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NCT Number: NCT07179913

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

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.

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Key information

Conditions

Depressed Bariatric Surgery Behavior Behavioral Symptoms Consciousness Disorders Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhiwen Li

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esketamine

Drug

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

Drug

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.

Primary outcomes

  1. Hamilton Depression Scale ≥7

    Time frame: Seven days after the operation

    The proportion of patients with depression (Hamilton Depression score ≥7)

Secondary outcomes

  1. the proportion of patients with depression

    Time frame: 30 days, 3 months, 6 month and 1 year after the operation

    The proportion of patients with depression

Other outcomes

  1. BMI in kg/m^2

    Time frame: 30 days, 3 months, 6 months and 1 year after operation

    BMI in kg/m^2

  2. the proportion of patients with anxeity

    Time frame: 30 days, 3 months, 6 months and 1 yea rafter operation

    the proportion of patients with anxeity

  3. living quality score

    Time frame: 30 days, 3 months, 6 months and 1 year after operation

    living quality score

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression:A Prospective Radomized Controlled Trial

Acronym: esketamine

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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