Midazolam at anesthesia induction to lower postoperative delirium in older adults

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

This trial tests whether a small (2 mg) dose of midazolam given when anesthesia starts can lower postoperative delirium and anxiety in people aged 65–85 having elective non-cardiac surgery lasting two hours or more.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 612 (estimated)
• Ages: 65 Years to 85 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06963112 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase 1 trial randomizes elderly patients undergoing elective non-cardiac surgery to receive either 2 mg intravenous midazolam at anesthesia induction or an equal volume of saline. Participants are aged 65–85 years, ASA I–III, with expected surgery duration ≥2 hours, and patients with preexisting cognitive impairment, long-term benzodiazepine use, major neurological or psychiatric disorders, or contraindications to midazolam are excluded. Postoperative delirium and anxiety are assessed daily for 1–7 days after surgery, and cognitive function is reassessed at one month. The primary comparison is the incidence of delirium within the first postoperative week between the midazolam and placebo groups to inform clinical use in elderly surgical patients.

Who should consider this trial

Good fit: Ideal candidates are patients 65–85 years old undergoing elective non-cardiac surgery under general anesthesia expected to last ≥2 hours, with ASA I–III status, normal baseline cognition, not on long-term benzodiazepines, and without contraindications to midazolam.

Not a fit: Patients with existing cognitive impairment, significant neurological or psychiatric disorders, long-term benzodiazepine use, severe liver or respiratory dysfunction, sleep apnea, or other contraindications to midazolam are unlikely to be eligible and may not benefit.

Why it matters

Potential benefit: If successful, this could reduce the frequency of postoperative delirium and anxiety and improve early recovery in older surgical patients.

How similar studies have performed: Prior research on perioperative benzodiazepines and postoperative delirium has produced mixed results and sometimes linked benzodiazepines to increased delirium risk, so randomized evidence for low-dose induction midazolam in this population is limited and relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 65 ≤ Age ≤ 85 years old;
2. Elective surgery under general anesthesia, with an estimated surgery time of ≥ 2 hours;
3. Non cardiac surgery, non neurosurgical surgery;
4. ASA grades I-III;
5. Agree to participate and sign the informed consent form;

Exclusion Criteria:

1. Preoperative history of comorbidities such as depression and schizophrenia;
2. History of neurological disorders, moderate stroke;
3. Long term use of benzodiazepines before surgery;
4. 18.5≤BMI≤30 kg/m2
5. There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold;
6. There are communication barriers, such as severe dementia, language barriers, and severe hearing or visual impairments;
7. 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);
8. Preoperative severe liver and kidney dysfunction;
9. Patients expected to enter the ICU after surgery;

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (Recruiting)

Conditions Delirium; Anxiety; midazolam; delirium; anxiety