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Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery

RECRUITINGSponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine
Actively Recruiting
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Started2026-06-15
Est. completion2027-06-16
Eligibility
Age65 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 65 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Age 65 years or older.
2. Scheduled for elective non-cardiac surgery under general anesthesia.
3. American Society of Anesthesiologists physical status I to IV.
4. Planned airway management with tracheal intubation or a laryngeal mask airway.
5. Written informed consent provided by the participant or the participant's legally authorized representative.

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Exclusion Criteria:

1. Long-term preoperative benzodiazepine use.
2. Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.
3. History of drug abuse or alcoholism within the past 2 years.
4. No preoperative cognitive assessment available.
5. Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18.

7.Refusal to provide informed consent.

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Conditions5

AgedAnxietyGeneral AnesthesiaHeart DiseaseIntraoperative Hypotension

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