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

NCT07179913 | Not Yet Recruiting Phase 4

• 1 other identifier: 25K322-001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depressed; Bariatric Surgery

Keywords

esketamine; bariatric surgery; depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale ≥7

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

  Seven days after the operation

Secondary Outcomes (1)

• the proportion of patients with depression

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

Other Outcomes (3)

• BMI in kg/m^2

  30 days, 3 months, 6 months and 1 year after operation

• the proportion of patients with anxeity

  30 days, 3 months, 6 months and 1 yea rafter operation

• living quality score

  30 days, 3 months, 6 months and 1 year after operation

Study Arms (2)

dexmedetomidine

PLACEBO COMPARATOR

Drug: Dexmedetomidine

esketamine

EXPERIMENTAL

Drug: Esketamine

Interventions

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.

esketamine

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.

dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Consciousness Disorders; Depression

Interventions

Esketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhiwen Li, Doctor of Medicine

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Dongdong Cao, Medicine doctoral student

CONTACT

+8618243008603; dalianyike@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study director

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 18, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share