This interventional trial (n=400) will examine the effect of intraoperative esketamine infusion on depressive symptoms in obese patients undergoing laparoscopic sleeve gastrectomy.
Led by The Second Hospital of Anhui Medical University, the trial aims to assess the efficacy and safety of esketamine as an analgesic intravenous anesthetic in obese patients. The bidirectional relationship between obesity and mood disorders suggests a potential link between the two, with bariatric surgery often leading to reductions in depressive symptoms. However, depressive symptoms may persist in some patients postoperatively. Therefore, the study will investigate whether esketamine infusion during surgery can mitigate postoperative depressive symptoms in obese patients.
Participants, aged 18 to 65 with a BMI of ≥40kg/m2 or BMI>35 kg/m2 with an existing comorbidity, will be randomised into two groups: a control group receiving standardised general anaesthesia with opioids and an intervention group receiving a standardised non-opioid anaesthesia regimen with esketamine.
Primary outcome measures include changes in depressive symptoms assessed by the Hamilton Depression Rating Scale before surgery and at the postoperative 3-month mark. Secondary outcome measures include postoperative anxiety, cognition, incidence of postoperative nausea and vomiting, postoperative pain, time to the first rescue analgesics, consumption of anaesthetics, length of surgery and anaesthesia, quality of recovery, adverse event rate, BMI, sleep quality, gastrointestinal function, and overall health and functional status, evaluated before surgery and at the postoperative 3-month mark.
The estimated start date for the study is January 1, 2024, with an estimated primary completion date of October 1, 2025, and an estimated study completion date of December 1, 2025.
Trial Details
Trial Number