Intraoperative Midazolam on Delirium Outcome of Elderly Patients (NCT06963112) | Clinical Trial Compass
CompletedPhase 1
Intraoperative Midazolam on Delirium Outcome of Elderly Patients
China612 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range
65 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. Preoperative history of comorbidities such as depression and schizophrenia;
. History of neurological disorders, moderate stroke;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Long term use of benzodiazepines before surgery;
. BMI≤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;