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

NCT ID: NCT07179913

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2026-09-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

dexmedetomidine

Group Type: PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type: 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.

esketamine

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

lizhiwen

study director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiwen Li, Doctor of Medicine

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Central Contacts

Dongdong Cao, Medicine doctoral student

Role: CONTACT

dalianyike@126.com

+8618243008603

Other Identifiers

25K322-001

Identifier Type: -

Identifier Source: org_study_id