Clinical TrialDepressive DisordersEsketaminePlaceboUnknown status

Effect of Esketamine on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (EDSOP)

This interventional trial (n=400) investigates the effect of esketamine infusion during laparoscopic sleeve gastrectomy on postoperative depressive symptoms among obese patients.

Target Enrollment
400 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group trial comparing a standardized non-opioid anaesthesia strategy using intraoperative esketamine infusion versus standard opioid-based general anaesthesia in obese patients undergoing laparoscopic sleeve gastrectomy.

Primary objective is to evaluate postoperative depressive symptoms (HAMD) after esketamine-based anaesthesia; secondary outcomes include perioperative analgesia, opioid-related complications, and safety/tolerability.

Intervention arm receives loading esketamine 0.25 mg/kg with continuous intraoperative infusion (~0.25 mg/kg/h) plus dexmedetomidine; control arm receives induction sufentanil and remifentanil infusion with standard maintenance agents.

Study Arms & Interventions

Esketamine anaesthesia

experimental

Standardised non-opioid anaesthesia with intraoperative esketamine infusion and dexmedetomidine.

Interventions

  • Esketamine0.25 mg/kg
    via IV• intraoperative infusion

    Loading 0.25 mg/kg with continuous infusion ~0.25 mg/kg/h; coadministered dexmedetomidine 0.5 μg/kg; propofol and rocuronium for induction/airway management.

Opioid anaesthesia

active comparator

Standard opioid-based general anaesthesia including remifentanil and sufentanil.

Interventions

  • Placebo
    via IV• intraoperative infusion

    Induction sufentanil 0.5 μg/kg; remifentanil infusion 5–15 μg/kg/h; maintenance with propofol, sevoflurane and dexmedetomidine as per protocol.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • BMI≥40 kg/m2 or BMI>35 kg/m2 with an existing comorbidity
  • scheduled for selective LSG
  • American Society of Anesthesiologists physical status I-III
  • HAMD>7
  • with informed consent

Exclusion Criteria

  • Exclusion Criteria:
  • Patients diagnosed with significant comorbidities, such as cardiopathy, chronic respiratory conditions, abnormal hepatic and/or renal function, coagulation dysfunction, major psychiatric or neurological disorders
  • Patients allergy to esketamine or other drugs used in the study
  • Patients are scheduled for/plan to have an additional surgery during the 3-month follow-up period
  • Patients suffer from acute or chronic pain with analgesics, or take anticathartic, glucocorticoid medications
  • Patients involved in another research study
  • Patients will likely have problems, in the judgement of the investigator, with maintaining follow-up
  • Any other reasons the investigator feels is relevant for excluding the patient
  • lack of patient consent

Study Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment400 participants
  • Timeline
    Start: 2024-01-01
    End: 2025-12-01
  • Compounds
    EsketaminePlacebo
  • Topic
    Depressive Disorders

Locations

China

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