Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy

This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.

Inclusion Criteria: * Age ≥ 65 years. * Body mass index (BMI) between 18 and 28 kg/m². * ASA physical status I-III. * Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital. * Able and willing to sign informed consent. Exclusion Criteria: * Severe respiratory, cardiovascular, renal, or hepatic dysfunction. * Stroke within the past 6 months or other central nervous system diseases. * History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders. * History of alcohol abuse or psychoactive substance dependence. * Severe visual, hearing, or language impairment preventing communication. * Allergy or contraindication to propofol or benzodiazepines. * Preoperative cognitive impairment assessed by MMSE (≤24 for ≥middle-school education; ≤20 for primary school; ≤17 for no formal education). * Participation in another drug clinical trial within 1 month before surgery.