[ { "trial": "T001", "source": "abstract", "source_record": "pmid:1729932", "records": [ "pmid:1729932" ], "design": { "id": "T001", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Ketamine 3 mg/kg", "role": "ketamine", "drug": "ketamine", "route": "oral", "bolus_mg_per_kg": 3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in cola drink as premedication", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Ketamine 6 mg/kg", "role": "ketamine", "drug": "ketamine", "route": "oral", "bolus_mg_per_kg": 6, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in cola drink as premedication", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "No ketamine (cola drink only)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "pediatric surgery (oral premedication)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adolescent", "depression_measures": [], "pain_measures": [], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Oral premedication before induction in children aged 1-7. Emotional state and emergence phenomena assessed; no depression measure." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 4.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T002", "source": "abstract", "source_record": "pmid:7573905", "records": [ "pmid:7573905" ], "design": { "id": "T002", "eligible": false, "exclusion_reason": "no_inert_control", "timing_comparison": false, "arms": [ { "name": "Control group (local anaesthesia + saline)", "role": "control" }, { "name": "P/M (pentazocine + midazolam)", "role": "other", "dose_note": "pentazocine 0.40 mg/kg + midazolam 0.075 mg/kg iv" }, { "name": "K25/M (ketamine + midazolam)", "role": "other", "dose_note": "ketamine 0.25 mg/kg + midazolam 0.075 mg/kg iv before local anaesthesia" }, { "name": "K50/M (ketamine + midazolam)", "role": "other", "dose_note": "ketamine 0.5 mg/kg + midazolam 0.075 mg/kg iv before local anaesthesia" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "day-case maxillofacial (dental) surgery under local anaesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Ketamine was given only with midazolam for conscious sedation; the saline control got no midazolam, so no inert arm matches a ketamine arm. No depression measure either (STAI is anxiety)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": null, "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T003", "source": "abstract", "source_record": "pmid:9620513", "records": [ "pmid:9620513" ], "design": { "id": "T003", "eligible": false, "exclusion_reason": "not_randomized", "timing_comparison": false, "arms": [ { "name": "Ketamine (PCEA with ketamine 0.4 mg/mL)", "role": "ketamine", "drug": "ketamine", "route": "epidural", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "0.4 mg/mL added to PCEA morphine-bupivacaine-epinephrine", "start": "postoperative", "end": "after_emergence" }, { "name": "Control (PCEA without ketamine)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "major surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "VAS during cough or movement", "code": "movement", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "VAS at rest", "code": "rest", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "consumption of PCEA analgesics", "code": "other", "days": [ 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "The abstract never says allocation was random. Ketamine only in the postoperative PCEA. No depression measure." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": true, "size": null, "registration_shared_with": [] }, { "trial": "T004", "source": "abstract", "source_record": "pmid:11375826", "records": [ "pmid:11375826" ], "design": { "id": "T004", "eligible": false, "exclusion_reason": "not_randomized", "timing_comparison": false, "arms": [ { "name": "Coadministration group (propofol + ketamine)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.22, "infusion_hours": null, "pump": false, "dose_note": "mean 3.7 +/- 1.5 ug/kg/min with propofol during monitored anesthesia care", "start": "at_induction", "end": "unclear" }, { "name": "Propofol group", "role": "control" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "surgery under monitored anesthesia care", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "five-point pain rating after discharge, evenings for 5 days", "code": "other", "days": [ 0, 1, 2, 3, 4 ], "primary": false }, { "measure": "analgesic consumption after discharge", "code": "other", "days": [ 0, 1, 2, 3, 4 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Random allocation not stated. Ketamine infused with propofol sedation (start of sedation coded at_induction). Mood VAS only, no depression scale." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T005", "source": "abstract", "source_record": "pmid:12088953", "records": [ "pmid:12088953" ], "design": { "id": "T005", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group A (ketamine)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 1.0, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "with propofol and fentanyl at induction", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group B (propofol and fentanyl)", "role": "control" }, { "name": "Group C (non-depressed controls, not randomized)", "role": "other" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "orthopedic surgery", "depression_selection": "selected", "selection_criterion": "major depression", "age_group": null, "depression_measures": [ { "measure": "Hamilton Depression Rating (HDR) score", "code": "HAMD", "days": [ 1 ], "primary": false } ], "pain_measures": [ { "measure": "postoperative pain score at 8 and 16 h", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Single 1.0 mg/kg dose as part of induction under GA, nothing later, so conscious none and late false. HDR timing (2 days before, 1 day after surgery) read from the abstract. Group C is a non-randomized, non-depressed comparison." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 1.0, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T006", "source": "abstract", "source_record": "pmid:15105223", "records": [ "pmid:15105223" ], "design": { "id": "T006", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Placebo", "role": "control" }, { "name": "Single S(+)-ketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "preincisional", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Repeated S(+)-ketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "preincisional, then 0.2 mg/kg every 20 min intraoperatively", "start": "after_induction", "end": "unclear" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "major abdominal (visceral) surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "pain scores after awakening, 3 and 6 h", "code": "other", "days": [ 0 ], "primary": false }, { "measure": "additional diclofenac and dextropropoxyphene consumption at 24 h", "code": "other", "days": [ 1 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Mood after awakening appears only as a result; no depression measure named. Preincisional doses read as after induction under combined general and epidural anesthesia; when the repeated doses stopped is not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 1.0, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T007", "source": "abstract", "source_record": "pmid:17894912", "records": [ "pmid:17894912" ], "design": { "id": "T007", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Ketamine", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.15, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "intraoperative bolus, then PCA ketamine 0.5 mg per 1 mg morphine", "start": "after_induction", "end": "after_emergence" }, { "name": "Placebo", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "major gynaecological abdominal surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "morphine consumption over 24 h (main end-point), titration and 48-h PCA period", "code": "opioid", "days": [ 1, 2 ], "primary": true } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Psychometric tests are cognitive; no depression measure. Ketamine continued by postoperative PCA." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.15, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T008", "source": "abstract", "source_record": "pmid:17583431", "records": [ "pmid:17583431" ], "design": { "id": "T008", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Group K (epidural ketamine + bupivacaine)", "role": "ketamine", "drug": "ketamine", "route": "epidural", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": null, "dose_note": "epidural infusion after the combined spinal-epidural; rate and duration not stated", "start": "after_induction", "end": "unclear" }, { "name": "Group S (epidural saline + bupivacaine)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "lower limb amputation", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "incidence and severity of stump and phantom pain over 12 months", "code": "other", "days": [], "primary": true } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Combined spinal-epidural, no GA; epidural ketamine infusion began after the block (pre-emptive), so awake. Mood appears only in the results; no depression measure named." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T009", "source": "library", "source_record": "pmid:19422355", "records": [ "pmid:19422355" ], "design": { "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)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 52, "registration_shared_with": [] }, { "trial": "T010", "source": "fulltext", "source_record": "pmid:27212773", "records": [ "pmid:27212773" ], "design": { "id": "T010", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Group D (intranasal dexmedetomidine)", "role": "control" }, { "name": "Group DK (dexmedetomidine + ketamine)", "role": "ketamine", "drug": "ketamine", "route": "intranasal", "bolus_mg_per_kg": 2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "with dexmedetomidine 1 ug/kg intranasal, 30 min before surgery", "start": "before_induction", "end": "before_end_of_surgery" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "elective minor pediatric surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adolescent", "depression_measures": [], "pain_measures": [], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2014-01", "end": "2015-01" }, "ethics_approval": true, "planned_n": null, "country": "India", "centers": "single", "note": "Add-on design (dexmedetomidine in both arms). Intranasal premedication 30 min before induction, awake. Outcomes are separation anxiety, mask acceptance, sedation and emergence agitation; no depression measure." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 2.0, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T011", "source": "abstract", "source_record": "pmid:26582047", "records": [ "pmid:26582047" ], "design": { "id": "T011", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group K", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": 0.25, "infusion_hours": 0.5, "pump": false, "dose_note": "bolus at induction, then infusion for 30 min", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group C", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective orthopedic surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 5 ], "primary": false } ], "pain_measures": [ { "measure": "postoperative VAS pain scores", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Bolus at induction and a 30-min infusion, all under GA. Dosing stopped about 30 min after induction, before the end of elective orthopedic surgery (length not stated), so late false." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.625, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T012", "source": "registry", "source_record": "nct:NCT02424591", "records": [ "nct:NCT02424591" ], "design": { "id": "T012", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.6, "infusion_hours": null, "pump": false, "dose_note": "10 ug/kg/min from after intubation to the start of skin closure; no bolus stated", "start": "after_induction", "end": "end_of_surgery" }, { "name": "Placebo", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "multilevel posterior spinal fusion", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Beck's Depression Inventory", "code": "BDI", "days": [ 3 ], "primary": false } ], "pain_measures": [ { "measure": "McGill Short Form (with Present Pain Intensity)", "code": "other", "days": [ 3 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": false, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT02424591", "date": "2015-04-02" }, "enrollment": { "start": "2014-08", "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Registry entry (46 actually enrolled). Infusion under GA from after intubation until skin closure began, so it ran to the end of surgery: late true. Masking listed as outcomes assessor only." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2015, "registry_dates": { "first_submitted": "2015-04-02", "start": "2014-08" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T013", "source": "registry", "source_record": "nct:NCT02422303", "records": [ "nct:NCT02422303" ], "design": { "id": "T013", "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": false, "dose_note": "at induction of general anesthesia", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "No ketamine group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "procedure under general anesthesia (not named)", "depression_selection": "selected", "selection_criterion": "history of or current depression, Goldberg screen >=5", "age_group": null, "depression_measures": [ { "measure": "Goldberg Depression Screening Test", "code": "OTHER", "days": [ 7 ], "primary": true } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": false }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT02422303", "date": "2015-04-16" }, "enrollment": { "start": "2015-12", "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Registry record; terminated with 12 enrolled. No-intervention control. Procedure and its length not stated, so late_dosing null. Registry masks participant and care provider, not the assessor." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": 2015, "registry_dates": { "first_submitted": "2015-04-16", "start": "2015-12" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T014", "source": "abstract", "source_record": "pmid:29275607", "records": [ "pmid:29275607" ], "design": { "id": "T014", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group K", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "0.5 mg/kg in 250 mL saline over 1 h, once daily for 7 days", "start": "unclear", "end": "after_emergence" }, { "name": "Group C", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "breast cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "Hospital Anxiety and Depression Scale (HADS)", "code": "HADS_TOTAL", "days": [ 5, 90, 180 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain in PACU, at 4 h, 24 h and days 2-5", "code": "other", "days": [ 0, 1, 2, 3, 4, 5 ], "primary": false }, { "measure": "analgesic requirement", "code": "other", "days": [], "primary": false }, { "measure": "PMPS incidence and pain level at 3 and 6 months", "code": "other", "days": [ 90, 180 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": "2015-06", "end": "2016-05" }, "ethics_approval": false, "planned_n": null, "country": "China", "centers": "single", "note": "Daily 1-h infusions for 7 days, so most doses were given awake after surgery; when the first was given relative to surgery is not stated. HADS named without subscales." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T015", "source": "abstract", "source_record": "pmid:28357557", "records": [ "pmid:28357557" ], "design": { "id": "T015", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "within 5 min after umbilical cord clamping", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Placebo (saline)", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "cesarean", "procedure": "caesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS), threshold 9/10", "code": "EPDS", "days": [ 3, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS pain", "code": "other", "days": [ 3, 42 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Anesthesia for the cesarean is not stated, so whether the post-clamping dose was given awake (neuraxial) or under GA is unclear." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.25, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T016", "source": "fulltext", "source_record": "pmid:30336852", "records": [ "pmid:30336852" ], "design": { "id": "T016", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Lo-K", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "after induction, before incision", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Hi-K", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 1.0, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "after induction, before incision", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (P)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "major open cardiac or non-cardiac surgery in older adults", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "PHQ-8", "code": "PHQ9", "days": [ 3, 30 ], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT01690988", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 600, "country": "USA, Canada, South Korea, India", "centers": "multi", "note": "PODCAST secondary analysis. Single bolus after induction and before incision for major surgery, so late false. PHQ-8 at POD3 is this analysis's primary outcome, but PODCAST's primary was delirium, so primary false. planned_n is PODCAST's target." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2012, "registry_dates": { "first_submitted": "2012-08-07", "start": "2014-02-01" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.75, "pump_only": false, "size": 600, "registration_shared_with": [] }, { "trial": "T017", "source": "abstract", "source_record": "pmid:29947916", "records": [ "pmid:29947916" ], "design": { "id": "T017", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group K (ketamine)", "role": "other", "dose_note": "ketamine 0.5 mg/kg iv without the dexamethasone the control gets" }, { "name": "Group D (dexamethasone)", "role": "control" }, { "name": "Group KD (ketamine + dexamethasone)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "with dexamethasone 0.1 mg/kg, 5 min after induction", "start": "after_induction", "end": "before_end_of_surgery" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "gynecologic surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 3 ], "primary": false } ], "pain_measures": [ { "measure": "postoperative VAS pain", "code": "other", "days": [], "primary": false }, { "measure": "PCA consumption", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "No placebo arm: group D (dexamethasone) is the control for group KD, which adds only ketamine; group K lacks dexamethasone, so other. Single bolus 5 min after induction, so late false (surgery length not stated)." