Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery
Recruiting now
Conditions studied: General Anesthesia, Aged, Intraoperative Hypotension, Anxiety
In brief
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.
Key facts
- Study ID
- NCT07746505
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 1000
- Starts
- 2026-06-15
- Expected to finish
- 2027-07-15
- Last updated by the study team
- 2026-08-05
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Long-term preoperative benzodiazepine use.
- Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.
- History of drug abuse or alcoholism within the past 2 years.
- No preoperative cognitive assessment available.
- Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18.
- Refusal to provide informed consent.
Where it is running
- The Second Affiliated Hospital of Zhejiang University School of Medicin — Hangzhou, China (enrolling)
Full record on ClinicalTrials.gov
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