[ { "id": "T001", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Ketamine 3 mg/kg (oral)", "role": "ketamine", "drug": "ketamine", "route": "oral", "bolus_mg_per_kg": 3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "oral premedication mixed in 0.2 ml/kg cola drink", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Ketamine 6 mg/kg (oral)", "role": "ketamine", "drug": "ketamine", "route": "oral", "bolus_mg_per_kg": 6, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "oral premedication mixed in 0.2 ml/kg cola drink", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "No ketamine (cola drink alone)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "paediatric 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": "Children aged 1-7. Outcomes are sedation, separation, emotional state and emergence phenomena; no depression measure. Premedication drunk awake before induction." }, { "id": "T002", "eligible": false, "exclusion_reason": "no_inert_control", "timing_comparison": false, "arms": [ { "name": "Control group (LA + saline)", "role": "control" }, { "name": "Test group P/M (LA + pentazocine/midazolam)", "role": "other", "dose_note": "pentazocine 0.40 mg/kg + midazolam 0.075 mg/kg iv" }, { "name": "Test group K25/M (LA + ketamine/midazolam)", "role": "other", "drug": "ketamine", "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": "with midazolam 0.075 mg/kg, which the control did not get; 3 min before local anaesthesia", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Test group K50/M (LA + ketamine/midazolam)", "role": "other", "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": "with midazolam 0.075 mg/kg, which the control did not get; 3 min before local anaesthesia", "start": "before_induction", "end": "before_end_of_surgery" } ], "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 (intra- and postoperative)", "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 arms add midazolam that the saline control lacks, so coded other; no arm is ketamine plus only what control gets. Also no depression measure (STAI, VAS, subjective feelings). Conscious sedation." }, { "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 of 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, postoperative epidural analgesia", "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/multimodal 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": "Random allocation not stated (double-blind only). No depression measure either. Ketamine only in postoperative PCEA, given awake." }, { "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": 0.222, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "mean 3.7 (SD 1.5) ug/kg/min with propofol during monitored anesthesia care", "start": "unclear", "end": "unclear" }, { "name": "Propofol group", "role": "control" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "surgery under monitored anesthesia care (propofol sedation)", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "pain after discharge, five-point scale each evening 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. Mood, perception and thought rated by VAS in recovery room; a mood VAS is not a depression scale. Ketamine given during sedation, awake." }, { "id": "T005", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group A (propofol, fentanyl and ketamine induction)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 1.0, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "induction dose; 1.0 mg/kg per the Implications", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group B (propofol and fentanyl induction)", "role": "control" }, { "name": "Group C (non-depressed patients)", "role": "other", "dose_note": "not randomized; non-depressed comparison group" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "orthopedic surgery in patients with major depression", "depression_selection": "selected", "selection_criterion": "major depression", "age_group": null, "depression_measures": [ { "measure": "Hamilton Depression Rating (HDR)", "code": "HAMD", "days": [ 1 ], "primary": false } ], "pain_measures": [ { "measure": "postoperative pain score at 8 and 16 h after anesthesia", "code": "other", "days": [ 0, 1 ], "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 ketamine dose as part of induction. Surgery length not stated; late_dosing false assumes an induction dose precedes the last 30 min. Group C non-randomized." }, { "id": "T006", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "Placebo", "role": "control" }, { "name": "Single preincisional 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, "pump_total_mg": null, "dose_note": "one preincisional injection", "start": "unclear", "end": "before_end_of_surgery" }, { "name": "Preincisional and repeated intraoperative 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, "pump_total_mg": null, "dose_note": "then 0.2 mg/kg every 20 min intraoperatively", "start": "unclear", "end": "unclear" } ], "anesthesia": "general_and_regional", "conscious_dosing": "unclear", "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 analgesic consumption (diclofenac, dextropropoxyphene) 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 was rated but no depression scale is named. Epidural plus general anesthesia; whether the preincisional dose came before or after induction isn't stated." }, { "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 first 24 h", "code": "opioid", "days": [ 1 ], "primary": true }, { "measure": "morphine consumption during titration and 48-h PCA period", "code": "opioid", "days": [ 0, 1, 2 ], "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": "Psychometric tests assess cognitive function; no depression measure. Anesthesia type not stated. Ketamine continued in postoperative PCA (awake)." }, { "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, "pump_total_mg": null, "dose_note": "racemic ketamine in pre-emptive epidural bupivacaine infusion; dose and duration not stated", "start": "unclear", "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", "code": "other", "days": [ 365 ], "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": "Abstract reports long-term mood effects but names no depression scale or assessment; check full text. No general anaesthesia, so epidural ketamine given awake." }, { "id": "T009", "eligible": false, "exclusion_reason": "no_depression_measure", "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": "during anesthetic induction", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Placebo (0.9% saline)", "role": "control" }, { "name": "Nonsurgical group", "role": "other", "dose_note": "not randomized; no surgery" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "cardiac surgery", "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": null, "centers": null, "note": "Outcomes are memory, executive function and CRP; no depression measure." }, { "id": "T010", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "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, "pump_total_mg": null, "dose_note": "with intranasal dexmedetomidine 1 ug/kg, as group D gets; 30 min before surgery", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Group D (dexmedetomidine)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "elective minor surgery in children, intranasal 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": "2014-01", "end": "2015-01" }, "ethics_approval": true, "planned_n": null, "country": "India", "centers": "single", "note": "Both arms get the same dexmedetomidine, so D is the control for DK. No depression measure (separation, mask acceptance, emergence agitation). Premedication given awake. Caudal block when possible." }, { "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, "pump_total_mg": null, "dose_note": "bolus at induction then 30-min infusion", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group C (saline)", "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": true } ], "pain_measures": [ { "measure": "VAS pain", "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": "Infusion stopped 30 min after induction; surgery length not stated, late_dosing false assumes surgery ran past an hour. PHQ-9 primary by stated purpose (not labelled primary)." }, { "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, "pump_total_mg": null, "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 Pain Questionnaire short form and PPI", "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 record. Primary outcome QoR-15. Infusion ran until skin closure began, so late_dosing true. Registry masks only the outcomes assessor. First submitted after the 2014-08 start; 46 enrolled (actual)." }, { "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, "pump_total_mg": null, "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": "surgery under general anesthesia (type not stated)", "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." }, { "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, "pump_total_mg": null, "dose_note": "0.5 mg/kg in 250 ml saline over 1 h, once daily for 7 days (3.5 mg/kg total)", "start": "unclear", "end": "after_emergence" }, { "name": "Group C (saline)", "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_D", "days": [ 5, 90, 180 ], "primary": false } ], "pain_measures": [ { "measure": "VAS pain (PACU, 4 h, 24 h, 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", "code": "other", "days": [ 90, 180 ], "primary": true } ], "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 given awake after surgery; first dose's timing not stated. HADS named without saying which score. PMPS primary by stated objective." }, { "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, "pump_total_mg": null, "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)", "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 caesarean not stated, so whether women were awake for the dose is unclear." }, { "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, "pump_total_mg": null, "dose_note": "single dose 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, "pump_total_mg": null, "dose_note": "single dose 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, 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": "Prespecified secondary analysis of PODCAST, whose primary outcome was delirium; PHQ-8 is this analysis's primary only. Single dose before incision. planned_n is PODCAST's 600." }, { "id": "T017", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group K (ketamine)", "role": "other", "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": "ketamine alone; no arm matches it without ketamine", "start": "after_induction", "end": "before_end_of_surgery" }, { "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, "pump_total_mg": null, "dose_note": "with dexamethasone 0.1 mg/kg, as group D gets; 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": true } ], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [], "primary": false }, { "measure": "PCA consumption", "code": "opioid", "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 saline arm: D (dexamethasone) coded control for KD, which adds only ketamine; K alone coded other. If shared dexamethasone isn't accepted, exclude as no_inert_control. PHQ-9 primary by stated aim." }, { "id": "T018", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Ketamine group", "role": "ketamine", "drug": "ketamine", "route": null, "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "10 min after childbirth; route not stated", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Control group (standard postpartum care)", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [], "primary": true } ], "pain_measures": [ { "measure": "NRS postoperative pain", "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": "China", "centers": null, "note": "Anesthesia not stated, so whether women were awake for the dose is unclear. No placebo; control had standard care. EPDS timing not stated." }, { "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, "pump_total_mg": null, "dose_note": "single dose infused in the PACU", "start": "after_emergence", "end": "after_emergence" }, { "name": "Saline placebo", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "laparoscopic gastric bypass or gastrectomy (bariatric)", "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": "Hypothesis mentions mood scores, but the only outcomes named are pain measures; no depression measure named. Dose given awake in PACU." }, { "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, "pump_total_mg": null, "dose_note": "within 5 min after umbilical 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 under spinal anesthesia", "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", "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 only; dose given awake after cord clamping. Asked about dizziness