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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07179913
Acronym
esketamine
Enrollment
40
Registered
2025-09-18
Start date
2026-05-01
Completion date
2026-11-20
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Depressed

Keywords

esketamine, bariatric surgery, depression

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.

Interventions

DRUGEsketamine

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.

DRUGDexmedetomidine

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.

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Depression Scale ≥7Seven days after the operationThe proportion of patients with depression (Hamilton Depression score ≥7)

Secondary

MeasureTime frameDescription
the proportion of patients with depression30 days, 3 months, 6 month and 1 year after the operationThe proportion of patients with depression

Countries

China

Contacts

STUDY_DIRECTORZhiwen Li, Doctor of Medicine

The First Hospital of Jilin University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026