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COMPLETED
NCT07351474
NA

Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrectomy: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

65 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2026-01-21

Completion Date

2026-08-05

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

Remimazolam

Remimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.

DRUG

Propofol

Propofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China