and hallucination at 5 and 15 min." }, { "id": "T021", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control group (saline)", "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, "pump_total_mg": null, "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, "pump_total_mg": null, "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, "pump_total_mg": null, "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 injection 1 h after induction ('after 1 h of analgesia'); operation time not stated, late_dosing false assumes radical hysterectomy ran well past 90 min." }, { "id": "T022", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "S group (PCIA with 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; 2 mL/h basal + 1-mL demand doses for 48 h", "start": "end_of_surgery", "end": "after_emergence" }, { "name": "C group (PCIA without S-ketamine)", "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 Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 3, 14, 28 ], "primary": true } ], "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": "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": "S-ketamine only in a PCIA started after skin suturing under spinal, so all of it given awake. Registered retroactively." }, { "id": "T023", "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": null, "pump": false, "pump_total_mg": null, "dose_note": "bolus after induction, infusion until the end of surgery", "start": "after_induction", "end": "end_of_surgery" }, { "name": "Group C (saline)", "role": "control" } ], "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_D", "days": [ 2, 90 ], "primary": false } ], "pain_measures": [ { "measure": "NRS pain at 4, 24, 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "chronic pain", "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": "Infusion until the end of surgery, so late_dosing true. HADS named without saying which score. Blinding not stated." }, { "id": "T024", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "RS group (ropivacaine + 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, "pump_total_mg": null, "dose_note": "1 min before surgery, after the CSE block", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "R group (ropivacaine + saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective caesarean delivery under combined spinal-epidural", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS) at discharge", "code": "EPDS", "days": [], "primary": false } ], "pain_measures": [ { "measure": "analgesic effect", "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": "Dose given awake under CSE before incision. EPDS at discharge (day not stated). Primary outcomes were spinal ropivacaine ED90 and hypotension; spinal dose set by an up-down sequence within each group." }, { "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, "pump_total_mg": null, "dose_note": "infused 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": "Abstract doesn't say when the 40-min infusion was given or under what anesthesia, so conscious dosing unclear." }, { "id": "T026", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "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, "pump_total_mg": null, "dose_note": "infused over 20 min after the spinal block, continued whether or not surgery had ended", "start": "after_induction", "end": "after_emergence" }, { "name": "Group C (saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "dilatation and curettage for incomplete 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 with midazolam premedication; ketamine given awake. POMS at 2 h includes a depression subscale, though Methods describe the total score." }, { "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, "pump_total_mg": null, "dose_note": "with thiopental 1-2 mg/kg at induction; control got thiopental 3-5 mg/kg", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Control group (thiopental alone)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "cesarean", "procedure": "caesarean section under general anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 14, 28 ], "primary": true } ], "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 part of thiopental induction; control got a larger thiopental dose instead, otherwise same. EPDS is the sole outcome and basis of the sample size. 'Educational centers' of one university." }, { "id": "T028", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Control group (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, "pump_total_mg": null, "dose_note": "dose, route and timing not stated ('pretreatment')", "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, "pump_total_mg": null, "dose_note": "dose, route and timing not stated ('pretreatment')", "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": true } ], "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, timing or anesthesia, so conscious dosing unclear. HAMD primary by stated objective." }, { "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, "pump_total_mg": null, "dose_note": "bolus during induction (20 s after midazolam, before sufentanil/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-17 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 pain", "code": "other", "days": [ 1, 2, 7 ], "primary": false }, { "measure": "opioid use during hospital stay", "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": "Bolus given as part of induction, after midazolam but before propofol (none per at_induction). Intraoperative infusion's stop time not stated, so late_dosing null." }, { "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, "pump_total_mg": null, "dose_note": "5 min after neonatal 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": "scheduled cesarean delivery under combined spinal-epidural", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Edinburgh Postnatal Depression Scale (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 on 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": "CSE only; dose given awake after delivery." }, { "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, "pump_total_mg": null, "dose_note": "infused over 40 min after cord clamping; continued in PACU if unfinished", "start": "after_delivery", "end": "after_emergence" }, { "name": "Placebo group (saline)", "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": "Edinburgh Postnatal Depression Scale (EPDS)", "code": "EPDS", "days": [ 2, 42 ], "primary": true } ], "pain_measures": [ { "measure": "NRS pain 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 only (general anesthesia excluded); infusion given awake, sometimes finishing in PACU. Pilot trial." }, { "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, "pump_total_mg": null, "dose_note": "50 mg diluted to 20 mL; 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-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 (24 h 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 ran, so conscious dosing unclear. Primary outcome postoperative sleep disturbance. Participants' blinding read from assignments kept until discharge." }, { "id": "T033", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group C (control)", "role": "control" }, { "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 PCIA (sufentanil 1.5 ug/kg + tropisetron 4 mg); 5 mL load, 2 mL/h, 1 mL demand, 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 PCIA (sufentanil 1.5 ug/kg + tropisetron 4 mg); 5 mL load, 2 mL/h, 1 mL demand, 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 PCIA (sufentanil 1.5 ug/kg + tropisetron 4 mg); 5 mL load, 2 mL/h, 1 mL demand, 48 h", "start": "end_of_surgery", "end": "after_emergence" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean delivery under combined spinal-epidural anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "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 analgesia (tramadol) within 48 h", "code": "other", "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": "Drug is named only as 'esketamine group' in the sample-size text. Esketamine only in the PCIA connected at suturing; all women had CSEA (Participants text says general anesthesia, but the procedure describes CSEA for all), so conscious. EPDS not named primary (named primaries are presses, sufentanil, rescue) though the sample size used PPD at 6 weeks. Planned 60 per group x 4 = 240, but 160 envelopes/enrolled." }, { "id": "T034", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "SC group (SC ketamine + IV saline)", "role": "ketamine", "drug": "ketamine", "route": "other", "bolus_mg_per_kg": 0.5, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single subcutaneous injection shortly after delivery", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "IV group (SC saline + IV 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": "0.5 mg/kg in 40 mL infused over 40 min shortly after delivery", "start": "after_delivery", "end": "unclear" }, { "name": "Placebo group (SC saline + IV saline)", "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": [ 1, 2, 21, 42 ], "primary": true } ], "pain_measures": [ { "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 }, { "measure": "maximum intraoperative pain", "code": "other", "days": [ 0 ], "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": "Spinal anesthesia only; study drugs given to awake women shortly after delivery. SC route coded other. 6-week prevalence of EPDS >12 is one of the primary (feasibility) outcomes. IV infusion end relative to end of surgery not stated." }, { "id": "T035", "eligible": false, "exclusion_reason": "no_depression_measure", "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": "infusion until 15 min before the end of surgery; bolus timing not stated", "start": "unclear", "end": "before_end_of_surgery" }, { "name": "Saline group", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": true, "setting": "surgery", "procedure": "video-assisted thoracic surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [], "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": "single", "note": "Abstract cut at Measurements; only quality of recovery is named, no depression measure. Anesthesia and bolus timing not stated; infusion ran to 15 min before the end of surgery, so late if under GA. 80 patients enrolled." }, { "id": "T036", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "K1 group (0.1 mg/kg ketamine)", "role": "ketamine", "drug": "ketamine", "route": "iv", "bolus_mg_per_kg": 0.1, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "single IV dose in 5 mL given 5 min before skin incision, after GA induction and intubation", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "K2 group (0.2 mg/kg ketamine)", "role": "ketamine", "drug": "ketamine", "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 dose in 5 mL given 5 min before skin incision, after GA induction and intubation", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "K3 group (0.3 mg/kg ketamine)", "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 IV dose in 5 mL given 5 min before skin incision, after GA induction and intubation", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "C group (normal saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective colorectal cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HAD depression score (HAD-D)", "code": "HADS_D", "days": [ 1, 2, 3 ], "primary": true } ], "pain_measures": [ { "measure": "VAS 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": "Bolus given 5 min before incision, described after induction and intubation (first mention says '5 min before operation'); PCIA holds no ketamine. Colorectal surgery with >10 cm incision, so the bolus was well before the last 30 min." }, { "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, "pump_total_mg": null, "dose_note": "0.6 mg/kg IV over at least 30 min in PACU once stable and awake", "start": "after_emergence", "end": "after_emergence" }, { "name": "Control Group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "robotic endometriosis removal surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "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 1 participant enrolled. Ketamine given awake in PACU after surgery. Anesthesia type not stated; robotic surgery with recovery to 'awake' in PACU implies general. Single masking (participant). Country from the NYULH mention." }, { "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": "1 mg/kg 15 min after induction, then 0.2 mg/kg/h (max 20 mg/h) continued until 48 h after fascial closure", "start": "after_induction", "end": "after_emergence" }, { "name": "Placebo Group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "spine surgery in opioid-dependent patients with chronic back pain", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PROMIS Emotional Distress-Depression Short Form", "code": "OTHER", "days": [ 