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Effect of Esketamine on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

NCT06199011 · EDSOP · The Second Hospital of Anhui Medical University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
400
Target enrolment
—
Study sites

What it is testing

Summary

Esketamine, as a powerful analgesic intravenous anesthetic, has a rapid onset and elimination effect, does not inhibit spontaneous respiration, and can slightly stimulate the circulatory system. It has been confirmed that esketamine can effectively combat opioid related complications, especially life-threatening respiratory suppression. Thus becoming a new powerful perioperative analgesic drug. At the same time, esketamine has been licensed for the treatment of "resistant depression" and emergency treatment for patients in crisis states of depression. But the evidence for its safety and effectiveness is insufficient. We have designed a randomized controlled clinical trial to investigate the effect of an established general anesthesia strategy without opioids by using esketamine on postoperative depressive in obese patients undergoing laparoscopic sleeve gastrectomy.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Hamilton depression Rating Scale

    Measured over Before surgery and at the postoperative 3 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * BMI≥40kg/m2 or BMI\>35 kg/m2 with an existing comorbidity * scheduled for selective LSG * American Society of Anesthesiologists physical status I-III * HAMD\>7 * with informed consent Exclusion Criteria: * Patients diagnosed with significant comorbidities, such as cardiopathy, chronic respiratory conditions, abnormal hepatic and/or renal function, coagulation dysfunction, major psychiatric or neurological disorders * Patients allergy to esketamine or other drugs used in the study * Patients are scheduled for/plan to have an additional surgery during the 3-month follow-up period * Patients suffer from acute or chronic pain with analgesics, or take anticathartic, glucocorticoid medications * Patients involved in another research study * Patients will likely have problems, in the judgement of the investigator, with maintaining follow-up * Any other reasons the investigator feels is relevant for excluding the patient * lack of patient consent

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06199011 on ClinicalTrials.gov →

Last updated in the registry 2024-01-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance