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Low-dose Esketamine on Postoperative Depression in Bariatric Surgery Patients
NCT07179913Phase 4
Key facts
- Status
- Active, not recruiting
- Start
- May 2026
- Primary completion
- Nov 2026
- Countries
- 1
- Sponsor
- The First Hospital of Jilin University
- Modality
- Small Molecules
- Drugs
- esketamine
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 4, randomised trial of esketamine in major depressive disorder (MDD) (2 arms), sponsored by The First Hospital of Jilin University. Primary endpoint: Hamilton Depression Scale >= 7 at 7 days. Started May 2026; status: active, not recruiting.
02
Design
2 arms- Study design
- Randomized
esketamine
Intravenous infusion of esketamine 0.25mg/kg during anesthesia induction, followed by esketamine 0.25mg/kg and sufentanil 1.5ug/kg in postoperative analgesic pump.
dexmedetomidine
Intravenous infusion of dexmedetomidine 0.5μg/kg during anesthesia induction, followed by dexmedetomidine 0.5μg/kg and sufentanil 1.5μg/kg in postoperative analgesic pump.
03
Who it enrols
Adults under 65 with BMI > 35 kg/m^2, preoperative depression (Hamilton score >= 7), planned for elective laparoscopic sleeve gastrectomy. Excludes severe ASA grade, other mental disorders, prior ketamine/esketamine use, severe liver/kidney dysfunction, and opioid dependence.
04
Endpoints
Primary
Hamilton Depression Scale >= 7
Secondary
Proportion of patients with depression
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