14, 42 ], "primary": false } ], "pain_measures": [ { "measure": "hydromorphone PCA use over 72 h", "code": "opioid", "days": [ 3 ], "primary": true }, { "measure": "VAS pain (average to 72 h)", "code": "other", "days": [ 0, 1, 2, 3 ], "primary": true }, { "measure": "opioid utilization (records)", "code": "opioid", "days": [ 3, 42 ], "primary": true }, { "measure": "Pain Catastrophizing Scale", "code": "other", "days": [ 14, 42 ], "primary": false }, { "measure": "cold-pressor pain test", "code": "other", "days": [ 42 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "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 1 enrolled. Infusion continued 48 h after surgery while awake (coded pump). PROMIS depression visit is POD 10-14 (coded 14). Masking lists participant, care provider, investigator, not outcome assessor. Age limits not stated." }, { "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 (Group A): labor analgesia combined 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 in 100 mL epidural solution; 2 mL/h background + 8 mL PIEB hourly + PCEA (30 min lockout), until delivery", "start": "during_labor", "end": "end_of_surgery" }, { "name": "Experimental Group B (Group B): labor analgesia alone", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "labor epidural analgesia for spontaneous vaginal delivery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 1, 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "VAS pain", "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": "Open label. Group B (epidural without esketamine) is the inert control; Group C has no labor analgesia, so other. Esketamine given epidurally to awake laboring women until delivery (end coded end_of_surgery = end of delivery). Pump programs differ slightly between A and B. Assessors were not involved in care; masking not stated. Registered retrospectively." }, { "id": "T040", "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": "0.5 mg/kg in 40 mL infused over 40 min, started after induction and incision during maintenance GA", "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": "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": "Brief Pain Inventory short form", "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 given entirely during maintenance GA, begun after incision; surgery length not stated, so whether the 40-min infusion ended more than 30 min before the end of surgery is unclear. HADS reported as total; its timing not stated. No adverse-event recording described. Pre-registration mentioned without registry or ID." }, { "id": "T041", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E (esketamine)", "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; 2 mg/kg in 100 mL PCIA (sufentanil, flurbiprofen, tropisetron) over 48 h, 2 mL/h + 2 mL demand", "start": "after_induction", "end": "after_emergence" }, { "name": "Group C (saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "cancer surgery (orthopedic, urologic, major abdominal) in older patients", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HAMD-17", "code": "HAMD", "days": [], "primary": false } ], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "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": "Esketamine also in the postoperative PCIA for 48 h, so conscious dosing. HAMD-17 timing not stated (secondary: incidence of postoperative depressive symptoms). Patient blinding not stated; anesthesiologists doing follow-up blinded." }, { "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 PCIA with sufentanil 2 ug/kg + tropisetron 10 mg; 2 mL/h + 1 mL demand, 48 h", "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 section under spinal anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 42 ], "primary": true } ], "pain_measures": [ { "measure": "cumulative sufentanil consumption", "code": "opioid", "days": [ 1, 2 ], "primary": false }, { "measure": "NRS at rest", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "NRS on movement", "code": "movement", "days": [ 0, 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 right after skin closure under spinal anesthesia (plus TAP block), so given awake. Enrollment end stated as 'September 31, 2023'." }, { "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, "pump_total_mg": null, "dose_note": "0.2 mg/kg in 20 mL pumped over 40 min from the start of surgery (before delivery)", "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": "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": "Infused to awake parturients under CSEA from the start of surgery (start coded after_induction = after the neuraxial block). No outcome labelled primary; sample size based on PPD, so EPDS coded primary. Anesthesiologists not blinded." }, { "id": "T044", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E (esketamine)", "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 dose after fetal delivery; labor epidural stopped at delivery", "start": "after_delivery", "end": "end_of_surgery" }, { "name": "Group C (normal saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "labor epidural analgesia and vaginal delivery in primiparas", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "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 given to awake women right after fetal delivery under labor epidural (end coded end_of_surgery = end of delivery)." }, { "id": "T045", "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": false, "pump_total_mg": null, "dose_note": "perioperative infusion; dose and timing not stated", "start": "unclear", "end": "unclear" }, { "name": "Normal saline group", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PPD risk)", "code": "EPDS", "days": [], "primary": true } ], "pain_measures": [ { "measure": "postoperative pain intensity", "code": "other", "days": [], "primary": false }, { "measure": "cumulative sufentanil consumption", "code": "opioid", "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": "Abstract only: dose, timing and anesthesia not given; 150 randomized." }, { "id": "T046", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "High-dose 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": "initial IV infusion 0.25 mg/kg, then 2 mg/kg via PCIA with sufentanil 2.2 ug/kg", "start": "unclear", "end": "after_emergence" }, { "name": "Low-dose 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": "initial IV infusion 0.25 mg/kg, then 1 mg/kg via PCIA with sufentanil 2.2 ug/kg", "start": "unclear", "end": "after_emergence" }, { "name": "Placebo group (0.9% saline)", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section in women with prenatal depression", "depression_selection": "selected", "selection_criterion": "evidence of prenatal depression", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "postoperative analgesia", "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": "Abstract: esketamine in the postoperative PCIA, so conscious dosing whatever the unstated anesthesia and timing of the initial infusion." }, { "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, "pump_total_mg": null, "dose_note": "0.1 mg/kg after induction drugs, before intubation, then 0.1 mg/kg/h until the end of surgery", "start": "at_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": "laparoscopic radical resection for colorectal cancer", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [], "pain_measures": [ { "measure": "NRS", "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 outcome is fatigue (ICFS). GA plus TAP block. Adverse reactions recorded but none named." }, { "id": "T048", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "S-ketamine 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": "single dose after induction; route not stated", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Control group (normal saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "breast or thyroid surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [], "pain_measures": [ { "measure": "VAS pain", "code": "other", "days": [ 1, 2, 3 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "single", "note": "Abstract: outcomes are VAS pain and SAS anxiety only, no depression measure." }, { "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": "0.1 mg/kg ~3 min before incision, 0.1 mg/kg/h to end of surgery, then 1 mg/kg in 100 mL PCIA (0.015 mg/kg/h) for 48 h", "start": "after_induction", "end": "after_emergence" }, { "name": "Normal saline group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "thoracoscopic lung cancer surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "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": "sufentanil consumption", "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": "Esketamine continued in the postoperative PCIA for 48 h, so conscious dosing. BDI-II also at hospital discharge (day not fixed); primary at 1 month. Registry ID not given." }, { "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, "pump_total_mg": null, "dose_note": "single 0.6 mg/kg infused over ~45 min in PACU once medically stable", "start": "after_emergence", "end": "after_emergence" }, { "name": "Placebo group (0.9% saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "mastectomy with immediate reconstruction for cancer", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-2", "code": "PHQ9", "days": [], "primary": false } ], "pain_measures": [ { "measure": "BPI pain severity subscale", "code": "other", "days": [ 0, 1, 2, 7 ], "primary": true }, { "measure": "opioid usage", "code": "opioid", "days": [], "primary": false }, { "measure": "Breast Cancer Pain Questionnaire", "code": "other", "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": "Ketamine given after general anesthesia, in PACU, awake. PHQ-2 timing is in a figure not provided. Registration date given as 05/04/2021 (read as US month/day)." }, { "id": "T051", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Propofol group", "role": "control" }, { "name": "Dezocine group", "role": "other" }, { "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": "dose and timing not stated", "start": "unclear", "end": "unclear" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "painless curettage for missed miscarriage", "depression_selection": "selected", "selection_criterion": "preoperative EPDS >=10", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 42 ], "primary": true } ], "pain_measures": [ { "measure": "VAS 1 h after operation", "code": "other", "days": [ 0 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "single", "note": "Abstract: propofol-based painless curettage (no airway management described), coded sedation; propofol group taken as the no-study-drug control and the dezocine arm as other. Esketamine dose, route and timing not stated; conscious dosing follows from sedation." }, { "id": "T052", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E (esketamine)", "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 in 100 mL saline IV within 10 min after the infant was delivered", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Group C (normal saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section in primiparas", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 7, 42 ], "primary": true }, { "measure": "clinical interview for PPD (DSM-IV)", "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 given awake under CSEA after delivery; PCIA without esketamine. No outcome labelled primary; sample size based on PPD at 6 weeks, so PPD measures coded primary." }, { "id": "T053", "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 bolus as the first drug of the induction sequence, followed by propofol 2 mg/kg", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group P (normal saline)", "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": "HAMD", "code": "HAMD", "days": [ 3, 7, 30 ], "primary": false } ], "pain_measures": [ { "measure": "NRS", "code": "other", "days": [ 0, 1, 2, 3, 7, 30 ], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": true }, "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 induction, immediately before propofol (participant possibly awake for seconds at injection); no later doses, so none and not late. Single-blind: recruiting/follow-up staff and analysts unaware; patient blinding not explicit. Named adverse reactions are not psychotomimetic." }, { "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 0.15 mg/kg/h until end of surgery; then 2 mg/kg in 150 mL PCIA with butorphanol (3 mL load, 3 mL/h)", "start": "unclear", "end": "after_emergence" }, { "name": "Group C (butorphanol)", "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": "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 CSEA, so the intraoperative infusion was given awake (start relative to delivery not stated), plus esketamine PCIA. Control got 5% glucose and the same PCIA