Status:
RECRUITING
Intraoperative Midazolam on Delirium Outcome of Elderly Patients
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
Changhai hospital of Navy Medical University
China-Japan Union Hospital, Jilin University
Conditions:
Delirium
Anxiety
Eligibility:
All Genders
65-85 years
Phase:
PHASE1
Brief 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 postop...
Detailed Description
This study is a multicenter, randomized, double-blind, placebo-controlled trial. A total elderly patients who underwent elective non cardiac surgery were included in the plan and randomly divided into...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- Preoperative history of comorbidities such as depression and schizophrenia;
- History of neurological disorders, moderate stroke;
- Long term use of benzodiazepines before surgery;
- 18.5≤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;
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT06963112
Start Date
April 1 2025
End Date
August 1 2026
Last Update
September 25 2025
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, China, 100853