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

Anxiety Delirium

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

Inclusion Criteria5

≤ 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;

Exclusion Criteria9

Preoperative history of comorbidities such as depression and schizophrenia;
History of neurological disorders, moderate stroke;
Long term use of benzodiazepines before surgery;
≤BMI≤30 kg/m2
There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold;
There are communication barriers, such as severe dementia, language barriers, and severe hearing or visual impairments;
There are any contraindications for the use of midazolam (contraindications for patients with severe respiratory dysfunction, patients with severe liver and kidney damage, patients with sleep apnea syndrome, and patients known to be allergic to benzodiazepines);
Preoperative severe liver and kidney dysfunction;
Patients expected to enter the ICU after surgery;