without esketamine." }, { "id": "T055", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "S group (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 dose within 10 min after umbilical cord clamping", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "C group (saline)", "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": "PCIA effective presses at 48 h", "code": "other", "days": [ 2 ], "primary": false }, { "measure": "duration of adjuvant analgesic use", "code": "other", "days": [], "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 given awake under CSEA after cord clamping; TAP block and PCIA without esketamine. Two hospitals." }, { "id": "T056", "eligible": false, "exclusion_reason": "not_randomized", "timing_comparison": false, "arms": [ { "name": "Study group (esketamine + sufentanil)", "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 pump; 6 mL/h + 7 mL PCA, 30 min lockout", "start": "during_labor", "end": "unclear" }, { "name": "Control group (sufentanil 3 ug/kg epidural)", "role": "other" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "labor epidural analgesia in primiparas", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "SDS", "code": "SDS", "days": [], "primary": false } ], "pain_measures": [ { "measure": "VAS pain", "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 despite 'divided into two groups randomly'; ethics approval dated after the study period. Control epidural had more sufentanil (3 vs 2 ug/kg), so not an inert control either. SDS 'after delivery', day not given." }, { "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, "pump_total_mg": null, "dose_note": "single IV dose (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, "pump_total_mg": null, "dose_note": "single IV dose (10 mL) after fetal delivery", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Control group (normal saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean delivery under combined spinal-epidural anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS", "code": "EPDS", "days": [ 2, 7, 42 ], "primary": false } ], "pain_measures": [ { "measure": "VAS", "code": "other", "days": [ 0, 1, 2 ], "primary": true } ], "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 given awake under CSEA after delivery; PCIA without esketamine. Blinding sentence garbled (administering anesthesiologists blinded); participants and assessors not said. Country not stated." }, { "id": "T058", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group S (esketamine)", "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 2 ug/kg + tropisetron 5 mg; 1.5 mL/h + 1.5 mL demand, 48 h", "start": "postoperative", "end": "after_emergence" }, { "name": "Group C (control)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "elderly hip fracture surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "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; combined spinal-epidural anesthesia plus fascia iliaca block." }, { "id": "T059", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Treatment Arm", "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": "intraoperative esketamine (dose not stated) plus postoperative IV analgesia pump with esketamine", "start": "unclear", "end": "after_emergence" }, { "name": "Control Arm", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "surgery for severe or extensive burns", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "depression questionnaire (not named)", "code": "OTHER", "days": [], "primary": false } ], "pain_measures": [ { "measure": "subjective analgesic efficacy", "code": "other", "days": [ 28 ], "primary": true }, { "measure": "NPR at rest", "code": "rest", "days": [], "primary": false }, { "measure": "NPR during movement", "code": "movement", "days": [], "primary": false }, { "measure": "opioid consumption", "code": "opioid", "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": "multi", "note": "Abstract: esketamine continued in a postoperative pump, so conscious dosing. Depression questionnaire and its timing not named." }, { "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, "pump_total_mg": null, "dose_note": "single injection after preoxygenation, before induction; propofol infused right after at 240 mL/h", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Morning operation without esketamine (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, "pump_total_mg": null, "dose_note": "single injection after preoxygenation, before induction; propofol infused right after at 240 mL/h", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Afternoon operation without esketamine (saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "elective surgery under general anesthesia in older adults (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": null, "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 awake 'before induction', propofol then infused slowly, so conscious dosing. HAD reported as one score; subscales not specified." }, { "id": "T061", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group E (esketamine)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": 0.15, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "0.3 mg/kg/h from induction of sedation until tumescent infiltration, then 0.15 mg/kg/h; stopped 30 min before end of surgery", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Group C (saline)", "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-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": "Esketamine infused during IV sedation (target MOAA/S ~3, spontaneous breathing), so given while responsive." }, { "id": "T062", "eligible": false, "exclusion_reason": "no_depression_measure", "timing_comparison": false, "arms": [ { "name": "S-ketamine group (S)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 1.5, "infusion_mg_per_kg_h": 2.0, "infusion_hours": null, "pump": false, "pump_total_mg": null, "dose_note": "timing and duration not stated", "start": "unclear", "end": "unclear" }, { "name": "Control group (C)", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "breast surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [], "pain_measures": [ { "measure": "chronic postsurgical pain NRS", "code": "other", "days": [ 90 ], "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": "Abstract names only the primary outcome (chronic pain at 3 months); no depression measure." }, { "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, "pump_total_mg": null, "dose_note": "0.2 mg/kg in 20 mL infused over 40 min (30 mL/h) after umbilical cord clamping", "start": "after_delivery", "end": "unclear" }, { "name": "Placebo group (normal saline)", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "vaginal_delivery", "procedure": "childbirth (vaginal or cesarean delivery) in women with prenatal depressive symptoms", "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": "pain NRS", "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": "Mixed deliveries: vaginal (with or without labor epidural) or cesarean under neuraxial anesthesia; no general anesthesia, so the infusion after cord clamping was given awake. Setting coded vaginal_delivery for a mixed sample. Five centres." }, { "id": "T064", "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, "pump_total_mg": null, "dose_note": "single preoperative IV bolus; timing relative to induction not stated", "start": "unclear", "end": "before_end_of_surgery" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": false, "setting": "surgery", "procedure": "major orthopedic surgery in patients aged 60 or over", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "symptoms of depression (scale not named)", "code": "OTHER", "days": [ 7, 90 ], "primary": false } ], "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": "multi", "note": "Abstract: 'preoperative' bolus, not said whether before or after induction, and anesthesia not stated; a preoperative single bolus is not late." }, { "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, "dose_note": "single 0.2 mg/kg IV infusion; infusion length not stated", "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": "Patient Health Questionnaire-9 (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 esketamine dose infused after induction of general anesthesia, so none conscious; length of the infusion not stated but given once at the start of a mastectomy, so coded as ending well before the end of surgery (late_dosing false). Psychotomimetic: only postoperative delirium recorded. Pain VAS not specified as rest or movement. Ethics approval and registration not stated in this text." }, { "id": "T066", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Lidocaine group (Group L)", "role": "other" }, { "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, "dose_note": "0.25 mg/kg bolus 10 min before induction, then 0.25 mg/kg/h until 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 at 1, 2, 6, 12, 24, 48 h after surgery", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "perioperative use of opioids", "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": "Esketamine bolus 10 min before induction (conscious), so some; infusion then ran until skin closure under GA (late_dosing true). Infusion duration not given (surgeries over 3 h excluded). Primary outcome QoR-40 on POD 2, SDS secondary. Patient and anesthesiologist blinded; outcome assessor not stated." }, { "id": "T067", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Low 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": "single injection during the operation; route not stated (injection, presumably IV); exact time not stated", "start": "after_induction", "end": "unclear" }, { "name": "High esketamine 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": "single injection during the operation; route not stated (injection, presumably IV); exact time not stated", "start": "after_induction", "end": "unclear" }, { "name": "Placebo", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "elective non-cardiac thoracic surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D", "code": "HADS_D", "days": [ 1, 3 ], "primary": false } ], "pain_measures": [ { "measure": "Pain VAS", "code": "other", "days": [ 1, 3 ], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "single", "note": "Abstract only. Single esketamine dose 'during the operation' under general anesthesia, so none conscious; when during surgery it was given is not stated, so end unclear and late_dosing null. Psychotomimetic: only delirium (CAM) assessed. 'Double blinded' not further specified. No primary outcome named." }, { "id": "T068", "eligible": false, "exclusion_reason": "no_inert_control", "timing_comparison": false, "arms": [ { "name": "Esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.7, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "0.7 mg/kg IV infused over 60 min; timing relative to surgery not stated", "start": "unclear", "end": "unclear" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "perioperative care of women with systemic tumors (procedure not stated)", "depression_selection": "selected", "selection_criterion": "perioperative anxiety and depression syndrome (PADS)", "age_group": null, "depression_measures": [ { "measure": "EEG-based SVM-KNN classifier of anxiety and depression status", "code": "OTHER", "days": [], "primary": false } ], "pain_measures": [], "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": "Abstract of an EEG machine-learning analysis. Called 'randomized, placebo-controlled', but all 112 included patients received esketamine and the comparison described is depressed vs non-depressed patients' EEG, so no inert control arm is shown. Also no timing relative to surgery and no depression scale after the procedure is described." }, { "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, "dose_note": "0.25 mg/kg IV with midazolam 2 mg right after delivery; PCIA 50 mg esketamine + 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", "pump_total_mg": 50 }, { "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 at rest, 12-72 h after surgery", "code": "rest", "days": [ 0, 1, 2, 3 ], "primary": false }, { "measure": "NRS during movement, 12-72 h after surgery", "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 cesarean, awake: esketamine bolus after delivery plus 48 h PCIA, so some. Both arms got midazolam 2 mg. Planned 150 per arm (128 computed). Two campuses of one hospital, coded single." }, { "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": null, "pump": true, "dose_note": "IV analgesia pump only: esketamine '0.75 mcg/mL' with sufentanil 1.5 mcg/mL in 100 mL, '0.05 mcg/kg/h' for 24 h after surgery (units as printed; arithmetic implies mg)", "start": "postoperative", "end": "after_emergence", "pump_total_mg": null }, { "name": "Control group", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "VATS