NCT06963112

Intraoperative Midazolam on Delirium Outcome of Elderly Patients

Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 612 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study was a multicenter, randomized, double-blind, placebo-controlled trial to treat elderly surgical patients with low-dose midazolam or placebo for anesthesia induction. The incidence of postoperative 7-day delirium was assessed and compared between two groups, to provide valuable reference for clinical practitioners in the use of midazolam in elderly surgical patients.

Detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled trial. A total elderly patients who underwent elective non cardiac surgery were included in the plan and randomly divided into an intervention group and a control group. The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction; The control group patients were given equal volume physiological saline. Follow up assessment of postoperative delirium and anxiety will be conducted 1-7 days after surgery, and cognitive function follow-up will be conducted 1 month after surgery.

Conditions

• Delirium
• Anxiety

Interventions

Type	Name	Description
DRUG	Midazolam	The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction
DRUG	Saline	The control group patients were given 2 mL physiological saline.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-05-08
• Last updated: 2025-09-25

Locations

1 site across 1 country: China