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T018", "source": "library", "source_record": "pmid:31147085", "records": [ "pmid:31147085" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2017, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T019", "source": "abstract", "source_record": "pmid:30095550", "records": [ "pmid:30095550" ], "design": { "id": "T019", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Ketamine", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.4, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single dose given as an infusion in the PACU", "start": "after_emergence", "end": "after_emergence" }, { "name": "Placebo (saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "laparoscopic gastric bypass and gastrectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 0 ], "primary": true }, { "measure": "short-form McGill Pain Questionnaire", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2014-10", "end": "2018-01" }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "single", "note": "The objective mentions mood scores, but the outcome measures listed are pain only and no depression measure is named. Dose given in the PACU after emergence; GA implied by laparoscopic surgery." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T020", "source": "fulltext", "source_record": "pmid:32812388", "records": [ "pmid:32812388" ], "design": { "id": "T020", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "slow injection within 5 min after cord clamping", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Placebo (saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 7, 14, 30 ], "primary": true } ], "pain_measures": [ { "measure": "NRS pain at 2 days", "code": "other", "days": [ 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR1900022464", "date": null }, "enrollment": { "start": "2019-06-26", "end": "2019-07-15" }, "ethics_approval": true, "planned_n": 330, "country": "China", "centers": "single", "note": "Spinal anesthesia; bolus after cord clamping while awake." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2019, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.25, "pump_only": false, "size": 330, "registration_shared_with": [] }, { "trial": "T021", "source": "fulltext", "source_record": "pmid:32565534", "records": [ "pmid:32565534" ], "design": { "id": "T021", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control group", "role": "control" }, { "name": "Racemic ketamine group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 50 mL, 1 h after induction", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "High-dose S-ketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 50 mL, 1 h after induction", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Low-dose S-ketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 50 mL, 1 h after induction", "start": "after_induction", "end": "before_end_of_surgery" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "laparoscopic modified radical hysterectomy for cervical cancer", "depression_selection": "selected", "selection_criterion": "preoperative HAMD-17 8-24", "age_group": null, "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 1, 2, 3, 5, 7 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 1, 2, 3, 5, 7 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2015-04", "end": "2018-07" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Single dose 1 h after induction ('after 1 h of analgesia') during a long laparoscopic radical hysterectomy under GA, so late false." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "mixed", "dose_ketamine_equivalent_mg_per_kg": 0.667, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T022", "source": "fulltext", "source_record": "pmid:35172727", "records": [ "pmid:35172727", "ppr:PPR433377" ], "design": { "id": "T022", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "C group", "role": "control" }, { "name": "S group (S-ketamine)", "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": "0.5 mg/kg in 100 mL PCIA with sufentanil; basal 2 mL/h plus 1-mL boluses for 48 h", "start": "end_of_surgery", "end": "after_emergence" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 3, 14, 28 ], "primary": true } ], "pain_measures": [ { "measure": "VAS at 4, 8, 12, 24 and 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100050263", "date": "2021-08-24" }, "enrollment": { "start": "2019-09-01", "end": "2020-07-15" }, "ethics_approval": true, "planned_n": 375, "country": "China", "centers": "single", "note": "Esketamine only in the postoperative PCIA, started after skin closure, under spinal anesthesia: awake. Registered retrospectively." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 375, "registration_shared_with": [] }, { "trial": "T023", "source": "abstract", "source_record": "pmid:34807494", "records": [ "pmid:34807494" ], "design": { "id": "T023", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group C", "role": "control" }, { "name": "Group K", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": 0.25, "infusion_hours": null, "pump": false, "dose_note": "after completion of induction until the end of surgery", "start": "after_induction", "end": "end_of_surgery" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "modified radical mastectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "Hospital Anxiety and Depression Scale (HADS)", "code": "HADS_TOTAL", "days": [ 2, 90 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at 4, 24 and 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "chronic pain at 3 months", "code": "other", "days": [ 90 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "single", "note": "Bolus after induction and infusion until the end of surgery under GA: late true. HADS named without subscales." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T024", "source": "fulltext", "source_record": "pmid:34736438", "records": [ "pmid:34736438", "ppr:PPR380652" ], "design": { "id": "T024", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "R (ropivacaine alone)", "role": "control" }, { "name": "RS (ropivacaine with IV S-ketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.15, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "1 min before incision, after the combined spinal-epidural", "start": "after_induction", "end": "before_end_of_surgery" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective caesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS at discharge", "code": "EPDS", "days": [], "primary": false } ], "pain_measures": [ { "measure": "analgesic effect at 24 and 48 h", "code": "other", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2000040375", "date": "2020-11-28" }, "enrollment": { "start": "2021-01", "end": "2021-04" }, "ethics_approval": true, "planned_n": 80, "country": "China", "centers": "single", "note": "Combined spinal-epidural without GA; esketamine given awake 1 min before incision. Spinal ropivacaine dose-finding (up-down within each group). EPDS at discharge, day not given." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2020, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.3, "pump_only": false, "size": 80, "registration_shared_with": [] }, { "trial": "T025", "source": "abstract", "source_record": "pmid:34633992", "records": [ "pmid:34633992" ], "design": { "id": "T025", "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, "dose_note": "over 40 min; timing relative to surgery not stated", "start": "unclear", "end": "unclear" }, { "name": "Normal saline", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "elective supratentorial brain tumor resection", "depression_selection": "selected", "selection_criterion": "moderate-to-severe depressive symptoms", "age_group": null, "depression_measures": [ { "measure": "Montgomery-Asberg Depression Rating Scale", "code": "MADRS", "days": [ 3 ], "primary": true } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "The abstract does not say when the 40-min infusion was given (before, during or after surgery) or under what anesthesia, so conscious dosing is unclear." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T026", "source": "fulltext", "source_record": "pmid:33859685", "records": [ "pmid:33859685" ], "design": { "id": "T026", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group C", "role": "control" }, { "name": "Group K", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.4, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 50 mL over 20 min from after the spinal block, continued whether or not the procedure had ended", "start": "after_induction", "end": "unclear" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "dilation and curettage for incomplete or retained abortion", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Profile of Mood States (POMS)", "code": "POMS_D", "days": [ 0 ], "primary": true } ], "pain_measures": [], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "PACTR", "id": "PACTR201907779292947", "date": "2019-07-16" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 60, "country": "Egypt", "centers": "single", "note": "Spinal anesthesia with midazolam premedication; infusion given awake. POMS (which has a depression subscale) before and 2 h after surgery; primary outcome is POMS mood change." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 60, "registration_shared_with": [] }, { "trial": "T027", "source": "fulltext", "source_record": "pmid:33767791", "records": [ "pmid:33767791" ], "design": { "id": "T027", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Intervention group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "with thiopental 1-2 mg/kg at induction (control thiopental 3-5 mg/kg)", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "cesarean", "procedure": "caesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 14, 28 ], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 70, "country": "Iran", "centers": "multi", "note": "Ketamine with a reduced thiopental dose at induction of GA vs thiopental alone at a higher dose. Single induction dose; cesarean length not stated, late false as the only dose was at induction." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 70, "registration_shared_with": [] }, { "trial": "T028", "source": "abstract", "source_record": "pmid:31948296", "records": [ "pmid:31948296" ], "design": { "id": "T028", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control group (normal saline)", "role": "control" }, { "name": "Racemic ketamine group", "role": "ketamine", "drug": "ketamine", "route": null, "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "pretreatment; dose, route and timing not stated", "start": "unclear", "end": "unclear" }, { "name": "S-ketamine group", "role": "ketamine", "drug": "esketamine", "route": null, "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "pretreatment; dose, route and timing not stated", "start": "unclear", "end": "unclear" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "breast cancer surgery", "depression_selection": "selected", "selection_criterion": "mild/moderate depression", "age_group": null, "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 3, 7, 30, 90 ], "primary": false } ], "pain_measures": [ { "measure": "VAS", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2017-06", "end": "2018-06" }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Abstract gives no dose, route or timing beyond 'pretreatment', and no anesthesia, so conscious dosing is unclear." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "mixed", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T029", "source": "fulltext", "source_record": "pmid:36769799", "records": [ "pmid:36769799", "ppr:PPR538081" ], "design": { "id": "T029", "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": 0.12, "infusion_hours": null, "pump": false, "dose_note": "bolus during induction (after midazolam, before sufentanil and propofol); infusion 'for more than 30 min'", "start": "at_induction", "end": "unclear" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "surgery for Crohn's disease", "depression_selection": "selected", "selection_criterion": "HAMD 8-24", "age_group": "adult", "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 1, 3, 7, 30 ], "primary": true }, { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 3, 7, 30 ], "primary": false } ], "pain_measures": [ { "measure": "NRS", "code": "other", "days": [ 1, 2, 7 ], "primary": false }, { "measure": "opioid use during hospital stay (morphine equivalents)", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT05506787", "date": null }, "enrollment": { "start": "2020-09-01", "end": "2022-03-01" }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "Described as intraoperative use under GA, bolus with induction. The infusion ran 'more than 30 min' and when it stopped relative to the end of surgery is not stated, so late null." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": { "first_submitted": "2022-08-14", "start": "2020-09-01" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 120, "registration_shared_with": [] }, { "trial": "T030", "source": "fulltext", "source_record": "pmid:36683972", "records": [ "pmid:36683972" ], "design": { "id": "T030", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group S (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "5 min after delivery", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Group L (saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 14, 28 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "NRS when coughing", "code": "movement", "days": [ 0, 1, 2 ], "primary": true } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100054332", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Combined spinal-epidural; bolus after delivery while awake." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T031", "source": "fulltext", "source_record": "pmid:36570810", "records": [ "pmid:36570810" ], "design": { "id": "T031", "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": false, "dose_note": "in 100 mL over 40 min from cord clamping; continued in the PACU if unfinished", "start": "after_delivery", "end": "unclear" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean delivery", "depression_selection": "selected", "selection_criterion": "prenatal EPDS >= 10", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 2, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 42 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT03336541", "date": "2017-11-08" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 64, "country": "China", "centers": "single", "note": "Neuraxial anesthesia (GA excluded); infusion given awake and could run into the PACU. EPDS at 48 h is primary, at 42 days secondary." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2017, "registry_dates": { "first_submitted": "2017-11-06", "start": "2017-11-23" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 64, "registration_shared_with": [] }, { "trial": "T032", "source": "fulltext", "source_record": "pmid:36454569", "records": [ "pmid:36454569" ], "design": { "id": "T032", "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": null, "pump": false, "dose_note": "when the infusion started and stopped is not stated", "start": "unclear", "end": "unclear" }, { "name": "Saline", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "gynecological laparoscopic surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS depression subscale (HADS-D)", "code": "HADS_D", "days": [ 1, 3 ], "primary": false } ], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 1, 2 ], "primary": false }, { "measure": "VAS on movement", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "hydromorphone consumption at 24 and 48 h", "code": "opioid", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2021-08", "end": "2022-04" }, "ethics_approval": true, "planned_n": 184, "country": "China", "centers": "single", "note": "Infusion rate given but not when it started or stopped relative to induction and the end of surgery, so conscious dosing unclear. Primary outcome is sleep disturbance." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 184, "registration_shared_with": [] }, { "trial": "T033", "source": "fulltext", "source_record": "pmid:36451452", "records": [ "pmid:36451452" ], "design": { "id": "T033", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group L (low dose)", "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": "0.1 mg/kg added to 150 mL sufentanil PCIA (5 mL load, 2 mL/h, 1 mL bolus, 15 min lockout), 48 h", "start": "end_of_surgery", "end": "after_emergence" }, { "name": "Group M (middle dose)", "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": "0.2 mg/kg added to 150 mL sufentanil PCIA, 48 h", "start": "end_of_surgery", "end": "after_emergence" }, { "name": "Group H (high dose)", "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": "0.4 mg/kg added to 150 mL sufentanil PCIA, 48 h", "start": "end_of_surgery", "end": "after_emergence" }, { "name": "Group C (control)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under combined spinal-epidural anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "code": "EPDS", "days": [ 7, 42 ], "primary": false } ], "pain_measures": [ { "measure": "effective PCIA presses within 48 h", "code": "other", "days": [ 2 ], "primary": true }, { "measure": "total sufentanil consumption within 48 h", "code": "opioid", "days": [ 2 ], "primary": true }, { "measure": "rescue tramadol within 48 h", "code": "opioid", "days": [ 2 ], "primary": true } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200060387", "date": "2021-04-07" }, "enrollment": { "start": "2021-05-02", "end": "2021-12-31" }, "ethics_approval": true, "planned_n": 240, "country": "China", "centers": "single", "note": "Esketamine only in the postoperative PCIA, connected at skin suture; all women under CSE (the participants paragraph says 'general anesthesia', contradicted by the anesthesia description and exclusions). Drug named as esketamine only in the sample-size section. EPDS not the named primary (presses, sufentanil, rescue) although the sample size was powered on PPD at 6 weeks. planned_n: 60 per group x 4 per the sample-size section, but 160 enrolled and 160 envelopes. Same registry ID as T044 and T052." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 240, "registration_shared_with": [ "T044", "T052" ] }, { "trial": "T034", "source": "fulltext", "source_record": "pmid:36271352", "records": [ "pmid:36271352" ], "design": { "id": "T034", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "SC group", "role": "ketamine", "drug": "ketamine", "route": "other", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "subcutaneous injection (plus IV saline), shortly after delivery", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "IV group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single dose infused over 40 min (plus SC saline), shortly after delivery", "start": "after_delivery", "end": "unclear" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery under spinal anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postpartum Depression Scale (EPDS)", "code": "EPDS", "days": [ 1, 2, 21, 42 ], "primary": true } ], "pain_measures": [ { "measure": "maximum intraoperative pain (NRS)", "code": "other", "days": [ 0 ], "primary": false }, { "measure": "surgical site pain NRS", "code": "other", "days": [ 1, 2, 21, 42 ], "primary": false }, { "measure": "opioid consumption first 48 h (oral MME)", "code": "opioid", "days": [ 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT04227704", "date": "2020-01-14" }, "enrollment": { "start": "2020-12", "end": "2021-08" }, "ethics_approval": true, "planned_n": 60, "country": "USA", "centers": "single", "note": "All doses while awake under spinal, shortly after delivery. SC route coded other. Whether the 40-min IV infusion ended before the end of surgery is not stated. EPDS-based 6-week PPD prevalence is among the primary (feasibility) outcomes." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2019, "registry_dates": { "first_submitted": "2019-11-20", "start": "2020-11-12" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 60, "registration_shared_with": [] }, { "trial": "T035", "source": "library", "source_record": "pmid:35613989", "records": [ "pmid:35613989" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 80, "registration_shared_with": [] }, { "trial": "T036", "source": "fulltext", "source_record": "pmid:35479322", "records": [ "pmid:35479322" ], "design": { "id": "T036", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "K1 group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.1, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single bolus 5 min before skin incision", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "K2 group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single bolus 5 min before skin incision", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "K3 group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single bolus 5 min before skin incision", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "C group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective open colorectal cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS depression subscale (HAD-D)", "code": "HADS_D", "days": [ 1, 2, 3 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain 30 min after extubation", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2015-01", "end": "2017-10" }, "ethics_approval": true, "planned_n": 104, "country": "China", "centers": "single", "note": "Single bolus 5 min before skin incision, described after GA induction and intubation (the first mention says '5 min before operation'); open surgery under 4 h with incision >10 cm, so the dose was well before the last 30 min. PCIA had no ketamine." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.2, "pump_only": false, "size": 104, "registration_shared_with": [] }, { "trial": "T037", "source": "registry", "source_record": "nct:NCT05229653", "records": [ "nct:NCT05229653" ], "design": { "id": "T037", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Low-Dose Ketamine (LDK) Treatment Group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.6, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single dose over at least 30 min in PACU", "start": "after_emergence", "end": "after_emergence" }, { "name": "Control Group", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "robotic endometriosis excision surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Montgomery-Asberg Depression Rating Scale (MADRS)", "code": "MADRS", "days": [ 1, 27, 55, 83 ], "primary": false } ], "pain_measures": [ { "measure": "pelvic pain VAS", "code": "other", "days": [ 1, 27, 55, 83 ], "primary": true }, { "measure": "change in opioid use", "code": "opioid", "days": [ 83 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": false }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT05229653", "date": "2022-01-18" }, "enrollment": { "start": "2022-04-12", "end": null }, "ethics_approval": false, "planned_n": null, "country": "USA", "centers": null, "note": "Registry record; terminated with actual enrollment of 1. Ketamine given in PACU once stable and awake. Anesthesia type not stated. Only the participant masked. Country inferred from NYULH. Chronic pelvic pain population, not depression-selected." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": { "first_submitted": "2022-01-18", "start": "2022-04-12" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.6, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T038", "source": "registry", "source_record": "nct:NCT04220489", "records": [ "nct:NCT04220489" ], "design": { "id": "T038", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine Group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 1.0, "infusion_mg_per_kg_h": 0.2, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "bolus 15 min after GA induction, then 0.2 mg/kg/h (max 20 mg/h) through surgery until 48 h after fascial closure", "start": "after_induction", "end": "after_emergence" }, { "name": "Placebo Group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "lumbar, thoracic or cervical spine surgery in opioid-dependent patients", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PROMIS Emotional Distress-Depression Short Form", "code": "OTHER", "days": [ 10, 42 ], "primary": false } ], "pain_measures": [ { "measure": "hydromorphone PCA use, first 72 h", "code": "opioid", "days": [ 3 ], "primary": true }, { "measure": "VAS pain (best/worst), averaged over 72 h", "code": "other", "days": [ 0, 1, 2, 3 ], "primary": true }, { "measure": "opioid use from medical record", "code": "opioid", "days": [ 3, 42 ], "primary": true }, { "measure": "Pain Catastrophizing Scale", "code": "other", "days": [ 10, 42 ], "primary": false }, { "measure": "cold-pressor pain threshold/tolerance", "code": "other", "days": [ 42 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": false }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT04220489", "date": "2019-11-21" }, "enrollment": { "start": "2019-12-17", "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Registry record; terminated with actual enrollment of 1. Infusion continued 48 h after surgery (coded pump), so dosing while awake. PROMIS depression at the POD 10-14 visit and 6 weeks. Masked: participant, care provider, investigator (not outcomes assessor). Ages not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2019, "registry_dates": { "first_submitted": "2019-11-21", "start": "2019-12-17" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T039", "source": "fulltext", "source_record": "pmid:41797793", "records": [ "pmid:41797793", "ppr:PPR688218" ], "design": { "id": "T039", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control Group (Group C): no labor analgesia", "role": "other" }, { "name": "Experimental Group A: labor analgesia with esketamine", "role": "ketamine", "drug": "esketamine", "route": "epidural", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "0.5 mg/kg added to 100 mL epidural solution; background 2 mL/h + PIEB 8 mL hourly + PCEA, until delivery", "start": "during_labor", "end": "end_of_surgery" }, { "name": "Experimental Group B: labor analgesia alone", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "epidural labor analgesia for spontaneous vaginal delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 1, 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain during labor and postpartum", "code": "other", "days": [ 0, 1, 2, 7 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": false, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2500104037", "date": null }, "enrollment": { "start": "2020-02", "end": "2022-01" }, "ethics_approval": true, "planned_n": 330, "country": "China", "centers": "single", "note": "Esketamine in the epidural labor pump, awake, until delivery (end coded end_of_surgery = end of delivery). Group B taken as the inert control, though its pump program as written differs (PCEA with optional 4 mL/h vs 2 mL/h + PIEB); Group C had no epidural and is coded other. Open-label; assessors only described as not involved in intrapartum care. Registered retrospectively. Per-protocol, excluding cesarean conversions." }, "decided_by": "both coders", "notices": [], "design_conflict": true, "registration_year": 2025, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 330, "registration_shared_with": [] }, { "trial": "T040", "source": "fulltext", "source_record": "pmid:38188539", "records": [ "pmid:38188539", "pmid:40185412", "pmid:37205558", "pmid:39399033", "ppr:PPR653331", "ppr:PPR915323" ], "design": { "id": "T040", "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": false, "dose_note": "single dose in 40 mL saline infused over 40 min", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (saline) group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "elective non-cardiac, non-intracranial surgery", "depression_selection": "selected", "selection_criterion": "MDD (MINI) with PHQ-8 >=12 and MADRS + HADS >=31", "age_group": "adult", "depression_measures": [ { "measure": "MADRS", "code": "MADRS", "days": [ 1, 2, 3, 5, 7, 14 ], "primary": true }, { "measure": "HADS score", "code": "HADS_TOTAL", "days": [], "primary": false } ], "pain_measures": [ { "measure": "BPI-SF postoperative pain", "code": "other", "days": [], "primary": false }, { "measure": "cumulative and daily opioid use (MME)", "code": "opioid", "days": [ 1, 2, 3, 5, 7, 14 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 40, "country": "USA", "centers": "single", "note": "Infusion started after induction and incision during maintenance GA (PSI 25-50) to keep participants masked. Surgeries were heterogeneous and durations not given, so whether the 40-min infusion ended within the last 30 min is unclear. MADRS primary on days 1-3, exploratory on 5, 7, 14. HADS days not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 40, "registration_shared_with": [] }, { "trial": "T041", "source": "fulltext", "source_record": "pmid:39432604", "records": [ "pmid:39432604", "ppr:PPR737597" ], "design": { "id": "T041", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E", "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 10 min after induction, plus 2 mg/kg in 100 mL sufentanil PCIA over 48 h", "start": "after_induction", "end": "after_emergence" }, { "name": "Group C", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "older patients' cancer surgery (orthopedic, urologic, major abdominal)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "Hamilton Depression Scale 17 (HAMD-17)", "code": "HAMD", "days": [], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300069249", "date": null }, "enrollment": { "start": "2022-08-01", "end": "2023-08-30" }, "ethics_approval": true, "planned_n": 210, "country": "China", "centers": "single", "note": "Bolus under GA plus esketamine in the 48-h postoperative PCIA, so dosing while awake; PCIA start time not stated. HAMD-17 days not stated (secondary: postoperative depressive symptoms). Primary outcomes delirium and POCD. Participants coded blinded since assignments were not announced until discharge." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 1.0, "pump_only": false, "size": 210, "registration_shared_with": [] }, { "trial": "T042", "source": "fulltext", "source_record": "pmid:38321436", "records": [ "pmid:38321436", "ppr:PPR754583" ], "design": { "id": "T042", "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": "1.5 mg/kg in 100 mL sufentanil PCIA (2 mL/h + 1 mL bolus), from skin closure for 2 days", "start": "end_of_surgery", "end": "after_emergence" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "NRS on movement", "code": "movement", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "cumulative sufentanil consumption 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": "ChiCTR2200067054", "date": "2022-12-26" }, "enrollment": { "start": "2023-01-01", "end": "2023-09" }, "ethics_approval": true, "planned_n": 246, "country": "China", "centers": "single", "note": "Esketamine only in the PCIA, started after skin closure under spinal anesthesia, so all dosing while awake. Enrollment end stated as 'September 31, 2023'. TAP block given to all." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 246, "registration_shared_with": [] }, { "trial": "T043", "source": "fulltext", "source_record": "pmid:38200438", "records": [ "pmid:38200438", "ppr:PPR757766" ], "design": { "id": "T043", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "0.2 mg/kg in 20 mL pumped over 40 min from the start of the operation; route not named, presumably IV", "start": "after_induction", "end": "unclear" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section under combined spinal-epidural anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Depression Scale (EPDS)", "code": "EPDS", "days": [ 4, 42 ], "primary": true } ], "pain_measures": [ { "measure": "pain NRS", "code": "other", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100053422", "date": "2021-11-20" }, "enrollment": { "start": "2020-07-01", "end": "2023-07-21" }, "ethics_approval": true, "planned_n": 346, "country": "China", "centers": "single", "note": "Started at the beginning of the cesarean under CSE (start coded after_induction = after the block), awake; end relative to end of surgery not stated. No primary named; EPDS taken as primary since the sample size is powered on PPD. SDS >=50 excluded." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 346, "registration_shared_with": [] }, { "trial": "T044", "source": "fulltext", "source_record": "pmid:37996953", "records": [ "pmid:37996953", "pmid:38166663", "ppr:PPR684652" ], "design": { "id": "T044", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single IV injection right after fetal delivery", "start": "after_delivery", "end": "end_of_surgery" }, { "name": "Group C", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "epidural labor analgesia for vaginal delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (with diagnostic criteria)", "code": "EPDS", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200060387", "date": "2022-05-30" }, "enrollment": { "start": "2022-06-01", "end": "2023-02-28" }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "Single dose while awake under epidural labor analgesia, right after fetal delivery (end coded end_of_surgery = end of delivery). Same registry ID as T033 and T052." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 120, "registration_shared_with": [ "T033", "T052" ] }, { "trial": "T045", "source": "fulltext", "source_record": "pmid:37482224", "records": [ "pmid:37482224" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 150, "registration_shared_with": [] }, { "trial": "T046", "source": "library", "source_record": "pmid:37442447", "records": [ "pmid:37442447" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 300, "registration_shared_with": [] }, { "trial": "T047", "source": "fulltext", "source_record": "pmid:37424809", "records": [ "pmid:37424809" ], "design": { "id": "T047", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.1, "infusion_mg_per_kg_h": 0.1, "infusion_hours": null, "pump": false, "dose_note": "bolus after induction drugs, before intubation; infusion until end of surgery", "start": "at_induction", "end": "end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "laparoscopic radical resection for colorectal cancer", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [], "pain_measures": [ { "measure": "NRS pain", "code": "other", "days": [ 1, 2, 3, 7 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200056278", "date": null }, "enrollment": { "start": "2022-07", "end": "2022-10" }, "ethics_approval": true, "planned_n": 64, "country": "China", "centers": "single", "note": "Mood measured only with PANAS (positive and negative affect), not a depression scale; primary was fatigue (ICFS). Infusion ran to the end of surgery under GA with TAP block." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 64, "registration_shared_with": [] }, { "trial": "T048", "source": "library", "source_record": "pmid:37192228", "records": [ "pmid:37192228" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.6, "pump_only": false, "size": 120, "registration_shared_with": [] }, { "trial": "T049", "source": "fulltext", "source_record": "pmid:37009103", "records": [ "pmid:37009103" ], "design": { "id": "T049", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.1, "infusion_mg_per_kg_h": 0.1, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "bolus ~3 min before incision, infusion to end of surgery, then 1 mg/kg in 100 mL sufentanil PCIA for 48 h (~0.015 mg/kg/h)", "start": "after_induction", "end": "after_emergence" }, { "name": "Normal saline group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "thoracoscopic lung cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Beck Depression Inventory-II (BDI-II)", "code": "BDI", "days": [ 2, 30, 90 ], "primary": true } ], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 1, 2 ], "primary": false }, { "measure": "VAS on coughing", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "PCIA sufentanil consumption 0-24 and 0-48 h", "code": "opioid", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": null, "date": "2021-05-09" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 156, "country": "China", "centers": "single", "note": "Intraoperative infusion to end of surgery plus esketamine PCIA for 48 h, so dosing while awake. BDI-II also at discharge; primary is depressive symptoms at 1 month. Registry ID not given." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 156, "registration_shared_with": [] }, { "trial": "T050", "source": "fulltext", "source_record": "pmid:36942305", "records": [ "pmid:36942305" ], "design": { "id": "T050", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine group", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.6, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single dose over ~45 min in PACU", "start": "after_emergence", "end": "after_emergence" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "mastectomy with immediate reconstruction", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Patient Health Questionnaire-2 (PHQ-2)", "code": "PHQ9", "days": [], "primary": false } ], "pain_measures": [ { "measure": "BPI pain severity subscale", "code": "other", "days": [ 0, 1, 2, 7 ], "primary": true }, { "measure": "Breast Cancer Pain Questionnaire", "code": "other", "days": [], "primary": false }, { "measure": "opioid usage", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT04831736", "date": "2021-05-04" }, "enrollment": { "start": "2021-04", "end": "2022-04" }, "ethics_approval": true, "planned_n": null, "country": "USA", "centers": "single", "note": "Single dose after GA, in PACU once medically stable. PHQ-2 timing given only in a figure. Registration 'first posted 05/04/2021' read as month/day. Pilot, not powered." