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Active, not recruiting Phase 4

The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression

NCT07179913 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-05-01
Last updated
2026-05-08

Condition(s) studied

DepressedBariatric Surgery

Investigational drug(s) / intervention(s)

Esketamine →Dexmedetomidine →

Esketamine: For the subjects in the experimental group, esketamine 50mg/2ml was diluted with normal saline up to 50ml (with a concentration of esketamine at 1mg/ml), anesthesia induction begins with intravenous infusion of esketamine 0.25mg/kg (0.375ml/kg•h drug preparation solution), with a pumping duration of 40 minutes.After the operation, esketamine 0.25mg/kg and sufentanil 1.5ug/kg were added to the postoperative analgesic pump dilute to 100ml with normal saline, with a background dose of 2ml/h and a single booster dose of 2ml.

Dexmedetomidine: For the control group subjects, dexmedetomidine at a dose of 0.2mg/2ml was diluted with normal saline up to 50ml(dexmedetomidine concentration of 4μg/ml), anesthesia induction begins with intravenous infusion of 0.5μg/kg (0.083ml/kg•h), with a pumping duration of 40 minutes. The postoperative analgesic pump was added after the operation dilute with normal saline at a dose of 0.5μg/kg of dexmedetomidine and 1.5 μg/kg of sufentanil 100ml, with a background dose of 2ml/h and a single booster dose of 2ml.

Study summary

The aim of this study is to observe the antidepressant effect of low-dose esketamine in obese patients with preoperative depression and seeking bariatric surgery. We speculate that intraoperative infusion and the addition of a small dose of esketamine to the postoperative analgesic pump can help reduce the proportion of patients with depression after surgery, and may further improve postoperative recovery, reduce the use of postoperative opioids, shorten postoperative hospital stay, and improve postoperative quality of life of patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years old and \<65 years old * Patients with a BMI greater than 35 kg/m\^2 * Hamilton Depression score ≥7 points * Planned to undergo elective laparoscopic sleeve gastrectomy Exclusion Criteria: * ASA ≥ grade IV * Those who have had or are currently suffering from mental disorders other than anxiety and depression, such as schizophrenia, bipolar disorder, organic mental disorders, etc. * Those who are unable to cooperate in completing the scale assessment * Have received ketamine/esketamine treatment, or are allergic to ketamine/esketamine * Clarify ischemic cardiomyopathy or severe liver and kidney dysfunction (Child pugh grade C, CKD stage G5) * People with opioid dependence and those who have been taking various types of painkillers for a long time (more than 3 months) * Participate in other research

Primary outcome measure(s)

  • Hamilton Depression Scale ≥7 — Seven days after the operation
    The proportion of patients with depression (Hamilton Depression score ≥7)

Trial sites (1)

FacilityCityRegionStatus
Zhiwen Li Changchun Jilin
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07179913 on ClinicalTrials.gov ↗ ← All trials in China