Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery
NCT07746505
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
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. \- 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. \-
Conditions5
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NCT07746505