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": { "first_submitted": "2021-04-01", "start": "2021-04-26" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.6, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T051", "source": "library", "source_record": "pmid:36863473", "records": [ "pmid:36863473" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.6, "pump_only": false, "size": 105, "registration_shared_with": [] }, { "trial": "T052", "source": "fulltext", "source_record": "pmid:36862862", "records": [ "pmid:36862862" ], "design": { "id": "T052", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 100 mL saline within 10 min after the infant was delivered", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Group C", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS screen (>9)", "code": "EPDS", "days": [ 7, 42 ], "primary": true }, { "measure": "DSM-IV clinical interview for PPD", "code": "OTHER", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200060387", "date": "2022-05-30" }, "enrollment": { "start": "2022-04-01", "end": "2022-11-30" }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "Single dose while awake under CSE after delivery. No primary named; PPD at 1 and 6 weeks taken as primary since the sample size is powered on it. Same registry ID as T033 and T044." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 120, "registration_shared_with": [ "T033", "T044" ] }, { "trial": "T053", "source": "fulltext", "source_record": "pmid:40696459", "records": [ "pmid:40696459", "ppr:PPR956640" ], "design": { "id": "T053", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group S", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single dose given with the induction drugs (first, then propofol bolus)", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group P", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "laparoscopic total hysterectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Hamilton Depression Scale (HAMD)", "code": "HAMD", "days": [ 3, 7, 30 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain", "code": "other", "days": [ 0, 1, 2, 3, 7, 30 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100049857", "date": null }, "enrollment": { "start": "2022-04", "end": "2022-07" }, "ethics_approval": true, "planned_n": 118, "country": "China", "centers": "single", "note": "Esketamine given as part of the induction sequence (control got a saline bolus 'followed by' propofol 2 mg/kg), so coded at_induction/none; it was injected just before the propofol bolus. Single dose, no later dosing, so not late. Primary QoR-40. Single-blind; who was masked is garbled." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 118, "registration_shared_with": [] }, { "trial": "T054", "source": "fulltext", "source_record": "pmid:41929413", "records": [ "pmid:41929413" ], "design": { "id": "T054", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group S (esketamine + butorphanol)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.15, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "intraoperative infusion until end of surgery, then 2 mg/kg in 150 mL butorphanol PCIA", "start": "unclear", "end": "after_emergence" }, { "name": "Group C (butorphanol)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 0, 1, 4, 7 ], "primary": false } ], "pain_measures": [ { "measure": "PCIA presses in 24 h", "code": "other", "days": [ 1 ], "primary": true }, { "measure": "VAS", "code": "other", "days": [ 0, 1, 2, 4 ], "primary": false }, { "measure": "rescue analgesia (diclofenac)", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100054435", "date": "2021-12-27" }, "enrollment": { "start": "2022-01", "end": "2022-08" }, "ethics_approval": true, "planned_n": 160, "country": "China", "centers": "single", "note": "Under CSE, awake; infusion start not stated (before or after delivery), PCIA esketamine afterwards. Control got 5% glucose and butorphanol PCIA." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [ "T072" ], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 160, "registration_shared_with": [] }, { "trial": "T055", "source": "fulltext", "source_record": "pmid:39496041", "records": [ "pmid:39496041" ], "design": { "id": "T055", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "S group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "within 10 min after cord clamping", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "C group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 3, 7, 14 ], "primary": true } ], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "VAS on movement", "code": "movement", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "effective PCIA presses at 48 h", "code": "other", "days": [ 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400080884", "date": "2024-02-15" }, "enrollment": { "start": "2024-02-16", "end": "2024-04-30" }, "ethics_approval": true, "planned_n": 150, "country": "China", "centers": "multi", "note": "Single dose while awake under CSE after cord clamping. Two hospitals." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 150, "registration_shared_with": [] }, { "trial": "T056", "source": "fulltext", "source_record": "pmid:39416617", "records": [ "pmid:39416617" ], "design": { "id": "T056", "eligible": false, "exclusion_reason": "not_randomized", "timing_comparison": false, "arms": [ { "name": "Study group", "role": "ketamine", "drug": "esketamine", "route": "epidural", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "1 mg/kg with sufentanil 2 ug/kg in 100 mL epidural (6 mL/h, 7 mL PCEA, 30 min lockout)", "start": "during_labor", "end": "unclear" }, { "name": "Control group", "role": "other" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "epidural labor analgesia for vaginal delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Self-rating Depression Scale (SDS)", "code": "SDS", "days": [], "primary": false } ], "pain_measures": [ { "measure": "VAS during analgesia and after delivery", "code": "other", "days": [ 0 ], "primary": false }, { "measure": "analgesic effect grade", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": "2021-07-10", "end": "2022-05-10" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Described as a retrospective study of records (ethics approved in 2023, after the data period) whose groups were 'divided randomly'; not a randomized allocation. Control epidural had sufentanil 3 ug/kg vs 2 ug/kg with esketamine, so coded other (would also fail the inert-control rule). SDS 'after delivery', day not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T057", "source": "fulltext", "source_record": "pmid:39371565", "records": [ "pmid:39371565" ], "design": { "id": "T057", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Low-dose group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.15, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 10 mL after fetal delivery", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "High-dose group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 10 mL after fetal delivery", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 2, 7, 42 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "rescue acetaminophen", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": "2021-01", "end": "2023-01" }, "ethics_approval": true, "planned_n": null, "country": null, "centers": null, "note": "Single dose while awake under CSE after delivery. Only the administering anesthesiologists are said to be blinded. EPDS >=13 excluded. No registration or country stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T058", "source": "fulltext", "source_record": "pmid:39342105", "records": [ "pmid:39342105" ], "design": { "id": "T058", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group S", "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": "0.5 mg/kg with sufentanil 2 ug/kg in 100 mL PCIA for 48 h", "start": "postoperative", "end": "after_emergence" }, { "name": "Group C", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "hip fracture surgery in older patients", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "Geriatric Depression Scale (GDS-15)", "code": "GDS", "days": [ 2, 7, 30 ], "primary": true } ], "pain_measures": [ { "measure": "worst pain VAS", "code": "other", "days": [], "primary": false }, { "measure": "effective PCIA presses", "code": "other", "days": [], "primary": false }, { "measure": "sufentanil consumption", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200061956", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 90, "country": "China", "centers": "single", "note": "Esketamine only in the postoperative PCIA, after CSE plus fascia iliaca block; all dosing while awake." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": true, "size": 90, "registration_shared_with": [] }, { "trial": "T059", "source": "fulltext", "source_record": "pmid:39317541", "records": [ "pmid:39317541" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2020, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 1.0, "pump_only": false, "size": 60, "registration_shared_with": [] }, { "trial": "T060", "source": "fulltext", "source_record": "pmid:39275772", "records": [ "pmid:39275772" ], "design": { "id": "T060", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Morning operation with esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single injection before induction, immediately followed by propofol via pump at 240 mL/h", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Morning operation with saline", "role": "control" }, { "name": "Afternoon operation with esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single injection before induction, immediately followed by propofol via pump at 240 mL/h", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Afternoon operation with saline", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": false, "setting": "surgery", "procedure": "scheduled surgery under GA in older patients (anesthesia <=4 h)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "Hospital Anxiety and Depression Scale (HAD)", "code": "HADS_TOTAL", "days": [ 1, 3, 7 ], "primary": false } ], "pain_measures": [ { "measure": "postoperative NRS", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2022-01-04", "end": "2023-03-07" }, "ethics_approval": true, "planned_n": 432, "country": "China", "centers": "single", "note": "2x2 factorial (morning/afternoon x esketamine/saline). Esketamine injected after preoxygenation 'before induction', then propofol by pump at 240 mL/h to BIS <60, so participants were briefly awake after the dose: coded before_induction/some. Single dose, not late. HAD subscales not specified." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 432, "registration_shared_with": [] }, { "trial": "T061", "source": "fulltext", "source_record": "pmid:39185082", "records": [ "pmid:39185082" ], "design": { "id": "T061", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.15, "infusion_hours": null, "pump": false, "dose_note": "0.3 mg/kg/h from start of sedation, 0.15 mg/kg/h after tumescent injection, stopped 30 min before end of surgery", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group C", "role": "control" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "liposuction under tumescent local anesthesia with IV sedation", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS depression subscale (HADS-D)", "code": "HADS_D", "days": [ 3 ], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400080363", "date": null }, "enrollment": { "start": "2023-12-30", "end": "2024-03-30" }, "ethics_approval": true, "planned_n": 169, "country": "China", "centers": "single", "note": "Sedation with spontaneous breathing (MOAA/S ~3, BIS 60-80, nasal oxygen); infusion ran from start of sedation (start coded at_induction of sedation) to 30 min before end of surgery. Primary was satisfaction." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 169, "registration_shared_with": [] }, { "trial": "T062", "source": "library", "source_record": "pmid:38918160", "records": [ "pmid:38918160" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 72, "registration_shared_with": [] }, { "trial": "T063", "source": "fulltext", "source_record": "pmid:38808490", "records": [ "pmid:38808490" ], "design": { "id": "T063", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "in 20 mL infused over 40 min (30 mL/h) after cord clamping", "start": "after_delivery", "end": "unclear" }, { "name": "Placebo (saline) group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "childbirth, vaginal or cesarean", "depression_selection": "selected", "selection_criterion": "EPDS >=10 at admission for delivery", "age_group": "adult", "depression_measures": [ { "measure": "MINI 6.0.0 depression module (major depressive episode)", "code": "OTHER", "days": [ 42 ], "primary": true }, { "measure": "EPDS", "code": "EPDS", "days": [ 7, 42 ], "primary": false }, { "measure": "HAMD-17", "code": "HAMD", "days": [ 42 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain", "code": "other", "days": [ 1, 7, 42 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 364, "country": "China", "centers": "multi", "note": "Infused while awake after cord clamping: vaginal births with or without epidural (others IM pethidine), cesareans under CSE or epidural; no GA. Setting includes both vaginal and cesarean births. Five centers. No registration stated in the Methods." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 364, "registration_shared_with": [] }, { "trial": "T064", "source": "fulltext", "source_record": "pmid:38710325", "records": [ "pmid:38710325" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2016, "registry_dates": { "first_submitted": "2016-07-31", "start": "2017-03-20" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 274, "registration_shared_with": [] }, { "trial": "T065", "source": "fulltext", "source_record": "pmid:38658886", "records": [ "pmid:38658886" ], "design": { "id": "T065", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group (Group E)", "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 0.2 mg/kg IV infusion after induction", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Control group (Group C)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "unilateral modified radical mastectomy for breast cancer", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 3, 7, 30 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain score", "code": "other", "days": [ 1, 3, 7, 30 ], "primary": false }, { "measure": "intraoperative remifentanil dosage", "code": "opioid", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2022-05", "end": "2023-03" }, "ethics_approval": false, "planned_n": 64, "country": "China", "centers": "single", "note": "Single dose right after induction for a mastectomy, so none and late false. Psychotomimetic true on postoperative delirium only. Assessors: research staff not told the allocation. No ethics approval or registration stated in the text." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 64, "registration_shared_with": [] }, { "trial": "T066", "source": "fulltext", "source_record": "pmid:38586266", "records": [ "pmid:38586266" ], "design": { "id": "T066", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Lidocaine group (Group L)", "role": "other", "dose_note": "IV lidocaine 1.5 mg/kg before induction, then 1.5 mg/kg/h" }, { "name": "Esketamine group (Group E)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": 0.25, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "bolus 10 min before induction; infusion until the end of skin closure", "start": "before_induction", "end": "end_of_surgery" }, { "name": "Normal saline placebo group (Group C)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "thyroidectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Self-Rating Depression Scale (SDS)", "code": "SDS", "days": [ 2 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain (1, 2, 6, 12, 24, 48 h after surgery)", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "perioperative opioid use", "code": "opioid", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100043935", "date": "2021-03-05" }, "enrollment": { "start": "2021-04", "end": "2022-05" }, "ethics_approval": true, "planned_n": 135, "country": "China", "centers": "single", "note": "Bolus 10 min before induction, while awake, so some; infusion ran to the end of skin closure (late true). Only anesthesiologist and patient named as blinded. Primary outcome QoR-40." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 135, "registration_shared_with": [] }, { "trial": "T067", "source": "fulltext", "source_record": "pmid:38522144", "records": [ "pmid:38522144" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.7, "pump_only": false, "size": 135, "registration_shared_with": [] }, { "trial": "T068", "source": "library", "source_record": "pmid:38497863", "records": [ "pmid:38497863" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T069", "source": "fulltext", "source_record": "pmid:38446480", "records": [ "pmid:38446480" ], "design": { "id": "T069", "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": 50, "dose_note": "0.25 mg/kg with midazolam 2 mg right after delivery; PCIA esketamine 50 mg + sufentanil 100 ug in 100 mL, 2 mL/h background for 48 h, 2 mL bolus, 10 min lockout", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 7, 14, 28, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS pain at rest (12, 24, 48, 72 h)", "code": "rest", "days": [ 0, 1, 2, 3 ], "primary": false }, { "measure": "NRS pain during movement (12, 24, 48, 72 h)", "code": "movement", "days": [ 0, 1, 2, 3 ], "primary": false }, { "measure": "postpartum pain sensitivity", "code": "other", "days": [ 7 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100054199", "date": null }, "enrollment": { "start": "2022-01-01", "end": "2023-01-01" }, "ethics_approval": true, "planned_n": 300, "country": "China", "centers": "single", "note": "Combined spinal-epidural, awake; bolus after delivery plus esketamine PCIA, so some. Both arms got midazolam 2 mg. Planned 150 per arm (128 calculated). Fujian Provincial Hospital and its southern branch, coded single." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 300, "registration_shared_with": [] }, { "trial": "T070", "source": "fulltext", "source_record": "pmid:38322862", "records": [ "pmid:38322862", "agr:IND608566629" ], "design": { "id": "T070", "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": 24, "pump": true, "pump_total_mg": null, "dose_note": "only in a 24 h postoperative continuous IV analgesia pump with sufentanil 0.1 ug/kg/h; esketamine rate printed as 0.05 mcg/kg/h (0.75 mcg/mL), probably mg", "start": "postoperative", "end": "after_emergence" }, { "name": "Control group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "elective VATS lung resection", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 2 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain score", "code": "other", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": null, "date": null }, "enrollment": { "start": "2022-07-07", "end": "2023-02-20" }, "ethics_approval": true, "planned_n": 80, "country": null, "centers": "single", "note": "Esketamine only in the pump started after surgery and the erector spinae block, run 24 h, so some; control pump sufentanil alone at the same rate. Primary outcome low minute ventilation. Country and registry ID not given." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": true, "size": 80, "registration_shared_with": [] }, { "trial": "T071", "source": "fulltext", "source_record": "pmid:38179107", "records": [ "pmid:38179107" ], "design": { "id": "T071", "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": 0.3, "infusion_hours": 3, "pump": false, "pump_total_mg": null, "dose_note": "bolus over 10 min then infusion; 8 h in ICU before the August 2022 protocol revision", "start": "after_emergence", "end": "after_emergence" }, { "name": "Normal saline placebo", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "major non-ambulatory surgery (mainly neurosurgery, vascular, cardiac)", "depression_selection": "selected", "selection_criterion": "history of depression (EHR diagnosis or home antidepressant)", "age_group": "adult", "depression_measures": [ { "measure": "MADRS", "code": "MADRS", "days": [ 1, 2, 4, 7, 14 ], "primary": false } ], "pain_measures": [ { "measure": "VAS/NRS pain at rest", "code": "rest", "days": [ 1, 2, 4, 7, 14 ], "primary": false }, { "measure": "VAS/NRS pain on deep breath or coughing", "code": "movement", "days": [ 1, 2, 4, 7, 14 ], "primary": false }, { "measure": "VAS/NRS pain with movement", "code": "movement", "days": [ 1, 2, 4, 7, 14 ], "primary": false }, { "measure": "total opioid dose (oral morphine equivalents) to 07:00 post-infusion day 2", "code": "opioid", "days": [ 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT05233566", "date": "2022-02-10" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 32, "country": "USA", "centers": "single", "note": "Started in the OR immediately after extubation, awake, so some. Feasibility trial: primary outcomes are feasibility; MADRS change to day 4 is the prespecified primary depression measure, so primary false. Days counted from the infusion on the day of surgery. Registration date is first posted." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": { "first_submitted": "2022-02-03", "start": "2022-04-25" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 1.4, "pump_only": false, "size": 32, "registration_shared_with": [] }, { "trial": "T072", "source": "preprint", "source_record": "ppr:PPR829385", "records": [ "ppr:PPR829385" ], "design": { "id": "T072", "eligible": false, "exclusion_reason": "duplicate", "timing_comparison": false, "arms": [ { "name": "Esketamine + butorphanol group (group S)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.15, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "intraoperative infusion 0.15 mg/kg/h; PCIA esketamine 2 mg/kg + butorphanol 0.2 mg/kg in 150 mL (3 mL load, 3 mL/h, 3 mL bolus, 15 min lockout) from the end of surgery", "start": "unclear", "end": "after_emergence" }, { "name": "Butorphanol group (group C)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 0, 1, 4, 7 ], "primary": false } ], "pain_measures": [ { "measure": "analgesic pump presses in 24 h", "code": "opioid", "days": [ 1 ], "primary": true }, { "measure": "VAS pain score", "code": "other", "days": [], "primary": false }, { "measure": "rescue analgesic treatments (diclofenac)", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100054435", "date": "2021-12-27" }, "enrollment": { "start": "2022-01", "end": "2022-08" }, "ethics_approval": true, "planned_n": 160, "country": "China", "centers": "single", "note": "the same trial as T054" }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 160, "registration_shared_with": [], "duplicate_of": "T054" }, { "trial": "T073", "source": "registry", "source_record": "nct:NCT03470675", "records": [ "nct:NCT03470675" ], "design": { "id": "T073", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Epidural saline + IV saline", "role": "other", "dose_note": "double placebo; lacks the epidural morphine the ketamine arm gets" }, { "name": "Epidural morphine 3 mg + IV saline", "role": "control" }, { "name": "Epidural morphine 3 mg + IV ketamine 0.3 mg/kg", "role": "ketamine", "drug": "ketamine", "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 IV infusion with epidural morphine 3 mg; timing not stated", "start": "after_delivery", "end": "unclear" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "vaginal delivery with obstetric anal sphincter injury (OASIS)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (presence of postpartum depression)", "code": "EPDS", "days": [ 7, 42 ], "primary": false }, { "measure": "PROMIS-29 depressive symptoms", "code": "OTHER", "days": [ 90 ], "primary": false } ], "pain_measures": [ { "measure": "perineal pain VRS at 1 week", "code": "other", "days": [ 7 ], "primary": true }, { "measure": "perineal pain VRS at 1 year", "code": "other", "days": [ 365 ], "primary": false }, { "measure": "McGill Pain Questionnaire (perineal pain)", "code": "other", "days": [ 1, 7, 42, 90 ], "primary": false }, { "measure": "Brief Pain Inventory current pain", "code": "other", "days": [ 7, 42, 90 ], "primary": false }, { "measure": "PROMIS-29 pain interference", "code": "other", "days": [ 90 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT03470675", "date": "2018-03-02" }, "enrollment": { "start": "2018-06-27", "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Registry record. Under a functional labor epidural, awake, so some. Morphine + IV saline is the matched inert control; the double-saline arm is coded other. Timing not stated; start after delivery inferred because eligibility needs OASIS diagnosed at delivery. 67 enrolled (actual); registration date is first submitted." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2018, "registry_dates": { "first_submitted": "2018-03-02", "start": "2018-06-27" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.3, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T074", "source": "fulltext", "source_record": "pmid:41576100", "records": [ "pmid:41576100", "ppr:PPR1048069" ], "design": { "id": "T074", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group (group E)", "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 over about 1 min after cord clamping; PCIA esketamine 0.5 mg/kg + sufentanil 4 ug/kg in 200 mL (2 mL/h, 3 mL bolus, 15 min lockout) from the end of surgery", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group (group C)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 2 ], "primary": false } ], "pain_measures": [ { "measure": "maximum NRS pain within 24 h", "code": "other", "days": [ 1 ], "primary": true }, { "measure": "NRS moving incision pain (0-6, 6-12, 12-24 h)", "code": "movement", "days": [ 0, 1 ], "primary": false }, { "measure": "NRS rest incision pain (0-6, 6-12, 12-24 h)", "code": "rest", "days": [ 0, 1 ], "primary": false }, { "measure": "NRS visceral pain (0-6, 6-12, 12-24 h)", "code": "other", "days": [ 0, 1 ], "primary": false }, { "measure": "PCIA presses, rescue analgesic dose, total PCIA consumption", "code": "opioid", "days": [ 0, 1 ], "primary": false }, { "measure": "pressure pain threshold and tolerance (30 min, 24 h)", "code": "other", "days": [ 0, 1 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300078310", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 100, "country": "China", "centers": "single", "note": "Combined spinal-epidural, awake; bolus after cord clamping plus esketamine PCIA, so some. Control: saline and a sufentanil-only PCIA." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 1.0, "pump_only": false, "size": 100, "registration_shared_with": [] }, { "trial": "T075", "source": "fulltext", "source_record": "pmid:41450534", "records": [ "pmid:41450534" ], "design": { "id": "T075", "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": 0.25, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "bolus right after the induction drugs; infusion stopped 15 min before the end of surgery", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Normal saline control group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "elective VATS pulmonary resection", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 3 ], "primary": false } ], "pain_measures": [ { "measure": "moderate-to-severe pain (NRS >= 4 on coughing) on POD1", "code": "movement", "days": [ 1 ], "primary": true }, { "measure": "NRS at rest (4 h, 8 h, POD1, POD3)", "code": "rest", "days": [ 0, 1, 3 ], "primary": false }, { "measure": "NRS during coughing (4 h, 8 h, POD1, POD3)", "code": "movement", "days": [ 0, 1, 3 ], "primary": false }, { "measure": "PCIA volume and hydromorphone consumed", "code": "opioid", "days": [], "primary": false }, { "measure": "intraoperative remifentanil and sufentanil consumption", "code": "opioid", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2500098525", "date": "2025-03-10" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 136, "country": "China", "centers": "single", "note": "All dosing under general anesthesia, from right after the induction drugs to 15 min before the end of surgery, so none; late true because the infusion ran into the last 30 min. Hydromorphone PCIA without esketamine. 136 enrolled to allow dropout (114 calculated)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2025, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 136, "registration_shared_with": [] }, { "trial": "T076", "source": "fulltext", "source_record": "pmid:41422001", "records": [ "pmid:41422001", "ppr:PPR1017694" ], "design": { "id": "T076", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Sufentanil group (S1)", "role": "control" }, { "name": "Sufentanil + 0.25 mg/kg esketamine group (SK1)", "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": "bolus with sufentanil 0.1 ug/kg before incision; PCIA esketamine 1 mg/kg + sufentanil 2 ug/kg in 100 mL (2 mL first dose, 2 mL/h, 1 mL bolus, 10 min lockout), connected 10 min before the end of surgery", "start": "after_induction", "end": "after_emergence" }, { "name": "Sufentanil + 0.5 mg/kg esketamine group (SK2)", "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": "bolus with sufentanil 0.1 ug/kg before incision; PCIA esketamine 1 mg/kg + sufentanil 2 ug/kg in 100 mL (2 mL first dose, 2 mL/h, 1 mL bolus, 10 min lockout), connected 10 min before the end of surgery", "start": "after_induction", "end": "after_emergence" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "laparoscopic total hysterectomy", "depression_selection": "selected", "selection_criterion": "HAM-D 8-20 (diagnosed depression excluded)", "age_group": "adult", "depression_measures": [ { "measure": "HAM-D", "code": "HAMD", "days": [ 1, 2, 5, 7 ], "primary": true } ], "pain_measures": [ { "measure": "VAS (1, 6, 12, 24, 48 h)", "code": "other", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "PCIA button presses over 48 h", "code": "opioid", "days": [ 2 ], "primary": false }, { "measure": "intraoperative analgesic dosage", "code": "opioid", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200065198", "date": "2022-10-31" }, "enrollment": { "start": "2022-11", "end": "2023-12" }, "ethics_approval": true, "planned_n": 135, "country": "China", "centers": "single", "note": "Intraoperative bolus under general anesthesia, but the esketamine PCIA ran after waking, so some. Control got the same sufentanil and no esketamine (no placebo stated). Enrolled HAM-D 8-20, coded selected. Participant blinding not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.75, "pump_only": false, "size": 135, "registration_shared_with": [] }, { "trial": "T077", "source": "fulltext", "source_record": "pmid:41409261", "records": [ "pmid:41409261" ], "design": { "id": "T077", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine (ESK) group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": 0.4, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.2 mg/kg during induction, 0.4 mg/kg/h maintenance until the end of surgery", "start": "at_induction", "end": "end_of_surgery" }, { "name": "Control (CON) group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "elective breast cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Self-Rating Depression Scale (SDS)", "code": "SDS", "days": [ 1, 3 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain score (24, 72 h)", "code": "other", "days": [ 1, 3 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400092257", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 116, "country": "China", "centers": "single", "note": "TIVA; dose during induction and infusion to the end of surgery, so none and late true. Primary outcome postoperative sleep disturbance (PSQI)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 116, "registration_shared_with": [] }, { "trial": "T078", "source": "fulltext", "source_record": "pmid:41328403", "records": [ "pmid:41328403" ], "design": { "id": "T078", "eligible": false, "exclusion_reason": "no_inert_control", "timing_comparison": false, "arms": [ { "name": "Control group", "role": "other", "dose_note": "remimazolam 0.2 mg/kg then fentanyl 1.5 ug/kg" }, { "name": "Study group", "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": "with fentanyl 0.5 ug/kg, 1 min after remimazolam 0.2 mg/kg, before bronchoscopy", "start": "at_induction", "end": "before_end_of_surgery" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "sedation-assisted bronchoscopy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400084672", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 296, "country": "China", "centers": "single", "note": "Control got fentanyl 1.5 ug/kg against 0.5 ug/kg with esketamine and no placebo (opioid substitution), so no inert control. Also no depression measure (QoR-15 only). Sedation with spontaneous breathing." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.6, "pump_only": false, "size": 296, "registration_shared_with": [] }, { "trial": "T079", "source": "fulltext", "source_record": "pmid:41327037", "records": [ "pmid:41327037" ], "design": { "id": "T079", "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": 0.3, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "infusion throughout surgery during maintenance", "start": "after_induction", "end": "end_of_surgery" }, { "name": "Saline control group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "surgery under general anesthesia (type not stated)", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "VAS pain at multiple time points within 72 h", "code": "other", "days": [], "primary": false }, { "measure": "intraoperative remifentanil consumption", "code": "opioid", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": 166, "country": null, "centers": null, "note": "HADS only at baseline (24 h before surgery); no depression measure after surgery. Primary outcome AIS. Postoperative IV-PCA contents not stated; study drug described only as the intraoperative infusion. No ethics approval, registration, country, or inclusion criteria in the text." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 166, "registration_shared_with": [] }, { "trial": "T080", "source": "fulltext", "source_record": "pmid:41312464", "records": [ "pmid:41312464" ], "design": { "id": "T080", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Low-dose group (L)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.0208, "infusion_hours": 24, "pump": true, "pump_total_mg": null, "dose_note": "0.5 mg/kg in 48 mL at 2 mL/h for 24 h by a separate pump started immediately after surgery", "start": "postoperative", "end": "after_emergence" }, { "name": "High-dose group (H)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.0313, "infusion_hours": 24, "pump": true, "pump_total_mg": null, "dose_note": "0.75 mg/kg in 48 mL at 2 mL/h for 24 h by a separate pump started immediately after surgery", "start": "postoperative", "end": "after_emergence" }, { "name": "Control group (C)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "orthopedic surgery for traumatic lower limb fracture", "depression_selection": "selected", "selection_criterion": "HAMD-17 >= 7 on admission, no prior major depression diagnosis", "age_group": "adult", "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 1, 3, 7 ], "primary": true } ], "pain_measures": [ { "measure": "total postoperative sufentanil consumption over 48 h", "code": "opioid", "days": [ 2 ], "primary": true }, { "measure": "VAS (4, 8, 12, 24, 48 h)", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "PCA compressions", "code": "opioid", "days": [ 2 ], "primary": false }, { "measure": "total intraoperative sufentanil consumption", "code": "opioid", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2021-09", "end": "2024-06" }, "ethics_approval": true, "planned_n": 225, "country": "China", "centers": "single", "note": "Esketamine only by a 24 h postoperative infusion started immediately after surgery, so some; control got a saline pump. Enrolled HAMD-17 >= 7, coded selected. No registration stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 1.25, "pump_only": true, "size": 225, "registration_shared_with": [] }, { "trial": "T081", "source": "fulltext", "source_record": "pmid:41285329", "records": [ "pmid:41285329" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": { "first_submitted": "2024-09-19", "start": "2024-09-23" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.6, "pump_only": false, "size": 142, "registration_shared_with": [] }, { "trial": "T082", "source": "fulltext", "source_record": "pmid:41209150", "records": [ "pmid:41209150" ], "design": { "id": "T082", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control (Group C)", "role": "control" }, { "name": "Esketamine (Group E)", "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": "only in PCIA: esketamine 0.5 mg/kg + sufentanil 2 ug/kg in 100 mL, 2 mL/h background (stated as about 0.01 mg/kg/h), 2 mL bolus, 15 min lockout, started after cord clamping", "start": "after_delivery", "end": "after_emergence" }, { "name": "Esketamine-dexmedetomidine (Group ED)", "role": "other", "dose_note": "adds dexmedetomidine 1 ug/kg to the esketamine PCIA" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "planned cesarean delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS (depression)", "code": "HADS_D", "days": [ 2 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest (6, 12, 24, 48, 72 h)", "code": "rest", "days": [ 0, 1, 2, 3 ], "primary": false }, { "measure": "NRS during movement (6, 12, 24, 48, 72 h)", "code": "movement", "days": [ 0, 1, 2, 3 ], "primary": false }, { "measure": "effective and total PCIA presses", "code": "opioid", "days": [], "primary": false }, { "measure": "rescue analgesia frequency (diclofenac)", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2500096770", "date": "2025-02-06" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "Spinal anesthesia, awake; esketamine only by PCIA from cord clamping, so some. HADS subscale not named (described as anxiety and depression levels), coded HADS_D. Primary outcome RCSQ sleep." