Effect of Esketamine on Postoperative Depression, Gut Microbiota, Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
This prospective, randomized, double-blinded, parallel-group trial (n≈72) compares intraoperative esketamine 0.2 mg/kg versus saline adjunct to general anaesthesia to assess postoperative depression, gut microbiota, and bispectral index in female breast cancer patients.
Details
Prospective, randomized (1:1), parallel-group, quadruple‑masked clinical trial evaluating esketamine 0.2 mg/kg versus saline as an adjunct to general anaesthesia in female patients undergoing elective breast cancer surgery to assess postoperative depressive symptoms, gut microbiota changes, and bispectral index measures.
Primary outcomes include postoperative depression scores; secondary assessments include gut microbiota composition and intraoperative bispectral index data. Participants must be pre‑menopausal adults with MADRS ≥22 and ASA I–II.