RecruitingPhase 1NCT06963112

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


Sponsor

Chinese PLA General Hospital

Enrollment

612 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving midazolam (a mild sedative) during surgery helps prevent confusion and disorientation — called delirium — in older adults after an operation. **You may be eligible if...** - You are between 65 and 85 years old - You are scheduled for elective (non-emergency) surgery under general anesthesia lasting at least 2 hours - Your surgery is not on the heart or brain - You are in generally good health or have only mild-to-moderate health conditions (ASA grades I–III) - You are willing to sign a consent form **You may NOT be eligible if...** - You have a history of depression, schizophrenia, or other mental health conditions - You have a history of moderate stroke or significant neurological disorders - You regularly take benzodiazepine medications (such as Valium or Xanax) - Your BMI falls outside the range of 18.5–30 kg/m² Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMidazolam

The intervention group patients were given 2mg midazolam injection (Jiangsu Enhua Pharmaceutical Co., Ltd.) during anesthesia induction

DRUGSaline

The control group patients were given 2 mL physiological saline.


Locations(1)

Chinese PLA General Hospital

Beijing, China

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NCT06963112


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