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

Phase 4Active Not RecruitingNCT07179913

The First Hospital of Jilin University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Depressed Bariatric Surgery

Interventions

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.

DexmedetomidineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hamilton Depression Scale ≥7

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

Time frame: Seven days after the operation

Secondary Outcomes

the proportion of patients with depression

The proportion of patients with depression

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