normal saline; PCIA without esketamine)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery under spinal anesthesia in women with antenatal depressive symptoms", "depression_selection": "selected", "selection_criterion": "EPDS >=10 at admission for delivery", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)", "code": "EPDS", "days": [ 3, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest (supine) at 24 and 48 h", "code": "rest", "days": [ 1, 2 ], "primary": false }, { "measure": "NRS during coughing at 24 and 48 h", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "Cumulative sufentanil consumption (0-12, 12-24, 0-24, 24-48, 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": "Spinal anesthesia only (T6 block; cesarean inferred from cord clamping and surgery, the word isn't used). Esketamine infused after cord clamping in awake women and continued by postoperative PCIA, so some. Control got saline and the same PCIA without esketamine. EPDS-3A (anxiety) not coded. Two hospitals in Wuxi." }, { "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: esketamine 0.72 mg/kg + sufentanil 2 ug/kg in 100 mL, 2 mL/h background, 1 mL bolus, 15-min lockout, 48 h until exhausted (total 0.72 mg/kg)", "start": "end_of_surgery", "end": "after_emergence" }, { "name": "Sufentanil group (PCIA sufentanil 2 ug/kg only)", "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": "Hamilton Depression Scale (HAMD)", "code": "HAMD", "days": [ 1, 2, 3, 7 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain intensity (PODs 1, 2, 3, 7)", "code": "other", "days": [ 1, 2, 3, 7 ], "primary": false }, { "measure": "Number of PCIA attempts within 48 h (sufentanil PCIA)", "code": "opioid", "days": [ 1, 2 ], "primary": false }, { "measure": "Rescue analgesics (flurbiprofen axetil) 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 under GA and run 48 h in awake patients, so some; late_dosing true because the pump started at the end of surgery. Control is the same PCIA with sufentanil only (no study drug). GA plus femoral and lateral femoral cutaneous nerve blocks. 'Double-blind', but patients aren't named among those blinded. Primary outcome is sleep disturbance (AIS/NRS) on POD 1; the NRS days for pain are inferred from the listed POD 1, 2, 3, 7 scores. Results at the end of the text ignored." } ]