Impact of Intraoperative Midazolam on Delirium Outcome of Elderly Patients (I-IMODE): a Multicentre Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: f
View:
• 65 ≤ Age ≤ 85 years old;
• Elective surgery under general anesthesia, with an estimated surgery time of ≥ 2 hours;
• Non cardiac surgery, non neurosurgical surgery;
• ASA grades I-III;
• Agree to participate and sign the informed consent form;
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 612
Treatments
Placebo_comparator: Saline group
The control group patients were given 2 mL physiological saline during anesthesia induction.
Experimental: Midazolam group
The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction
Related Therapeutic Areas
Sponsors
Collaborators: Changhai hospital of Navy Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliate Hospital of Guangxi Medical College, China-Japan Union Hospital, Jilin University, The Second Norman Bethune Hospital of Jilin University
Leads: Chinese PLA General Hospital