lung resection", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Patient Health Questionnaire-9 (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 postoperative continuous IV analgesia pump, started after surgery and an erector spinae block and run 24 h, so some. Primary outcome low minute ventilation; PHQ-9 secondary. Adverse events listed are not psychiatric. Country not stated." }, { "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, "dose_note": "0.5 mg/kg over 10 min then 0.3 mg/kg/h for 3 h in PACU (8 h in ICU before the 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 neuro, vascular, cardiac)", "depression_selection": "selected", "selection_criterion": "history of depression (EHR diagnosis or home antidepressant)", "age_group": "adult", "depression_measures": [ { "measure": "Montgomery-Asberg Depression Rating Scale (MADRS)", "code": "MADRS", "days": [ 1, 2, 4, 7, 14 ], "primary": false } ], "pain_measures": [ { "measure": "VAS and NRS pain at rest", "code": "rest", "days": [ 1, 2, 4, 7, 14 ], "primary": false }, { "measure": "VAS and NRS pain with movement and on deep breath or cough", "code": "movement", "days": [ 1, 2, 4, 7, 14 ], "primary": false }, { "measure": "total opioid dose (oral morphine equivalents) to 07:00 on post-infusion day 2", "code": "opioid", "days": [ 0, 1, 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": "Randomized after surgery and extubation; ketamine began in the OR immediately after extubation and ran 3 h (8 h originally), so all dosing awake: some. Feasibility trial: primary outcomes are feasibility; MADRS change to day 4 is the pre-specified primary depression measure, not the trial's primary outcome. Days are post-infusion days." }, { "id": "T072", "eligible": true, "exclusion_reason": null, "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, "dose_note": "intraoperative IV infusion 0.15 mg/kg/h (start and stop not stated); PCIA esketamine 2 mg/kg + butorphanol 0.2 mg/kg in 150 mL, 3 mL load, 3 mL/h background, 3 mL bolus, 15 min lockout", "start": "unclear", "end": "after_emergence", "pump_total_mg": null }, { "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": "number of PCIA (butorphanol) presses in 24 h", "code": "opioid", "days": [ 0, 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": "Combined spinal-epidural cesarean, awake; intraoperative esketamine infusion then esketamine in the PCIA, so some. Control got 5% glucose intraoperatively and the same PCIA without esketamine. EPDS at 8 h, 24 h, 96 h and 1 week coded days 0, 1, 4, 7. 'Double-blind' not specified." }, { "id": "T073", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Epidural saline + IV saline", "role": "other" }, { "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, "dose_note": "single 0.3 mg/kg IV infusion with epidural morphine 3 mg; time 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 only. Ketamine arm (with epidural morphine) is compared with epidural morphine + IV saline, the inert control; the double-saline arm lacks morphine, so coded other. Women had OASIS after vaginal delivery with a working labor epidural, so ketamine was given after delivery while awake: some; exact time not stated. Actual enrollment 67; planned n not given." }, { "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, "dose_note": "0.5 mg/kg IV over about 1 min right after cord clamping; PCIA with esketamine 0.5 mg/kg + sufentanil 4 ug/kg in 200 mL from the end of surgery, 2 mL/h background, 3 mL bolus, 15 min lockout", "start": "after_delivery", "end": "after_emergence", "pump_total_mg": null }, { "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 score within 24 h", "code": "other", "days": [ 0, 1 ], "primary": true }, { "measure": "NRS moving incision pain, 0-24 h", "code": "movement", "days": [ 0, 1 ], "primary": false }, { "measure": "NRS rest incision pain, 0-24 h", "code": "rest", "days": [ 0, 1 ], "primary": false }, { "measure": "NRS visceral pain, 0-24 h", "code": "other", "days": [ 0, 1 ], "primary": false }, { "measure": "PCIA presses, rescue analgesics and total PCIA drug consumption, 0-24 h", "code": "opioid", "days": [ 0, 1 ], "primary": false }, { "measure": "pressure pain threshold and tolerance at 30 min and 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 cesarean, awake: esketamine bolus after cord clamping plus esketamine in the PCIA, so some. Depression (EPDS) on POD 2 is secondary." }, { "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, "dose_note": "0.25 mg/kg bolus right after the induction drugs, before intubation; 0.25 mg/kg/h maintenance, 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": "elderly 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": "NRS >= 4 on coughing on POD1 (moderate-to-severe pain)", "code": "movement", "days": [ 1 ], "primary": true }, { "measure": "NRS during coughing at 4 h, 8 h, POD1, POD3", "code": "movement", "days": [ 0, 1, 3 ], "primary": false }, { "measure": "NRS at rest at 4 h, 8 h, POD1, POD3", "code": "rest", "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 }, { "measure": "24 h pain AUC and pain intensity-opioid consumption (exploratory)", "code": "other", "days": [ 0, 1 ], "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": "Bolus given right after the induction drugs (unconscious), infusion under GA stopped 15 min before the end of surgery, so none; the infusion ran into the last 30 min, so late_dosing true. 114 calculated, 136 enrolled to allow for dropouts." }, { "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, "dose_note": "0.25 mg/kg IV with sufentanil 0.1 ug/kg before skin incision; PCIA from 10 min before the end of surgery with esketamine 1 mg/kg + sufentanil 2 ug/kg in 100 mL, 2 mL first dose, 2 mL/h background, 1 mL bolus, 10 min lockout", "start": "after_induction", "end": "after_emergence", "pump_total_mg": null }, { "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, "dose_note": "0.5 mg/kg IV with sufentanil 0.1 ug/kg before skin incision; PCIA from 10 min before the end of surgery with esketamine 1 mg/kg + sufentanil 2 ug/kg in 100 mL, 2 mL first dose, 2 mL/h background, 1 mL bolus, 10 min lockout", "start": "after_induction", "end": "after_emergence", "pump_total_mg": null } ], "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 at 1, 6, 12, 24, 48 h after surgery", "code": "other", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "PCIA button presses over 48 h", "code": "opioid", "days": [ 0, 1, 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": "Esketamine bolus under GA before incision, then esketamine in the PCIA connected 10 min before the end of surgery (first dose under GA, so late_dosing true) and run after waking, so some. Control (S1) got the same sufentanil and PCIA without esketamine, no placebo named. Enrollment required HAM-D 8-20." }, { "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, "dose_note": "0.2 mg/kg during induction, after anesthetic depth was set; 0.4 mg/kg/h 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 at 24 and 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; esketamine bolus during induction after the anesthetic depth was adjusted, then infusion until the end of surgery, so none conscious with late_dosing true. Primary outcome postoperative sleep disturbance (PSQI); SDS secondary. No psychiatric adverse events named." }, { "id": "T078", "eligible": false, "exclusion_reason": "no_inert_control", "timing_comparison": false, "arms": [ { "name": "Control group", "role": "other" }, { "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, "dose_note": "0.3 mg/kg IV with fentanyl 0.5 ug/kg 1 min after remimazolam (control got fentanyl 1.5 ug/kg instead)", "start": "at_induction", "end": "before_end_of_surgery" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "elderly 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": "Esketamine replaces part of the opioid: the control got fentanyl 1.5 ug/kg, the esketamine arm fentanyl 0.5 ug/kg, so no inert control. Also no depression measure (only QoR-15 recovery quality). Dosed under remimazolam sedation, so some." }, { "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, "dose_note": "0.3 mg/kg/h infusion throughout surgery during maintenance, no bolus", "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; sample size from laparoscopy data)", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [], "pain_measures": [ { "measure": "VAS at several times within 72 h", "code": "other", "days": [ 0, 1, 2, 3 ], "primary": false }, { "measure": "intraoperative propofol and 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 was taken only 24 h before surgery as a baseline; outcomes after surgery are sleep (AIS), pain and adverse events, so no postoperative depression measure. Infusion ran throughout surgery under GA (anesthetics stopped at closure): none, late_dosing true." }, { "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, "dose_note": "separate esketamine pump: 0.5 mg/kg in 48 mL at 2 mL/h for 24 h from immediately after surgery", "start": "end_of_surgery", "end": "after_emergence", "pump_total_mg": null }, { "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, "dose_note": "separate esketamine pump: 0.75 mg/kg in 48 mL at 2 mL/h for 24 h from immediately after surgery", "start": "end_of_surgery", "end": "after_emergence", "pump_total_mg": null }, { "name": "Control group (C)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "lower limb fracture surgery", "depression_selection": "selected", "selection_criterion": "HAMD-17 >= 7 at admission, no prior MDD 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": [ 0, 1, 2 ], "primary": true }, { "measure": "VAS at 4, 8, 12, 24, 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "PCA compressions", "code": "opioid", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "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 given only by a dedicated continuous pump started immediately after surgery and run 24 h, mostly while awake, so some; rates are 0.5 or 0.75 mg/kg over 24 h. Saline pump in control. Enrollment required HAMD-17 >= 7." }, { "id": "T081", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.3, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "single IV dose at anesthesia induction", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Saline", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "cardiac valve surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": null, "depression_measures": [ { "measure": "HADS (prevalence of depression)", "code": "HADS_D", "days": [ 7 ], "primary": true } ], "pain_measures": [ { "measure": "pain scores", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "multi", "note": "Abstract only. One esketamine dose at induction of anesthesia for valve surgery, nothing later, so none and late_dosing false (whether given just before loss of consciousness is not stated). Psychotomimetic: only delirium incidence. 142 randomized; planned n not stated." }, { "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, "dose_note": "PCIA only, from after cord clamping: esketamine 0.5 mg/kg + sufentanil 2 ug/kg in 100 mL, 2 mL/h background (about 0.01 mg/kg/h), 2 mL bolus, 15 min lockout", "start": "after_delivery", "end": "after_emergence", "pump_total_mg": null }, { "name": "Esketamine-dexmedetomidine (Group ED)", "role": "other" } ], "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": "HADS (depression level)", "code": "HADS_D", "days": [ 2 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest at 6, 12, 24, 48, 72 h", "code": "rest", "days": [ 0, 1, 2, 3 ], "primary": false }, { "measure": "NRS during movement at 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": "frequency of rescue analgesia (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 cesarean, awake; esketamine only in the PCIA started after cord clamping, so some. Control has the same PCIA without esketamine (no placebo named). The ED arm adds dexmedetomidine. HADS on POD 2 is secondary; primary is sleep (RCSQ). Adverse events include dizziness." }, { "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, "dose_note": "0.5 mg/kg after loss of consciousness at induction; 0.25 mg/kg/h during maintenance, 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": "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": "Bolus after loss of consciousness, infusion under GA stopped with sevoflurane just before skin suturing, so none; it ran into the last minutes of surgery, so late_dosing true. HAMD-17 primary at POD 30." }, { "id": "T084", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "S-ketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.4, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "0.4 mg/kg; route and timing relative to surgery not stated in the abstract", "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 (50% response on POD1; severity trajectories over 7 days)", "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: when S-ketamine was given relative to surgery, its route, and the anesthesia are not stated, so conscious_dosing unclear. Only unspecified 'adverse events' named. Depression severity followed over postoperative days 1-7 (exact days not given). 