Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-… (NCT07746505) | Clinical Trial Compass
RecruitingNot Applicable
Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery
China1,000 participantsStarted 2026-06-15
Plain-language summary
This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.
Who can participate
Age range
65 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
. Age 65 years or older.
. Scheduled for elective non-cardiac surgery under general anesthesia.
. American Society of Anesthesiologists physical status I to IV.
. Planned airway management with tracheal intubation or a laryngeal mask airway.
. Written informed consent provided by the participant or the participant's legally authorized representative.
Exclusion criteria
. Long-term preoperative benzodiazepine use.
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.
1This trial is comparing remimazolam and midazolam specifically to see which one causes less dangerous drops in blood pressure during surgery — given my age and health history, does my doctor think I'm at particular risk for that kind of blood pressure drop, and would that make one drug safer for me than the other?
2Since this trial is listed as Phase NA, what does that mean for what's already known about the safety and effectiveness of remimazolam compared to midazolam in elderly patients like me — is there enough existing evidence that my doctor feels comfortable discussing the potential risks?
3The trial is measuring blood pressure drops during surgery using something called a Time-Weighted Average — can my doctor explain in plain terms why low blood pressure during an operation is a serious concern for older patients, and how significant that risk is for someone in my specific situation?
4Would taking part in this trial change any other parts of how my surgery or anesthesia is managed, or would everything else about my care stay the same as it would be outside the trial?
5Before considering this trial, should I ask about whether the standard anesthesia approach my surgical team already uses might be just as good at preventing blood pressure drops, so I can compare that option against what's being studied here?
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.
What they're measuring
1
Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline)
Timeframe: From anesthetic induction through the end of surgery (intraoperative period)
Trial details
NCT IDNCT07746505
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine