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

This interventional trial (n=400) investigates the effect of esketamine infusion during laparoscopic sleeve gastrectomy on postoperative depressive symptoms among obese patients.

Conducted by The Second Hospital of Anhui Medical University, the study aims to explore whether esketamine, known for its rapid onset and elimination, can mitigate depressive symptoms in this patient population. Obesity and depression have a bidirectional relationship, and bariatric surgery, though effective for weight loss, may still leave some patients with sustained depressive symptoms postoperatively. The trial will compare a standard opioid anesthesia regimen with an experimental non-opioid anesthesia protocol involving esketamine.

Primary outcome measures include changes in depression severity assessed by the Hamilton Depression Rating Scale (HAMD) before surgery and at three months postoperatively.

Secondary outcome measures encompass various parameters such as postoperative anxiety, cognition, pain, and brain function, evaluated before surgery and at the postoperative three-month mark.

The study, initiated on January 1, 2024, is anticipated to conclude by December 1, 2025.

Trial Details

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.

NCT Number NCT06199011

Data attribution

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