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Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy

StatusCompleted
PhaseNot applicable
Started2026-01-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-19
notable
Completed without a posted recruiting period
Final enrollment: 147 participants (planned 170)
Primary completion confirmed: July 2026 (last estimated December 2026)
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.
Trial Details
NCT Number NCT07351474
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Gastric Cancer, Postoperative Delirium
Enrollment 147 participants
Start Date 2026-01-21
Primary Completion 2026-07-25 (estimated)
Study Completion 2026-08-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-18