230 enrolled; planned n not stated." }, { "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, "dose_note": "0.25 mg/kg/h from after induction until abdomen closure, no bolus", "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 defines depressive symptoms)", "code": "PHQ9", "days": [ 7 ], "primary": false } ], "pain_measures": [ { "measure": "pain NRS at designated time points", "code": "other", "days": [], "primary": false }, { "measure": "morphine consumption (PACU rescue + PCA) in first 24 h", "code": "opioid", "days": [ 0, 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": "GA plus TAP block after induction; esketamine infusion only under GA from after induction until abdomen closure, so none with late_dosing true. Primary QoR-40 at 24 h; PHQ-9 on POD 7 secondary." }, { "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, "dose_note": "single 0.25 mg/kg IV within 10 min after fetal removal; no esketamine in the PCIA", "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 spinal anesthesia", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PPD incidence, score >= 10)", "code": "EPDS", "days": [], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest at 4, 8, 12, 24, 48 h", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "NRS during movement at 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 cesarean, awake: single esketamine dose after delivery, so some. The postoperative day of the EPDS is not stated (the sample size uses day-3 incidence), so days left empty. SDS was taken only before surgery." }, { "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." }, { "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, "dose_note": "0.25 mg/kg IV (10 mL at 200 mL/h) after cord cutting; PCIA from the end of surgery with esketamine 1 mg/kg + sufentanil 1.5 ug/kg + nalbuphine 0.5 mg/kg in 100 mL, 2 mL/h background, 0.5 mL bolus, 15 min lockout, about 48 h", "start": "after_delivery", "end": "after_emergence", "pump_total_mg": null }, { "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, "dose_note": "0.25 mg/kg IV (10 mL at 200 mL/h) after 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 at 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 cesarean, awake: both esketamine arms got a bolus after delivery and group A also esketamine in the PCIA, so some. Primary: EPDS decline at days 3, 5, 7; EPDS also at 14, 30, 42. The text given also carries the abstract's results and an introduction, which were ignored." }, { "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, "dose_note": "0.25 mg/kg IV push at induction, then 0.125 mg/kg/h until 20 min before the end of surgery; no esketamine in the postoperative pump", "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 elderly 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 at 24 and 48 h", "code": "rest", "days": [ 1, 2 ], "primary": false }, { "measure": "NRS on coughing at 24 and 48 h", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "intraoperative anesthetic drug consumption", "code": "opioid", "days": [ 0 ], "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. GA plus erector spinae block; esketamine bolus at induction and infusion under GA stopped 20 min before the end of surgery, so none; the infusion ran into the last 30 min, so late_dosing true. Enrollment limited to ages 65-80 with FRAIL >= 3. No registration stated." }, { "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, "dose_note": "0.15 mg/kg IV with the induction agents; maintenance esketamine (rate not stated) stopped 30 min before the end of surgery (one sentence says at skin closure)", "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, "dose_note": "0.25 mg/kg IV with the induction agents; maintenance esketamine (rate not stated) stopped 30 min before the end of surgery (one sentence says at skin closure)", "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, "dose_note": "0.35 mg/kg IV with the induction agents; maintenance esketamine (rate not stated) stopped 30 min before the end of surgery (one sentence says at skin closure)", "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 at 3, 6, 12, 24, 48 h", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "NRS during exercise at 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": "Esketamine given with the induction agents and continued under GA until 30 min before the end of surgery (said twice), so none and late_dosing false; one sentence also lists esketamine among agents stopped at skin closure, which would make it late. Postoperative HADS day not stated. Called multicenter but all patients came from one hospital department, so coded single. Single-blind, party not stated." }, { "id": "T091", "eligible": false, "exclusion_reason": "no_inert_control", "timing_comparison": false, "arms": [ { "name": "Control group", "role": "other" }, { "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, "dose_note": "postoperative IV analgesia over 48 h from the end of surgery: esketamine 2 mg/kg + sufentanil 2.0 ug/kg (control: sufentanil 2.5 ug/kg)", "start": "end_of_surgery", "end": "after_emergence", "pump_total_mg": null } ], "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": "PCIA presses", "code": "opioid", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "VAS at 4, 8, 24, 48 h", "code": "other", "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": "Esketamine replaces part of the opioid: the control's postoperative infusion had sufentanil 2.5 ug/kg, the esketamine arm's 2.0 ug/kg plus esketamine, so no inert control with otherwise the same care. Esketamine given only in the 48 h postoperative analgesia, so some. 104 patients selected; no planned n." }, { "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, "dose_note": "single 0.5 mg/kg IV during the induction period of GA", "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 (women)", "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 esketamine dose during induction of GA, nothing later, so none; given at the start of thyroid cancer surgery, so late_dosing false. SDS on the day after surgery is a main indicator and drove the sample size. Only 'anesthesia-related complications' named. The blinded anesthesiologist also assessed outcomes; patient blinding not stated." }, { "id": "T093", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "0.25 mg/kg IV over the initial 40 min of anesthesia", "start": "at_induction", "end": "before_end_of_surgery" }, { "name": "Saline placebo", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "none", "late_dosing": null, "setting": "surgery", "procedure": "elective breast cancer surgery", "depression_selection": "selected", "selection_criterion": "MADRS >= 12 preoperatively", "age_group": "adult", "depression_measures": [ { "measure": "Montgomery-Asberg Depression Rating Scale (MADRS)", "code": "MADRS", "days": [ 1, 2, 3 ], "primary": true } ], "pain_measures": [ { "measure": "postoperative severe pain", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "single", "note": "Abstract only. Esketamine infused over the first 40 min of anesthesia (GA implied, not named), so none; surgery length not stated, so whether it ended more than 30 min before the end is unclear (late_dosing null). MADRS response 'within 3 postoperative days', exact days not given. Only unspecified adverse events monitored for 72 h." }, { "id": "T094", "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, "dose_note": "0.3 mg/kg/h from 10 min before induction until the end of surgery, no bolus", "start": "before_induction", "end": "end_of_surgery" }, { "name": "Control group (normal saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "elderly 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 at 24 and 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 until the end of surgery (late_dosing true). Primary outcome sleep disturbance; HADS-D secondary. 174 planned, 200 enrolled." }, { "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, "dose_note": "0.25 mg/kg in 20 mL saline IV over 20 min after fetal delivery; no esketamine in the PCIA", "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 neuraxial anesthesia", "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 on POD 1-3", "code": "rest", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "NRS with movement on POD 1-3", "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": "Epidural, spinal or combined anesthesia (some also a TAP or QL block), awake: esketamine infused over 20 min after delivery, so some. EPDS primary at 6 weeks, also 1 week. Adverse events came from an open-ended question about discomfort, no psychiatric effects named. Ages not stated. No registration stated in this text." }, { "id": "T096", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Oral ketamine", "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 orally, nine doses over three days or until discharge; first dose's timing relative to surgery not stated", "start": "unclear", "end": "after_emergence" }, { "name": "Matching placebo", "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 (mood)", "code": "PHQ9", "days": [], "primary": false } ], "pain_measures": [ { "measure": "opioid use", "code": "opioid", "days": [], "primary": false }, { "measure": "pain intensity", "code": "other", "days": [], "primary": false }, { "measure": "PROMIS pain interference", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": false, "blinding": { "participants": true, "assessors": null }, "registration": null, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": "Canada", "centers": "single", "note": "Abstract only. Oral ketamine taken over three days around spine surgery, necessarily while awake, so some; anesthesia and PHQ-9 days not stated. Side effects by a generic scale (GASE), no psychiatric effects named. Feasibility trial with QoR-15 primary." }, { "id": "T097", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Post-ESK", "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 infused within 10 min after induction (adjusted body weight)", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Pre-ESK", "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 infused 2 h before induction (adjusted body weight)", "start": "before_induction", "end": "before_end_of_surgery" }, { "name": "Placebo", "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 (rest/movement not stated)", "code": "other", "days": [ 1, 2 ], "primary": false }, { "measure": "PCA pump presses (analgesic demand)", "code": "other", "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 dosed awake 2 h before induction, so the ketamine arms together are 'some'. Post-ESK alone would be 'none' (single dose within 10 min after induction), late_dosing false. TAP block given in PACU after surgery. 