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Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

• \-

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University School of Medicin
RECRUITING
Hangzhou
Contact Information
Primary
min Yan, doctor
zryanmin@zju.edu.cn
+86 13757118632
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2027-07-15
Participants
Target number of participants: 1000
Treatments
Cohort 1: Remimazolam group (RM)
Elderly patients who receive remimazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist).
Cohort 2: Midazolam group (MZ)
Elderly patients who receive midazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist).
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, Zhejiang University, School of Medicine

This content was sourced from clinicaltrials.gov

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