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2025, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 120, "registration_shared_with": [] }, { "trial": "T083", "source": "fulltext", "source_record": "pmid:41185705", "records": [ "pmid:41185705" ], "design": { "id": "T083", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": 0.25, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "bolus after loss of consciousness at induction; infusion stopped just before skin suturing", "start": "after_induction", "end": "end_of_surgery" }, { "name": "Normal saline group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "unilateral modified radical mastectomy for breast cancer", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 1, 3, 30 ], "primary": true }, { "measure": "Self-Rating Depression Scale (SDS)", "code": "SDS", "days": [ 1, 3, 30 ], "primary": false } ], "pain_measures": [ { "measure": "11-point VAS (30 min after extubation, POD1, POD2)", "code": "other", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200061575", "date": "2022-06-29" }, "enrollment": { "start": "2023-10", "end": "2024-04" }, "ethics_approval": true, "planned_n": 96, "country": "China", "centers": "single", "note": "All dosing under general anesthesia after loss of consciousness; infusion stopped just before skin suturing, coded end_of_surgery and late true. HAMD-17 primary at POD30 (POD1 and 3 secondary)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 96, "registration_shared_with": [] }, { "trial": "T084", "source": "abstract", "source_record": "pmid:40831094", "records": [ "pmid:40831094" ], "design": { "id": "T084", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "S-ketamine", "role": "ketamine", "drug": "esketamine", "route": null, "bolus_mg_per_kg": 0.4, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.4 mg/kg; route and timing not stated", "start": "unclear", "end": "unclear" }, { "name": "Normal saline", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "abdominal tumor resection", "depression_selection": "selected", "selection_criterion": "newly screened mild-to-severe depressive symptoms", "age_group": null, "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 7 ], "primary": true } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": null, "note": "Abstract only. Route, timing, and anesthesia not stated, so conscious dosing unclear. Primary PHQ-9 response on POD1; trajectories over 7 postoperative days (schedule not stated). Adverse events recorded, types not named." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.8, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T085", "source": "fulltext", "source_record": "pmid:40810981", "records": [ "pmid:40810981" ], "design": { "id": "T085", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Study group (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.25, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "infusion from after induction until abdominal closure", "start": "after_induction", "end": "end_of_surgery" }, { "name": "Control group (normal saline)", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "elective open gynecologic surgery for benign indications", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9 (>= 10 = depressive symptoms)", "code": "PHQ9", "days": [ 7 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain at designated time points", "code": "other", "days": [], "primary": false }, { "measure": "total morphine consumption (PACU rescue + PCA) in the first 24 h", "code": "opioid", "days": [ 1 ], "primary": false }, { "measure": "chronic pain (NRS >= 4) at 3 months", "code": "other", "days": [ 90 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200061021", "date": "2022-06-15" }, "enrollment": { "start": "2022-09", "end": "2024-03" }, "ethics_approval": true, "planned_n": 140, "country": "China", "centers": "single", "note": "General anesthesia plus TAP block; infusion from after induction until abdominal closure, so none and late true. Morphine PCA without esketamine. Primary outcome QoR-40." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 140, "registration_shared_with": [] }, { "trial": "T086", "source": "fulltext", "source_record": "pmid:40791037", "records": [ "pmid:40791037" ], "design": { "id": "T086", "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": false, "pump_total_mg": null, "dose_note": "single dose within 10 min after fetal removal", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (postpartum depression incidence, >= 10)", "code": "EPDS", "days": [], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest (4, 8, 12, 24, 48 h)", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "NRS during movement (4, 8, 12, 24, 48 h)", "code": "movement", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "postoperative indomethacin use", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100050976", "date": "2021-09-09" }, "enrollment": { "start": "2022-01-15", "end": "2022-07-30" }, "ethics_approval": true, "planned_n": 288, "country": "China", "centers": "single", "note": "Spinal anesthesia, awake, so some. Postoperative EPDS timing not stated (sample size cites day-3 incidence). SDS given only before surgery. PCIA without esketamine." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 288, "registration_shared_with": [] }, { "trial": "T087", "source": "fulltext", "source_record": "pmid:40739637", "records": [ "pmid:40739637" ], "design": { "id": "T087", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group K (study group)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single 0.5 mg/kg IV bolus right after propofol 1 mg/kg + fentanyl induction", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Group C (control group)", "role": "control" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "day-case fractional curettage", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "POMS depression-dejection subscale (within total mood score)", "code": "POMS_D", "days": [ 0 ], "primary": false } ], "pain_measures": [ { "measure": "NRS 120 min after surgery", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": 124, "country": "Turkey", "centers": "single", "note": "Procedural IV anaesthesia (propofol 1 mg/kg + fentanyl) breathing spontaneously by nasal mask, no airway device named, so coded sedation and, per the codebook, some. Ketamine bolus was given after induction of a short procedure, so it was likely still acting at waking. Primary outcome POMS total mood score at 120 min; the depression-dejection subscale is part of it. No ethics approval or registration stated in this text. The total mood score is a global affect score, not a depression measure, so only the depression-dejection subscale is listed." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 124, "registration_shared_with": [] }, { "trial": "T088", "source": "fulltext", "source_record": "pmid:40607793", "records": [ "pmid:40607793" ], "design": { "id": "T088", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group A", "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 after delivery and cord cutting; PCIA esketamine 1 mg/kg + sufentanil 1.5 ug/kg + nalbuphine 0.5 mg/kg in 100 mL (2 mL/h, 0.5 mL bolus, 15 min lockout) from the end of surgery", "start": "after_delivery", "end": "after_emergence" }, { "name": "Group B", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg after delivery and cord cutting; PCIA without esketamine", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Group C", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective medically indicated cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 3, 5, 7, 14, 30, 42 ], "primary": true } ], "pain_measures": [ { "measure": "VAS (4, 12, 24, 48 h)", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "PCIA bolus times", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400080617", "date": "2024-02-02" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 186, "country": "China", "centers": "single", "note": "Combined spinal-epidural, awake; esketamine after delivery (plus PCIA in group A), so some. Text includes the abstract's results and the introduction, ignored. Excluded preoperative depression." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 186, "registration_shared_with": [] }, { "trial": "T089", "source": "fulltext", "source_record": "pmid:40599293", "records": [ "pmid:40599293" ], "design": { "id": "T089", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esk 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 at induction; infusion until 20 min before the end of surgery", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "NS group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "thoracoscopic radical lung cancer surgery in frail older patients", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 7, 30 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest (24, 48 h)", "code": "rest", "days": [ 1, 2 ], "primary": false }, { "measure": "NRS on coughing (24, 48 h)", "code": "movement", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2023-08", "end": "2024-06" }, "ethics_approval": true, "planned_n": 88, "country": "China", "centers": "single", "note": "Chinese text. General anesthesia plus erector spinae block; bolus at induction, infusion stopped 20 min before the end, so none and late true (infusion ran into the last 30 min). Postoperative pump of sufentanil and dezocine without esketamine. Enrolled FRAIL >= 3." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 88, "registration_shared_with": [] }, { "trial": "T090", "source": "fulltext", "source_record": "pmid:40596895", "records": [ "pmid:40596895" ], "design": { "id": "T090", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control group (group C)", "role": "control" }, { "name": "Esketamine group S1", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.15, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "induction dose; maintenance esketamine (rate not stated) until 30 min before the end of surgery", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Esketamine group S2", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "induction dose; maintenance esketamine (rate not stated) until 30 min before the end of surgery", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Esketamine group S3", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.35, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "induction dose; maintenance esketamine (rate not stated) until 30 min before the end of surgery", "start": "at_induction", "end": "before_end_of_surgery" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "radical thyroidectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS depression subscale", "code": "HADS_D", "days": [], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest (3, 6, 12, 24, 48 h)", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "NRS during exercise (3, 6, 12, 24, 48 h)", "code": "movement", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "sufentanil consumption", "code": "opioid", "days": [], "primary": false }, { "measure": "additional analgesic needs", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400090449", "date": null }, "enrollment": { "start": "2023-03", "end": "2024-03" }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "Induction dose with the induction agents; esketamine stopped 30 min before the end (stated twice), so late false, though one sentence lists esketamine among agents stopped after skin closure. Maintenance rate not given. Single-blind, party not named. Called multicenter but all patients from one hospital. HADS timing not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 120, "registration_shared_with": [] }, { "trial": "T091", "source": "fulltext", "source_record": "pmid:40385271", "records": [ "pmid:40385271" ], "design": { "id": "T091", "eligible": false, "exclusion_reason": "no_inert_control", "timing_comparison": false, "arms": [ { "name": "Control group", "role": "other", "dose_note": "postoperative IV sufentanil 2.5 ug/kg for 48 h" }, { "name": "Experimental (observation) 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": "postoperative PCIA via central line: esketamine 2 mg/kg + sufentanil 2.0 ug/kg over 48 h", "start": "postoperative", "end": "after_emergence" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "cardiac surgery with cardiopulmonary bypass", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "HAMD", "code": "HAMD", "days": [ 2 ], "primary": false } ], "pain_measures": [ { "measure": "VAS (4, 8, 24, 48 h)", "code": "other", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "PCIA presses", "code": "opioid", "days": [ 0, 1, 2 ], "primary": true } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400092428", "date": null }, "enrollment": { "start": "2021-01", "end": "2023-12" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Control pump has more sufentanil (2.5 against 2.0 ug/kg) and no placebo: opioid-sparing substitution, so no inert control. Esketamine only by the 48 h postoperative PCIA, so some." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": true, "size": null, "registration_shared_with": [] }, { "trial": "T092", "source": "fulltext", "source_record": "pmid:40324271", "records": [ "pmid:40324271" ], "design": { "id": "T092", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group (group E)", "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 dose during induction of general anesthesia", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Saline group (group C)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "thyroid cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Zung Self-Rating Depression Scale (SDS)", "code": "SDS", "days": [ 1 ], "primary": true } ], "pain_measures": [ { "measure": "VAS after recovery", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200063302", "date": null }, "enrollment": { "start": "2023-02", "end": "2023-06" }, "ethics_approval": true, "planned_n": 80, "country": "China", "centers": "single", "note": "Single induction dose under general anesthesia, so none; late false. SDS on the day after surgery. Participant blinding not stated; outcomes evaluated by a blinded anesthesiologist." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 1.0, "pump_only": false, "size": 80, "registration_shared_with": [] }, { "trial": "T093", "source": "library", "source_record": "pmid:40153893", "records": [ "pmid:40153893" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.503, "pump_only": false, "size": 108, "registration_shared_with": [] }, { "trial": "T094", "source": "fulltext", "source_record": "pmid:40045195", "records": [ "pmid:40045195" ], "design": { "id": "T094", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control group", "role": "control" }, { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.3, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "infusion from 10 min before induction until the end of surgery", "start": "before_induction", "end": "end_of_surgery" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "laparoscopic abdominal surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 3 ], "primary": false } ], "pain_measures": [ { "measure": "VAS (24, 48 h)", "code": "other", "days": [ 1, 2 ], "primary": false }, { "measure": "rescue analgesia rate", "code": "other", "days": [], "primary": false }, { "measure": "opioid consumption", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400087795", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 174, "country": "China", "centers": "single", "note": "Infusion started 10 min before induction, awake, so some; it ran to the end of surgery. General anesthesia implied by 'induction of anesthesia'. 174 planned, 200 enrolled. No primary outcome named (sample size on POD1 sleep disturbance)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 174, "registration_shared_with": [] }, { "trial": "T095", "source": "fulltext", "source_record": "pmid:39946130", "records": [ "pmid:39946130" ], "design": { "id": "T095", "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": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg in 20 mL over 20 min after fetal delivery", "start": "after_delivery", "end": "unclear" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery (elective or emergency)", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "NRS with movement", "code": "movement", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "PCIA agent consumption and bolus frequency", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2023-03", "end": "2024-02" }, "ethics_approval": true, "planned_n": 308, "country": "China", "centers": "single", "note": "Intraspinal anesthesia, awake, so some. 20-min infusion after delivery; its end relative to the end of surgery not stated. Fentanyl PCIA without esketamine. Adverse events from an open-ended inquiry, not named. No registration or age limits stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 308, "registration_shared_with": [] }, { "trial": "T096", "source": "fulltext", "source_record": "pmid:39577234", "records": [ "pmid:39577234" ], "design": { "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)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2020, "registry_dates": { "first_submitted": "2020-11-17", "start": "2020-11-17" }, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 40, "registration_shared_with": [] }, { "trial": "T097", "source": "fulltext", "source_record": "pmid:39168917", "records": [ "pmid:39168917" ], "design": { "id": "T097", "eligible": true, "exclusion_reason": null, "timing_comparison": true, "arms": [ { "name": "Post-ESK group", "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": "0.2 mg/kg (adjusted body weight) infused IV within 10 min after induction", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Pre-ESK group", "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": "0.2 mg/kg (adjusted body weight) IV infusion 2 h before induction", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": false, "setting": "surgery", "procedure": "laparoscopic sleeve gastrectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 1, 2 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain score", "code": "other", "days": [ 1, 2 ], "primary": false }, { "measure": "PCA pump presses (sufentanil/oxycodone pump)", "code": "opioid", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2100050874", "date": "2021-09-05" }, "enrollment": { "start": "2021-09", "end": "2023-05" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Pre-ESK got esketamine 2 h before induction while awake, so conscious_dosing is some for the ketamine arms together; Post-ESK's only dose was within 10 min after induction under GA (late_dosing false refers to it). timing_comparison true because the two ketamine arms differ only in timing (a saline arm is also present). TAP block given in PACU after surgery. Registration date read as 5 Sep 2021. 