120 randomized (3 x 40); no planned size or calculation given." }, { "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/d + sufentanil 1 ug/kg/d in 100 mL, 2 mL/h background, 2 mL bolus, 15 min lockout", "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 within 24 h", "code": "rest", "days": [ 0, 1 ], "primary": true }, { "measure": "VAS on cough within 24 h", "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 named (pain primary, side effects incl. nightmares secondary). Esketamine only in the postoperative PCIA pump started at the end of a spinal cesarean, so conscious dosing. Control gets the same sufentanil PCIA." }, { "id": "T099", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "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 immediately after the beginning of surgery", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Saline", "role": "control" } ], "anesthesia": "sedation", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "elective first-trimester surgical abortion", "depression_selection": "unselected", "selection_criterion": "poor sleep (PSQI > 5), not depression", "age_group": "adult", "depression_measures": [ { "measure": "HADS depression subscale (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": "patients taking acetaminophen", "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 titrated to MOAA/S <= 2 and BIS 45-60 with spontaneous breathing via nasal cannula, no airway device: coded sedation, so 'some' by the codebook. Dose given at the start of a short procedure; if this deep sedation were counted as general anesthesia, it would be 'none' with late_dosing true. Primary outcome is insomnia (AIS)." }, { "id": "T100", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group (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; then PCIA esketamine 1 mg/kg + sufentanil 2 ug/kg in 100 mL (2 mL initial, 1.5 mL/h, 2 mL bolus, 15 min lockout) for 48 h", "start": "at_induction", "end": "after_emergence" }, { "name": "Control group (placebo group, group C)", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "laparoscopic radical resection for 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 (rest/movement not stated) at emergence, 6, 12, 24, 48 h", "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 bolus at induction plus a 48 h postoperative PCIA pump with esketamine, so 'some'. When the pump (with its 2 mL initial dose) started is not stated, so late_dosing null. Both groups had a TAP block. Primary outcome is HADS-A (anxiety) on day 1." }, { "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 before incision, 0.1 mg/kg/h until end of operation; PCIA esketamine 1 mg/kg + sufentanil 3 ug/kg in 150 mL (2 mL/h, 2 mL bolus, 10 min lockout) for 72 h, started in OR at completion 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 (rest/movement not stated), PACU and POD1-3", "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": "Esketamine continued after surgery in the 72 h PCIA pump, so 'some'; the intraoperative infusion also ran to the end of surgery (late true). All patients had a TAP block before induction. Enrolled anxious patients (HAMA > 7); primary outcome HAMA response. Only nausea/vomiting named as adverse events." }, { "id": "T102", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine experimental group", "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": "1 mg/mL at 0.3 mL/kg/h as part of TIVA maintenance after fetal 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 (rest/movement not stated) at 24, 48, 72 h", "code": "other", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "rescue analgesia rate within 72 h", "code": "other", "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": "Esketamine infused with propofol/remifentanil TIVA after delivery under GA with LMA and ventilation, 'throughout the entire surgical procedure', so 'none' with late_dosing true (run until the end). PCIA contents not stated and not said to contain esketamine. Fascial plane blocks given after surgery. Excluded EPDS >= 13 preoperatively." }, { "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, "dose_note": "0.25 mg/kg bolus before incision after induction, then 0.125 mg/kg/h until skin closure; PCA pump hydromorphone only", "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": "elective McKeown esophagectomy for esophageal cancer", "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": "Bolus given 'before the incision', read as after induction (it is described after the sufentanil/propofol/cisatracurium induction, with parecoxib 10-15 min before incision); infusion until skin closure under sevoflurane GA, so 'none' with late_dosing true. PCA has no esketamine. Intercostal block given by the surgeon during surgery, TAP block in PACU. Primary outcome QoR-15." }, { "id": "T104", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "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, "dose_note": "loading dose started within 10 min before induction, then infusion until end of surgery", "start": "before_induction", "end": "end_of_surgery" }, { "name": "LA group (lidocaine + esketamine)", "role": "other" }, { "name": "L group (lidocaine)", "role": "other" }, { "name": "N group (saline)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "elective functional endoscopic sinus surgery for chronic rhinosinusitis", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "Zung Self-Rating Depression Scale (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 randomized 4-arm trial. Esketamine loading dose started within 10 min before induction (awake), infusion to the end of surgery, so 'some' (late_dosing also true). LA arm adds lidocaine, so 'other'. Parent sample size not given (140 analysed)." }, { "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, no bolus; PCIA from end of surgery with esketamine 1 mg/kg + sufentanil 1 ug/kg in 100 mL (2 mL/h, 0.5 mL bolus, 20 min lockout)", "start": "after_induction", "end": "after_emergence" }, { "name": "Placebo group", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "acoustic neuroma surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS-D (depression = HADS-D > 7)", "code": "HADS_D", "days": [ 1, 3 ], "primary": true } ], "pain_measures": [ { "measure": "VAS at rest within 48 h", "code": "rest", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "VAS during movement within 48 h", "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": "Intraoperative infusion ran only 1 h after induction, but the esketamine PCIA pump set up at the end of surgery dosed after waking, so 'some' (late_dosing true because the pump started at the end of surgery). Excluded HADS subscore > 10 or on medication." }, { "id": "T106", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Experimental group (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": "0.25 mg/kg at anesthesia induction and again 0.25 mg/kg at skin suture; PCIA hydromorphone only", "start": "at_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": "non-cardiac thoracic surgery", "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 on movement (coughing/deep breathing)", "code": "movement", "days": [ 0, 1, 3, 5 ], "primary": false }, { "measure": "hydromorphone intake", "code": "opioid", "days": [ 1, 2 ], "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 doses under GA with a double-lumen tube: one at induction, one at skin suture (end of surgery), so 'none' with late_dosing true. PCIA has no esketamine. Intercostal block before the end of the procedure. Poor sleepers only (PSQI >= 7). Participants coded blinded from 'double-blind' and assignments withheld until discharge." }, { "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, "dose_note": "0.25 mg/kg over 20 s immediately after delivery and cord clamping, then saline infusion over 20 min", "start": "after_delivery", "end": "before_end_of_surgery" }, { "name": "Infusion 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": "saline bolus, then 0.25 mg/kg infused over 20 min starting immediately after delivery", "start": "after_delivery", "end": "unclear" }, { "name": "Control group (saline)", "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 (PPD = EPDS > 10)", "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/walking)", "code": "movement", "days": [ 1, 2, 3 ], "primary": false }, { "measure": "PCIA (fentanyl) usage", "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": "Spinal cesarean, esketamine after cord clamping in awake women, so 'some'. Arms differ in rate (bolus vs 20 min infusion), with a saline arm, so eligible and not a timing comparison. Whether the 20 min infusion ended before closure isn't stated. Adverse events recorded only generically (open-ended question, definitions in a supplement), so monitoring coded false. Participants coded blinded from 'double-blinded' with double-dummy syringes." }, { "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, 10 min lockout), > 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 (primary: incidence of depression on POD3)", "code": "HAMD", "days": [ 1, 2, 3, 5 ], "primary": true } ], "pain_measures": [ { "measure": "VAS (rest/movement not stated), PACU and PODs 1, 2, 3, 5", "code": "other", "days": [ 0, 1, 2, 3, 5 ], "primary": false }, { "measure": "total postoperative sufentanil dose", "code": "opioid", "days": [], "primary": false }, { "measure": "PCIA presses, supplemental analgesia, rescue medication", "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 (no intraoperative dose), so 'some'; when the pump started isn't stated. Primary outcome is 'incidence of depression on POD3' with no instrument named; HAMD-17 is the only depression scale named (listed as secondary), so it is marked primary. Adverse events named only generically." }, { "id": "T109", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group (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 bolus at skin incision; PCA sufentanil only", "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": "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 (2, 4, 24, 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 after induction and intubation/LMA, so 'none'. Coded late false since the only dose was at incision, but surgical durations of these mixed procedures aren't stated. Some patients also had a nerve block before induction. HADS anxiety and depression named as primary outcomes (sample size on HADS-A POD3)." }, { "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 bolus during induction after midazolam/sufentanil; 48 h PCIA esketamine 1 mg/kg + sufentanil 1 ug/kg + tropisetron + flurbiprofen in 100 mL (2 mL/h, 2 mL bolus, 15 min lockout)", "start": "at_induction", "end": "after_emergence" }, { "name": "Control group", "role": "other" } ], "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 (PSQ)", "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 and rescue analgesia", "code": "other", "days": [ 0, 1, 2 ], "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": "Control got saline at induction but its PCIA had twice the sufentanil (2 vs 1 ug/kg) to compensate for esketamine, so its care is not otherwise the same: coded no_inert_control (borderline; otherwise eligible). Esketamine continued in the 48 h PCIA, so 'some'; the induction dose followed only midazolam 1 mg and sufentanil." }, { "id": "T111", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine group (Group E)", "role": "ketamine", "drug": "esketamine", "route": "iv", "bolus_mg_per_kg": 0.25, "infusion_mg_per_kg_h": 0.25, "infusion_hours": null, "pump": false, "dose_note": "after midazolam 0.05 mg/kg, 0.25 mg/kg over 10 min before induction, then 0.25 mg/kg/h until end of surgery", "start": "before_induction", "end": "end_of_surgery" }, { "name": "Magnesium sulfate group (Group M)", "role": "other" }, { "name": "Saline control group (Group C)", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "some", "late_dosing": true, "setting": "surgery", "procedure": "elective 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": "Self-rating Depression Scale (SDS)", "code": "SDS", "days": [ 1, 2 ], "primary": false } ], "pain_measures": [ { "measure": "VAS (rest/movement not stated) at 2, 4, 8, 24, 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "rescue analgesia (ketorolac) requirement", "code": "other", "days": [ 0 ], "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": "Esketamine bolus given over 10 min before induction (after midazolam 0.05 mg/kg, awake), then infused until the end of surgery: 'some', and late_dosing true. HADS scores named as the primary outcome (sample size on HADS-A); subscale use assumed from that." }, { "id": "T112", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine", "role": "ketamine", "drug": "esketamine", "route": null, "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "given intraoperatively; dose, route and timing not stated in the abstract", "start": "unclear", "end": "unclear" }, { "name": "Placebo", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "major surgery (multiple types)", "depression_selection": "selected", "selection_criterion": "moderate-to-severe perioperative depressive symptoms", "age_group": null, "depression_measures": [ { "measure": "MADRS (remission = MADRS <= 10)", "code": "MADRS", "days": [ 3 ], "primary": true } ], "pain_measures": [ { "measure": "pain (unspecified)", "code": "other", "days": [], "primary": false } ], "psychotomimetic_monitoring": true, "blinding": { "participants": true, "assessors": true }, "registration": { "registry": "ClinicalTrials.gov", "id": "NCT04425473", "date": null }, "enrollment": { "start": null, "end": null }, "ethics_approval": false, "planned_n": null, "country": null, "centers": "multi", "note": "Abstract only: 'esketamine or placebo intraoperatively' with no dose, route, anesthesia type or end time, so conscious_dosing unclear. Blinding from 'double-blinded'. Results in the abstract ignored; 435 randomized is not a planned n." }, { "id": "T113", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "ES1", "role": "ketamine", "drug": "esketamine", "route": null, "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "regimen given only in Table 1 (not provided); PCA settings in Table 2", "start": "unclear", "end": "unclear" }, { "name": "ES2", "role": "ketamine", "drug": "esketamine", "route": null, "bolus_mg_per_kg": null, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "regimen given only in Table 1 (not provided)", "start": "unclear", "end": "unclear" }, { "name": "C", "role": "control" } ], "anesthesia": "general", "conscious_dosing": "unclear", "late_dosing": null, "setting": "surgery", "procedure": "elective