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NOT YET RECRUITING
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, randomized controlled clinical trial aims to evaluate whether remimazolam can reduce the incidence of postoperative delirium (POD) in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer. A total of 170 patients aged 65 years or older will be enrolled and randomized in a 1:1 ratio to receive either remimazolam or a propofol-midazolam regimen for anesthesia induction and maintenance. Standard perioperative monitoring, BIS-guided anesthesia depth control, and postoperative pain management will be applied in both groups. The primary outcome is the incidence of postoperative delirium within 5 days after surgery, assessed twice daily using the 3D-CAM. Secondary outcomes include emergence agitation, extubation time, postoperative pain scores, cognitive function at discharge, intraoperative hemodynamic stability, unplanned ICU admission, postoperative complications, and length of ICU stay. This study aims to determine whether remimazolam provides a safer and more effective anesthetic option for improving postoperative neurological outcomes and recovery in elderly patients undergoing laparoscopic radical gastrectomy.

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

170

Start Date

2026-01-01

Completion Date

2026-12-31

Last Updated

2026-01-20

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