120 enrolled (3 x 40), no planned size stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T098", "source": "fulltext", "source_record": "pmid:40297147", "records": [ "pmid:40297147" ], "design": { "id": "T098", "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": true, "pump_total_mg": null, "dose_note": "PCIA only: esketamine 1 mg/kg/day + sufentanil 1 ug/kg/day in 100 mL; background 2 mL/h, bolus 2 mL, lockout 15 min", "start": "end_of_surgery", "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": [], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 0, 1 ], "primary": true }, { "measure": "VAS on cough", "code": "movement", "days": [ 0, 1 ], "primary": true } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400082094", "date": "2024-03-20" }, "enrollment": { "start": "2024-05", "end": "2024-11" }, "ethics_approval": true, "planned_n": 100, "country": "China", "centers": "single", "note": "No depression scale or depression outcome in the Methods (pain primary, side effects secondary). Esketamine only in the PCIA pump started at the end of surgery under spinal anesthesia; control PCIA sufentanil alone. Patients' blinding not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 100, "registration_shared_with": [] }, { "trial": "T099", "source": "fulltext", "source_record": "pmid:40804260", "records": [ "pmid:40804260" ], "design": { "id": "T099", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "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 IV injection immediately after the beginning of surgery", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Saline group", "role": "control" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "first-trimester surgical abortion", "depression_selection": "unselected", "selection_criterion": "poor sleep (PSQI > 5), not depression", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 2, 3, 7 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 2, 3, 7 ], "primary": false }, { "measure": "NRS after movement", "code": "movement", "days": [ 0, 1, 2, 3, 7 ], "primary": false }, { "measure": "acetaminophen use", "code": "other", "days": [ 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT06388824", "date": null }, "enrollment": { "start": "2024-05-05", "end": "2024-10-31" }, "ethics_approval": true, "planned_n": 204, "country": "China", "centers": "single", "note": "Propofol/fentanyl IV anesthesia titrated to MOAA/S <=2 and BIS 45-60 with nasal-cannula oxygen and spontaneous breathing, no airway device: coded sedation, so conscious_dosing some per the codebook, although the dose came at the start of surgery after propofol induction (deeply sedated). Enrolled poor sleepers (PSQI >5), not selected for depression. Primary outcome insomnia (AIS)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": { "first_submitted": "2024-04-25", "start": "2024-05-03" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 204, "registration_shared_with": [] }, { "trial": "T100", "source": "fulltext", "source_record": "pmid:42723442", "records": [ "pmid:42723442" ], "design": { "id": "T100", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group (PE)", "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 at induction in place of saline; PCIA esketamine 1 mg/kg + sufentanil 2 ug/kg in 100 mL, 1.5 mL/h background, ~48 h", "start": "at_induction", "end": "after_emergence" }, { "name": "Control group (C)", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "laparoscopic radical resection of colorectal cancer", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS depression score", "code": "HADS_D", "days": [ 1, 3, 7 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300075055", "date": "2023-08-23" }, "enrollment": { "start": "2023-09", "end": "2024-02" }, "ethics_approval": true, "planned_n": 130, "country": "China", "centers": "single", "note": "Esketamine PCIA used after waking makes conscious_dosing some. Induction bolus early under GA; when the PCIA started is not stated, so late_dosing null. TAP block for all (timing not stated). Primary outcome HADS-A POD1; HADS depression secondary." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 1.0, "pump_only": false, "size": 130, "registration_shared_with": [] }, { "trial": "T101", "source": "fulltext", "source_record": "pmid:42713505", "records": [ "pmid:42713505" ], "design": { "id": "T101", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": 0.1, "infusion_hours": null, "pump": true, "pump_total_mg": null, "dose_note": "0.2 mg/kg slowly before incision, then 0.1 mg/kg/h until end of operation; PCIA esketamine 1 mg/kg + sufentanil 3 ug/kg in 150 mL, 2 mL/h, 72 h, started in the OR at end of surgery", "start": "after_induction", "end": "after_emergence" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "major abdominal tumor surgery (gynecological, colorectal, gastric)", "depression_selection": "unselected", "selection_criterion": "preoperative anxiety (HAMA > 7), not depression", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-8", "code": "PHQ9", "days": [ 3, 30 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain", "code": "other", "days": [ 0, 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT06530706", "date": "2024-07-31" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 180, "country": "China", "centers": "single", "note": "Enrolled only patients with preoperative anxiety (HAMA >7), not selected for depression. Intraoperative infusion ran to end of surgery and the esketamine PCIA continued after waking: some, late true. TAP block in the pre-anesthesia room for all. Only nausea and vomiting named as recorded adverse events." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": { "first_submitted": "2024-07-29", "start": "2024-08-05" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 180, "registration_shared_with": [] }, { "trial": "T102", "source": "fulltext", "source_record": "pmid:42602089", "records": [ "pmid:42602089" ], "design": { "id": "T102", "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": 0.3, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "esketamine 1 mg/mL at 0.3 mL/kg/h from after delivery throughout surgery; no bolus", "start": "after_delivery", "end": "end_of_surgery" }, { "name": "Normal saline control group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "cesarean", "procedure": "elective cesarean section under general anesthesia (LMA)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 3, 7, 42 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain", "code": "other", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "rescue analgesia rate (butorphanol)", "code": "opioid", "days": [ 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300078490", "date": null }, "enrollment": { "start": "2024-01", "end": "2025-08" }, "ethics_approval": true, "planned_n": 160, "country": "China", "centers": "single", "note": "Infusion started after delivery under GA (LMA, mechanical ventilation) and ran throughout surgery: none, late true. Bilateral transversalis fascia plane blocks given after surgery, before LMA removal; PCIA contents not stated (no esketamine named). Excluded preoperative EPDS >=13. Primary outcome sleep disorder POD3." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 160, "registration_shared_with": [] }, { "trial": "T103", "source": "fulltext", "source_record": "pmid:42484088", "records": [ "pmid:42484088" ], "design": { "id": "T103", "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": 0.125, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg before incision, then 0.125 mg/kg/h until skin closure", "start": "after_induction", "end": "end_of_surgery" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "minimally invasive McKeown esophagectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 2, 3 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest (24-h average)", "code": "rest", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "NRS during movement (24-h average)", "code": "movement", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "BPI pain severity and interference", "code": "other", "days": [ 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400088916", "date": "2024-08-29" }, "enrollment": { "start": "2024-10", "end": "2025-01" }, "ethics_approval": true, "planned_n": 210, "country": "China", "centers": "multi", "note": "Doses only under GA (bolus after induction before incision; infusion to skin closure): none, late true. Intercostal nerve block by the surgeon at the end of the thoracic phase and TAP block in PACU. Four centers. Primary outcome QoR-15 POD2." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 210, "registration_shared_with": [] }, { "trial": "T104", "source": "fulltext", "source_record": "pmid:42449469", "records": [ "pmid:42449469" ], "design": { "id": "T104", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "N group (saline)", "role": "control" }, { "name": "L group (lidocaine)", "role": "other", "dose_note": "lidocaine 1.5 mg/kg then 1.5 mg/kg/h" }, { "name": "A group (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": 0.2, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.2 mg/kg loading then 0.2 mg/kg/h, started within 10 min before induction, until end of surgery", "start": "before_induction", "end": "end_of_surgery" }, { "name": "LA group (lidocaine + esketamine)", "role": "other", "dose_note": "lidocaine and esketamine at the same doses" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "functional endoscopic sinus surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Zung SDS", "code": "SDS", "days": [ 1, 2 ], "primary": false } ], "pain_measures": [ { "measure": "QoR-40 pain dimension", "code": "other", "days": [ 1, 2, 7 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": "2024-05", "end": "2025-12" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Secondary analysis of a four-arm randomized parent trial (1:1:1:1). Loading dose started up to 10 min before induction while awake, so some; infusion ran to end of surgery under GA (late true). LA arm adds lidocaine, coded other. No registration or planned size stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T105", "source": "fulltext", "source_record": "pmid:42396903", "records": [ "pmid:42396903" ], "design": { "id": "T105", "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": 0.2, "infusion_hours": 1, "pump": true, "pump_total_mg": null, "dose_note": "0.2 mg/kg/h for 1 h after induction; PCIA esketamine 1 mg/kg + sufentanil 1 ug/kg in 100 mL, 2 mL/h, set up at end of surgery (~48 h)", "start": "after_induction", "end": "after_emergence" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "acoustic neuroma resection", "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 rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "VAS during movement", "code": "movement", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "intraoperative opioid consumption (morphine equivalents)", "code": "opioid", "days": [ 0 ], "primary": false }, { "measure": "rescue analgesia within 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400084537", "date": "2024-05-20" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 84, "country": "China", "centers": "single", "note": "Esketamine PCIA set up at the end of surgery and used after waking: some; late true because the pump began at the end of surgery under GA (the 1-h intraoperative infusion itself ended early). Primary outcome incidence of depression (HADS-D >7) on POD1. Excluded HADS subscore >10." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 84, "registration_shared_with": [] }, { "trial": "T106", "source": "fulltext", "source_record": "pmid:42375601", "records": [ "pmid:42375601" ], "design": { "id": "T106", "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": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg at induction and another 0.25 mg/kg at skin suture", "start": "at_induction", "end": "end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "non-cardiac thoracic surgery with one-lung ventilation", "depression_selection": "unselected", "selection_criterion": "poor sleep (PSQI >= 7), not depression", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 3, 5 ], "primary": false } ], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 0, 1, 3, 5 ], "primary": false }, { "measure": "VAS during movement (coughing/deep breathing)", "code": "movement", "days": [ 0, 1, 3, 5 ], "primary": false }, { "measure": "hydromorphone intake", "code": "opioid", "days": [ 1, 2 ], "primary": false }, { "measure": "intraoperative opioid consumption", "code": "opioid", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2500096036", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 100, "country": "China", "centers": "single", "note": "Two boluses under GA, at induction and at skin suture: none, late true (dose at end of surgery). Intercostal block before the end of surgery. Enrolled poor sleepers (PSQI >=7), not selected for depression. Patients blinded (allocation not revealed until discharge)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2025, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 100, "registration_shared_with": [] }, { "trial": "T107", "source": "fulltext", "source_record": "pmid:42369371", "records": [ "pmid:42369371" ], "design": { "id": "T107", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Bolus group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg IV over 20 s after cord clamping, then a saline infusion", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Infusion group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.75, "infusion_hours": 0.33, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg infused over 20 min after cord clamping (saline bolus first)", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean delivery under spinal anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 28, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "NRS with movement (coughing or walking)", "code": "movement", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "PCIA usage (fentanyl)", "code": "opioid", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400082919", "date": null }, "enrollment": { "start": "2024-04", "end": "2025-04" }, "ethics_approval": true, "planned_n": 503, "country": "China", "centers": "single", "note": "All doses given awake under spinal anesthesia: some. Double-dummy bolus plus 20-min infusion in every arm. Excluded prenatal EPDS >=10. Adverse events collected only by an open-ended question; no psychotomimetic events named. TAP block at end of surgery for all." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.497, "pump_only": false, "size": 503, "registration_shared_with": [] }, { "trial": "T108", "source": "fulltext", "source_record": "pmid:42286774", "records": [ "pmid:42286774" ], "design": { "id": "T108", "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 1.5 mg/kg + sufentanil 2 ug/kg in 150 mL, 1 mL/h basal, 2 mL bolus, >72 h", "start": "postoperative", "end": "after_emergence" }, { "name": "Control group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "pancreaticoduodenectomy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 1, 2, 3, 5 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 0, 1, 2, 3, 5 ], "primary": false }, { "measure": "total postoperative sufentanil dose", "code": "opioid", "days": [], "primary": false }, { "measure": "PCIA presses, supplemental and rescue analgesics", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200066303", "date": "2022-11-30" }, "enrollment": { "start": "2023-01", "end": "2024-12" }, "ethics_approval": true, "planned_n": 80, "country": "China", "centers": "single", "note": "Esketamine only in the postoperative PCIA pump: some; pump start time not stated, so late_dosing null. Primary outcome incidence of depression on POD3; HAMD-17 is the only depression scale named (its scores are listed as secondary). Only generic adverse events named." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": true, "size": 80, "registration_shared_with": [] }, { "trial": "T109", "source": "fulltext", "source_record": "pmid:42261442", "records": [ "pmid:42261442" ], "design": { "id": "T109", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group S (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single IV bolus at skin incision", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Group C (saline)", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective surgery in adolescents (general, thoracic, orthopedic, vascular, ENT, oral)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adolescent", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 3, 7, 14 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest (AUC over 48 h)", "code": "rest", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT06073015", "date": "2023-10-27" }, "enrollment": { "start": "2023-11", "end": "2024-12" }, "ethics_approval": true, "planned_n": 88, "country": "China", "centers": "single", "note": "Single bolus at skin incision under GA: none. late_dosing false since the dose came at the start of surgery; surgery lengths not given, and in a very short procedure it could fall within 30 min of the end. Nerve blocks before induction only for limb and thoracic procedures. HADS anxiety and depression named as primary outcomes (sample size from HADS-A POD3). Ages 13-18." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": { "first_submitted": "2023-10-03", "start": "2023-10-10" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 88, "registration_shared_with": [] }, { "trial": "T110", "source": "fulltext", "source_record": "pmid:42148362", "records": [ "pmid:42148362" ], "design": { "id": "T110", "eligible": false, "exclusion_reason": "no_inert_control", "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 during induction; PCIA esketamine 1 mg/kg + sufentanil 1 ug/kg + flurbiprofen in 100 mL, 2 mL/h, 48 h", "start": "at_induction", "end": "after_emergence" }, { "name": "Control group", "role": "other", "dose_note": "saline at induction; PCIA sufentanil 2 ug/kg (double the esketamine arm's) + flurbiprofen" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "emergency laparoscopic salpingectomy for ectopic pregnancy", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [ 7 ], "primary": false } ], "pain_measures": [ { "measure": "Pain Sensitivity Questionnaire", "code": "other", "days": [ 1, 2, 7 ], "primary": true }, { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "NRS dynamic (thigh flexion/extension)", "code": "movement", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "PCIA activations", "code": "opioid", "days": [], "primary": false }, { "measure": "rescue flurbiprofen use", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT06559280", "date": null }, "enrollment": { "start": "2024-08-24", "end": "2025-05-20" }, "ethics_approval": true, "planned_n": 84, "country": "China", "centers": "single", "note": "The control PCIA deliberately held twice the sufentanil (2 vs 1 ug/kg) to offset esketamine's analgesia, so the saline arm did not otherwise get the same care as the ketamine arm: no_inert_control (control arm coded other). If counted as eligible: conscious_dosing some (esketamine PCIA after waking)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": { "first_submitted": "2024-08-11", "start": "2024-08-24" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 84, "registration_shared_with": [] }, { "trial": "T111", "source": "fulltext", "source_record": "pmid:42125734", "records": [ "pmid:42125734" ], "design": { "id": "T111", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": 0.25, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg over 10 min before induction (after midazolam 0.05 mg/kg), then 0.25 mg/kg/h until end of surgery", "start": "before_induction", "end": "end_of_surgery" }, { "name": "Group M (magnesium sulfate)", "role": "other", "dose_note": "magnesium sulfate 30 mg/kg over 10 min, then 10 mg/kg/h" }, { "name": "Group C (saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "functional endoscopic sinus surgery or septoplasty", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS (depression subscale)", "code": "HADS_D", "days": [ 1, 2 ], "primary": true }, { "measure": "Zung SDS", "code": "SDS", "days": [ 1, 2 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "rescue ketorolac requirement", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT06920576", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 144, "country": "China", "centers": "single", "note": "Bolus given over 10 min before induction (awake after light midazolam): some; infusion ran to end of surgery (late true). Primary outcome 'HADS scores' POD1-2 with sample size from HADS-A, so the subscales are scored separately; coded HADS_D." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2025, "registry_dates": { "first_submitted": "2025-03-14", "start": "2025-03-01" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 144, "registration_shared_with": [] }, { "trial": "T112", "source": "fulltext", "source_record": "pmid:42119799", "records": [ "pmid:42119799" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2020, "registry_dates": { "first_submitted": "2020-06-08", "start": "2021-02-19" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.402, "pump_only": false, "size": 564, "registration_shared_with": [] }, { "trial": "T113", "source": "fulltext", "source_record": "pmid:42014775", "records": [ "pmid:42014775" ], "design": { "id": "T113", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "ES1 group", "role": "ketamine", "drug": "esketamine", "route": null, "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "esketamine regimen given only in Table 1 (not available)", "start": "unclear", "end": "unclear" }, { "name": "ES2 group", "role": "ketamine", "drug": "esketamine", "route": null, "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "esketamine regimen given only in Table 1 (not available)", "start": "unclear", "end": "unclear" }, { "name": "C group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "elective radical colorectal cancer surgery in older adults", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HAMD", "code": "HAMD", "days": [], "primary": false } ], "pain_measures": [ { "measure": "VAS at rest (24 h)", "code": "rest", "days": [ 1 ], "primary": false }, { "measure": "VAS on activity (24 h)", "code": "movement", "days": [ 1 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300070763", "date": null }, "enrollment": { "start": "2023-05-01", "end": "2024-01-01" }, "ethics_approval": true, "planned_n": 99, "country": "China", "centers": "single", "note": "The three arms and their doses and timing are in a table not provided; esketamine arms inferred from the group names, the esketamine-allergy exclusion, and identical opaque bags prepared by a pharmacist, with C as the placebo control. PCA contents also in a missing table, so conscious_dosing unclear. Postoperative HAMD timing not stated (correlated with 24-h VAS)." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 99, "registration_shared_with": [] }, { "trial": "T114", "source": "fulltext", "source_record": "pmid:41987070", "records": [ "pmid:41987070" ], "design": { "id": "T114", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "ES 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": "0.25 mg/kg after induction, then 0.125 mg/kg/h until 30 min before end of surgery", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective non-intracranial surgery in Parkinson's disease", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "Zung SDS", "code": "SDS", "days": [ 1, 3, 7 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 1 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2500098063", "date": null }, "enrollment": { "start": "2024-11", "end": "2025-08" }, "ethics_approval": true, "planned_n": 58, "country": "China", "centers": "single", "note": "All doses under GA; infusion stopped 30 min before the end of surgery, i.e. not within the last 30 min, so late false (boundary case). Excluded severe depression (SDS >72) and antidepressant use. Ages 60-90. Dissociative symptoms named among the esketamine adverse effects monitored." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2025, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 58, "registration_shared_with": [] }, { "trial": "T115", "source": "library", "source_record": "pmid:41949829", "records": [ "pmid:41949829" ], "design": { "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": "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": "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "ketamine", "dose_ketamine_equivalent_mg_per_kg": 0.503, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T116", "source": "fulltext", "source_record": "pmid:41868913", "records": [ "pmid:41868913" ], "design": { "id": "T116", "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": 0.3, "infusion_hours": 0.67, "pump": false, "pump_total_mg": null, "dose_note": "0.2 mg/kg infused over 40 min starting immediately after cord clamping", "start": "after_delivery", "end": "unclear" }, { "name": "Normal saline group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under combined spinal-epidural anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 2, 7 ], "primary": true } ], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 1 ], "primary": false }, { "measure": "VAS during movement", "code": "movement", "days": [ 1 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": null }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400088992", "date": null }, "enrollment": { "start": "2024-08", "end": "2025-08" }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "Awake under CSE for the whole infusion: some. The 40-min infusion from delivery may have outlasted surgery (end unclear). Single-blind: mothers blinded, anesthesiologists not; assessor blinding not stated. 136 randomized, no planned size stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.402, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T117", "source": "fulltext", "source_record": "pmid:41859850", "records": [ "pmid:41859850" ], "design": { "id": "T117", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Experimental group (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.75, "infusion_hours": 0.33, "pump": false, "pump_total_mg": null, "dose_note": "0.2-0.3 mg/kg by pump over 20 min immediately after induction and intubation (rate 0.6-0.9 mg/kg/h, midpoint coded)", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "repeat trauma repair surgery", "depression_selection": "selected", "selection_criterion": "PHQ-9 >=10 and MADRS >=22", "age_group": "adult", "depression_measures": [ { "measure": "MADRS", "code": "MADRS", "days": [ 1, 2, 3 ], "primary": true }, { "measure": "PHQ-9", "code": "PHQ9", "days": [ 3 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain", "code": "other", "days": [ 0, 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300078540", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 130, "country": "China", "centers": "multi", "note": "20-min infusion right after intubation under GA: none. late false: the dose ended about 20 min into anesthesia; surgeries estimated under 30 min were excluded, actual durations not given. Video follow-ups at 2 weeks and 1 month may include MADRS/PHQ-9 (not explicit). YMRS, BPRS, CADSS recorded." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.495, "pump_only": false, "size": 130, "registration_shared_with": [] }, { "trial": "T118", "source": "fulltext", "source_record": "pmid:41792101", "records": [ "pmid:41792101" ], "design": { "id": "T118", "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": false, "dose_note": "0.25 mg/kg in 20 mL given over the initial 40 min of anesthesia", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Saline placebo group", "role": "control" }, { "name": "Healthy controls (HC)", "role": "other" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective breast cancer resection", "depression_selection": "selected", "selection_criterion": "PHQ-9 >= 5 and MADRS >= 12 (mild-to-severe depressive symptoms)", "age_group": "adult", "depression_measures": [ { "measure": "MADRS", "code": "MADRS", "days": [ 1, 2, 3, 4, 5, 28, 84 ], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2300071062", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": null, "country": "China", "centers": "single", "note": "MRI secondary analysis of the randomized EASE trial (83 of 108 randomized). Drug given over the first 40 min of propofol TIVA, so 'none'; late false because it ended 40 min into anesthesia, though surgery duration isn't stated. Depression instrument at follow-up visits not named outright; MADRS is the scale analysed. Healthy controls are not a randomized arm." }, "decided_by": "third reader", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": null, "registration_shared_with": [] }, { "trial": "T119", "source": "fulltext", "source_record": "pmid:41663991", "records": [ "pmid:41663991" ], "design": { "id": "T119", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "ES group", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": 0.1, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.2 mg/kg during induction, then 0.1 mg/kg/h until end of surgery", "start": "at_induction", "end": "end_of_surgery" }, { "name": "P group (saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "breast cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9", "code": "PHQ9", "days": [ 7, 30 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 1 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": true }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 120, "country": "China", "centers": "single", "note": "Induction dose and infusion to the end of surgery, all under GA: none, late true ('preoperatively' in the aims refers to the induction dose). No registration stated. Only generic adverse events (24 h) named. Primary PHQ-9 at POD30." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": null, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 120, "registration_shared_with": [] }, { "trial": "T120", "source": "fulltext", "source_record": "pmid:41607308", "records": [ "pmid:41607308" ], "design": { "id": "T120", "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": 80, "dose_note": "0.25 mg/kg (ideal body weight) over 60 s, 15 min after cord clamping; PCIA esketamine 80 mg + sufentanil 100 ug in 100 mL, 2 mL/h, 24 h", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under CSEA (primiparae)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 30, 60, 90 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1 ], "primary": false }, { "measure": "effective PCIA presses", "code": "opioid", "days": [ 0, 1 ], "primary": false }, { "measure": "sufentanil consumption", "code": "opioid", "days": [ 0, 1 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT04860661", "date": "2021-04-20" }, "enrollment": { "start": "2021-05-01", "end": "2024-03-31" }, "ethics_approval": true, "planned_n": 336, "country": "China", "centers": "multi", "note": "Bolus given awake under CSEA and esketamine PCIA after surgery: some. Planned size recalculated during the trial from 1248 to 336. Excluded prenatal EPDS >=10. Three hospitals." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2021, "registry_dates": { "first_submitted": "2021-04-20", "start": "2021-05-01" }, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 336, "registration_shared_with": [] }, { "trial": "T121", "source": "library", "source_record": "pmid:41265303", "records": [ "pmid:41265303" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2023, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.5, "pump_only": false, "size": 174, "registration_shared_with": [] }, { "trial": "T122", "source": "fulltext", "source_record": "pmid:40990647", "records": [ "pmid:40990647" ], "design": { "id": "T122", "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": 0.25, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg/h from immediately after induction until abdominal closure; no bolus", "start": "after_induction", "end": "end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": true, "setting": "surgery", "procedure": "gynecologic malignancy laparotomy (midline incision)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9 (>=10)", "code": "PHQ9", "days": [ 7 ], "primary": false } ], "pain_measures": [ { "measure": "verbal NRS pain", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "subacute and chronic pain (NRS >=4)", "code": "other", "days": [ 7, 90 ], "primary": false }, { "measure": "morphine consumption over 48 h", "code": "opioid", "days": [ 0, 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2200062726", "date": "2022-08-16" }, "enrollment": { "start": null, "end": null }, "ethics_approval": true, "planned_n": 140, "country": "China", "centers": "single", "note": "Infusion only under GA, run until abdominal closure: none, late true. TAP block after intubation for all; morphine PCA without esketamine. Primary outcome QoR-40 at 48 h." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2022, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 140, "registration_shared_with": [] }, { "trial": "T123", "source": "library", "source_record": "pmid:40484051", "records": [ "pmid:40484051" ], "design": { "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." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": null, "pump_only": false, "size": 120, "registration_shared_with": [] }, { "trial": "T124", "source": "preprint", "source_record": "ppr:PPR1328500", "records": [ "ppr:PPR1328500" ], "design": { "id": "T124", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group T (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "epidural", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.2 mg/kg in 5 mL via the epidural catheter before skin closure", "start": "end_of_surgery", "end": "end_of_surgery" }, { "name": "Group C (saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section under CSEA", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 42 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "dynamic NRS", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "uterine contraction pain NRS", "code": "other", "days": [ 1, 2 ], "primary": false }, { "measure": "PCIA bolus requests (tramadol)", "code": "opioid", "days": [ 1, 2 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": null, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2400090341", "date": null }, "enrollment": { "start": "2024-10", "end": "2025-05" }, "ethics_approval": true, "planned_n": 88, "country": "China", "centers": "single", "note": "Epidural esketamine given awake under CSEA near skin closure: some. Participants not listed among those blinded. Excluded preoperative anxiety or depression." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2024, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 88, "registration_shared_with": [] }, { "trial": "T125", "source": "preprint", "source_record": "ppr:PPR1281398", "records": [ "ppr:PPR1281398" ], "design": { "id": "T125", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group", "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": "0.2 mg/kg IV over about 30 s immediately after cord clamping", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Control group", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under CSEA", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 1, 3 ], "primary": false } ], "pain_measures": [ { "measure": "VAS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "movement-evoked VAS", "code": "movement", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "effective PCA presses", "code": "opioid", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "rescue butorphanol within 24 h", "code": "opioid", "days": [ 0, 1 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2500099435", "date": null }, "enrollment": { "start": "2025-04", "end": "2025-12" }, "ethics_approval": true, "planned_n": 124, "country": "China", "centers": "single", "note": "Bolus given awake under CSEA after delivery: some. TAP block after skin closure for all; PCA sufentanil and butorphanol without esketamine. Retrospectively registered. Excluded PSQI >5." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2025, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.4, "pump_only": false, "size": 124, "registration_shared_with": [] }, { "trial": "T126", "source": "preprint", "source_record": "ppr:PPR1147046", "records": [ "ppr:PPR1147046" ], "design": { "id": "T126", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group R (ropivacaine ESP block)", "role": "control" }, { "name": "Group K1 (low-dose esketamine)", "role": "ketamine", "drug": "esketamine", "route": "nerve_block", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.25 mg/kg mixed with 0.375% ropivacaine 20 mL in a T5 erector spinae plane block after induction", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Group K2 (high-dose esketamine)", "role": "ketamine", "drug": "esketamine", "route": "nerve_block", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.5 mg/kg mixed with 0.375% ropivacaine 20 mL in the ESP block after induction", "start": "after_induction", "end": "before_end_of_surgery" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "thoracoscopic lung surgery (VATS)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [], "primary": false } ], "pain_measures": [ { "measure": "duration of ESP block analgesia (time to first PCIA use)", "code": "other", "days": [], "primary": true }, { "measure": "VAS at rest", "code": "rest", "days": [], "primary": false }, { "measure": "VAS while coughing", "code": "movement", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ChiCTR", "id": "ChiCTR2000040659", "date": "2020-12-07" }, "enrollment": { "start": "2020-12", "end": "2021-04" }, "ethics_approval": true, "planned_n": 150, "country": "China", "centers": "single", "note": "Esketamine given once perineurally in the ESP block, performed after GA induction and lateral positioning (per the order of the Methods), before surgery: none, late false. Control R got the same ropivacaine block without esketamine. HADS timing not stated." }, "decided_by": "both coders", "notices": [], "design_conflict": false, "registration_year": 2020, "registry_dates": null, "duplicates": [], "drug": "esketamine", "dose_ketamine_equivalent_mg_per_kg": 0.75, "pump_only": false, "size": 150, "registration_shared_with": [] } ]