radical colorectal cancer surgery in older patients", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "HAMD", "code": "HAMD", "days": [ 1 ], "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": "Arms' regimens are only in tables not provided; ES1/ES2 read as two esketamine doses (esketamine allergy excluded, identical opaque bags) and C as the control, so eligible but dose, route and timing unknown: conscious_dosing unclear. HAMD postoperative timing only implied (24 h correlation with VAS); primary outcome not named." }, { "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, "dose_note": "bolus after induction, infusion stopped 30 min before the end of surgery; PCA sufentanil + nalbuphine only", "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 older patients with Parkinson's disease", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "Self-rating Depression Scale (SDS)", "code": "SDS", "days": [ 1, 3, 7 ], "primary": true } ], "pain_measures": [ { "measure": "VAS (rest/movement not stated) on POD1", "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": "Bolus after induction and intubation, infusion maintained only until 30 min before the end of surgery, so 'none' and late_dosing false. Adverse events recorded within 24 h, with dissociative symptoms named as the expected reactions. Excluded severe depression (SDS > 72) and antidepressant use." }, { "id": "T115", "eligible": false, "exclusion_reason": "not_randomized", "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": "0.5 mg/kg infused over 40 min, with or without general anesthesia", "start": "unclear", "end": "unclear" }, { "name": "Placebo", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "pooled cohorts: healthy volunteers, elective surgery patients, patients with depression", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [], "pain_measures": [], "psychotomimetic_monitoring": false, "blinding": { "participants": null, "assessors": null }, "registration": null, "enrollment": { "start": "2017", "end": "2023" }, "ethics_approval": false, "planned_n": null, "country": "USA; New Zealand", "centers": "multi", "note": "Described as a cohort study pooling participant-level data from 3 prospective studies; random allocation not stated. Outcome is EEG band power during infusion, no depression measure named, and participants include non-surgical volunteers. Some received ketamine without GA (awake), hence 'some'." }, { "id": "T116", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Study group (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 infused over 40 min by pump, starting immediately after delivery and cord ligation", "start": "after_delivery", "end": "unclear" }, { "name": "Control group (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, 24 h", "code": "rest", "days": [ 1 ], "primary": false }, { "measure": "VAS during movement, 24 h", "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": "Esketamine infused over 40 min after delivery in awake women under CSE, so 'some'; whether the infusion outlasted the surgery isn't stated. Single-blind: mothers unaware, anesthesiologists aware; assessors not mentioned. 136 enrolled and randomized, no planned size given. PCIA butorphanol only." }, { "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": null, "infusion_hours": null, "pump": false, "dose_note": "0.2-0.3 mg/kg by pump over 20 min immediately after induction and intubation; PCIA sufentanil only", "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 (response = >= 50% decrease)", "code": "MADRS", "days": [ 1, 2, 3 ], "primary": true }, { "measure": "PHQ-9", "code": "PHQ9", "days": [ 3 ], "primary": false } ], "pain_measures": [ { "measure": "NRS (rest/movement not stated) at 2 h, 4 h, POD1-3", "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 induction and intubation under GA, so 'none'; late false because dosing ended about 20 min into surgeries estimated at 30 min to 7 h (in the shortest it could overlap the last 30 min). Follow-ups at 2 weeks and 1 month by video are named for YMRS/BPRS/CADSS; whether PHQ-9/MADRS were repeated then is unclear." }, { "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." }, { "id": "T119", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Experimental group (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, "dose_note": "0.2 mg/kg during induction, then 0.1 mg/kg/h until the end of surgery", "start": "at_induction", "end": "end_of_surgery" }, { "name": "Control group (P group)", "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": "Dose given during induction and infusion until the end of surgery under sevoflurane GA with intubation, so 'none' with late_dosing true. Primary outcome PHQ-9 at POD30. Adverse events named only generically. No registration mentioned." }, { "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; 24 h PCIA esketamine 80 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", "role": "control" } ], "anesthesia": "neuraxial", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "elective cesarean section under combined spinal-epidural anesthesia (primiparae)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "EPDS (PPD = EPDS >= 10)", "code": "EPDS", "days": [ 7, 30, 60, 90 ], "primary": true } ], "pain_measures": [ { "measure": "NRS at rest within 24 h", "code": "rest", "days": [ 0, 1 ], "primary": false }, { "measure": "sufentanil consumption", "code": "opioid", "days": [ 0, 1 ], "primary": false }, { "measure": "effective PCIA presses", "code": "other", "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": "Esketamine given to awake women under CSEA after delivery and continued in a 24 h PCIA pump, so 'some'. Planned n recalculated mid-trial from 1248 to 336. Excluded prenatal EPDS >= 10." }, { "id": "T121", "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 after cord clamping; PCIA with esketamine 1.25 mg/kg + sufentanil 100 ug", "start": "after_delivery", "end": "after_emergence" }, { "name": "Control group", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "cesarean", "procedure": "cesarean section in women with prenatal depressive symptoms", "depression_selection": "selected", "selection_criterion": "EPDS >= 10 before cesarean", "age_group": null, "depression_measures": [ { "measure": "EPDS (PPD = EPDS >= 10)", "code": "EPDS", "days": [ 42 ], "primary": true } ], "pain_measures": [ { "measure": "postoperative pain (unspecified)", "code": "other", "days": [], "primary": false }, { "measure": "opioid consumption", "code": "opioid", "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": "multi", "note": "Abstract only. Esketamine continued in a postoperative PCIA pump, so 'some' whatever the anesthesia (not stated). 174 enrolled, no planned size given. Adverse events named only generically. Blinding from 'double-blind'." }, { "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, "dose_note": "infusion from immediately after induction until abdomen closure, no bolus; morphine PCA only", "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": "elective gynecologic malignancy laparotomy (midline incision)", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "PHQ-9 (depressive symptoms = PHQ-9 >= 10)", "code": "PHQ9", "days": [ 7 ], "primary": false } ], "pain_measures": [ { "measure": "verbal NRS (rest/movement not stated) at 1, 2, 24, 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "subacute and chronic pain (NRS >= 4) at POD7 and 3 months", "code": "other", "days": [ 7, 90 ], "primary": false }, { "measure": "total morphine consumption within 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 started immediately after induction and ran until abdomen closure under GA, so 'none' with late_dosing true. TAP block given after intubation, before incision. Primary outcome QoR-40 at 48 h." }, { "id": "T123", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Esketamine supplement (sufentanil + esketamine PCIA)", "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 added to sufentanil 2 ug/kg in 100 mL", "start": "postoperative", "end": "after_emergence" }, { "name": "Sufentanil PCIA", "role": "control" } ], "anesthesia": "unclear", "conscious_dosing": "some", "late_dosing": null, "setting": "surgery", "procedure": "total hip or knee arthroplasty in elderly patients", "depression_selection": "unselected", "selection_criterion": "", "age_group": "older", "depression_measures": [ { "measure": "postoperative depression (scale not named)", "code": "OTHER", "days": [], "primary": false } ], "pain_measures": [ { "measure": "number of PCIA attempts", "code": "other", "days": [], "primary": false }, { "measure": "rescue analgesics within 48 h", "code": "other", "days": [ 0, 1, 2 ], "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": "Abstract only. Esketamine only in the postoperative PCIA pump, so 'some'. Depression named as a secondary outcome without a scale or time. 'Elderly' age cut-off not given. Delirium and other adverse events recorded. 120 randomized, no planned size given." }, { "id": "T124", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "name": "Group T (Esketamine group)", "role": "ketamine", "drug": "esketamine", "route": "epidural", "bolus_mg_per_kg": 0.2, "infusion_mg_per_kg_h": null, "infusion_hours": null, "pump": false, "dose_note": "0.2 mg/kg in 5 mL given slowly via the epidural catheter before skin closure; PCIA tramadol only", "start": "end_of_surgery", "end": "end_of_surgery" }, { "name": "Group C (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": "EPDS (PPD = EPDS >= 13)", "code": "EPDS", "days": [ 7, 42 ], "primary": false } ], "pain_measures": [ { "measure": "NRS at rest at 2, 6, 12, 24, 48 h", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "dynamic pain NRS at 24, 48 h", "code": "movement", "days": [ 1, 2 ], "primary": false }, { "measure": "uterine contraction pain NRS at 24, 48 h", "code": "other", "days": [ 1, 2 ], "primary": false }, { "measure": "cumulative PCIA bolus requests", "code": "other", "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 before skin closure in awake women under CSEA, so 'some'. Blinding lists clinicians, follow-up researchers and analysts but not the parturients. Excluded obvious preoperative depression." }, { "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, "dose_note": "slow bolus over about 30 s immediately after delivery and cord clamping; PCA sufentanil + butorphanol only", "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 combined spinal-epidural anesthesia", "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 at 2, 6, 24, 48 h", "code": "rest", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "movement-evoked VAS at 2, 6, 24, 48 h", "code": "movement", "days": [ 0, 1, 2 ], "primary": true }, { "measure": "effective PCA presses at 6, 12, 24, 48 h", "code": "other", "days": [ 0, 1, 2 ], "primary": false }, { "measure": "rescue analgesia rate within 24 h", "code": "other", "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": "IV bolus after cord clamping in awake women under CSEA, so 'some'. Registration stated as retrospective. TAP block after skin closure." }, { "id": "T126", "eligible": true, "exclusion_reason": null, "timing_comparison": false, "arms": [ { "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, "dose_note": "0.25 mg/kg mixed with 0.375% ropivacaine, 20 mL, single T5 erector spinae plane block after induction and positioning", "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, "dose_note": "0.5 mg/kg mixed with 0.375% ropivacaine, 20 mL, single T5 erector spinae plane block after induction and positioning", "start": "after_induction", "end": "before_end_of_surgery" }, { "name": "Group R (ropivacaine)", "role": "control" } ], "anesthesia": "general_and_regional", "conscious_dosing": "none", "late_dosing": false, "setting": "surgery", "procedure": "elective thoracoscopic surgery", "depression_selection": "unselected", "selection_criterion": "", "age_group": "adult", "depression_measures": [ { "measure": "HADS depression subscale", "code": "HADS_D", "days": [], "primary": false } ], "pain_measures": [ { "measure": "duration of ESP block analgesia (time to PCIA use)", "code": "other", "days": [ 0, 1 ], "primary": true }, { "measure": "VAS at rest", "code": "rest", "days": [], "primary": false }, { "measure": "VAS while coughing", "code": "movement", "days": [], "primary": false }, { "measure": "postoperative rescue analgesia", "code": "other", "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 perineurally in the ESP block, which the text places after GA induction, double-lumen intubation and lateral positioning, before the operation: 'none', late false (single injection before surgery; slow absorption from the block not considered). Control gets the same ropivacaine block. HADS and VAS timepoints not stated." } ]