Actively Recruiting
Intraoperative Midazolam on Delirium Outcome of Elderly Patients
Led by Chinese PLA General Hospital · Updated on 2025-09-25
612
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
C
Changhai hospital of Navy Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intraoperative Midazolam on Delirium Outcome of Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 65 and 85 years old
- Scheduled for elective surgery under general anesthesia with estimated surgery time of 2 hours or more
- Undergoing non-cardiac, non-neurosurgical surgery
- American Society of Anesthesiologists (ASA) grades I to III
- Agree to participate and sign the informed consent form
You will not qualify if you...
- History of depression, schizophrenia, or other preoperative comorbidities
- History of neurological disorders or moderate stroke
- Long-term use of benzodiazepines before surgery
- Body mass index between 18.5 and 30 kg/m2
- Cognitive impairment based on Mini Mental State Examination (MMSE) below standard threshold
- Severe communication barriers such as dementia, language, hearing, or visual impairments
- Contraindications for midazolam use, including severe respiratory dysfunction, severe liver or kidney damage, sleep apnea syndrome, or allergy to benzodiazepines
- Severe liver and kidney dysfunction before surgery
- Expected to require intensive care unit (ICU) admission after surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China, 100853
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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