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

NCT07746505 | Recruiting

• 1 other identifier: 2026-0835
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia; Anxiety; Aged; Intraoperative Hypotension

Keywords

Remimazolam; Midazolam; Elderly; Non-cardiac surgery; Anesthesia induction; Hemodynamic stability; Quality of recovery

Outcome Measures

Primary Outcomes (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)

  Intraoperative hypotension burden was quantified from mean arterial pressure (MAP) recordings obtained from anesthetic induction through the end of surgery (induction and maintenance periods).

  From anesthetic induction through the end of surgery (intraoperative period)

Secondary Outcomes (7)

• Vasoactive drug requirement

  Induction period and entire perioperative period Cumulative dose and frequency of vasoactive agents

• Time to Extubation

  During anesthesia emergence

• Quality of Recovery at 24 Hours Postoperatively as Assessed by the Quality of Recovery-15 (QoR-15) Questionnaire

  24 hours after surgery

• Perioperative Anxiety Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

  Day of surgery and postoperative day 2

• Composite of Major Organ Complications (Postoperative Delirium, Acute Kidney Injury, Stroke, Acute Myocardial Infarction, Pulmonary Infection, In-Hospital All-Cause Mortality, Postoperative Length of Stay, and Unplanned Reoperation)

  From the end of surgery until hospital discharge, an average of 7 days

Study Arms (2)

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).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients (≥65 years) scheduled for elective non-cardiac surgery under general anesthesia at a single tertiary center, who receive a benzodiazepine sedative (remimazolam or midazolam) for induction as part of routine clinical care.

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.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicin

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

min Yan, doctor

CONTACT

+86 13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: August 5, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 16, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-06

Locations

CN (1)