drugset / Trial / NCT07351474

Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy

NCT07351474 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

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.

Timeline

Start
2026-01-21
Primary completion
2026-07-25
Completion
2026-08-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule — —
Subject Remimazolam Small molecule — —

Indications