Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: General Anesthesia, Aged, Intraoperative Hypotension, Anxiety. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study
Overview
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.
Detailed description
This is a prospective, observational, cohort study. The exposure is the benzodiazepine sedative actually used at induction; patients are grouped as the remimazolam (RM) or midazolam (MZ) cohort based on the clinical record. Induction and maintenance are individualized by the attending anesthesiologist ; investigators only observe and collect data without altering routine care. All patients receive standard monitoring (ECG, SpO₂, non-invasive/invasive blood pressure, end-tidal CO₂, anesthetic depth). Collected data include demographics, medical history and risk factors, medication history, examination and laboratory results, and intraoperative variables (ASA class, surgery type and duration, hypotension, anesthetic and opioid doses, fluid balance, blood loss, transfusion).
Primary outcome measures
- 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) [Time frame: From anesthetic induction through the end of surgery (intraoperative period)]
Secondary outcome measures (7)
- Vasoactive drug requirement [Time frame: Induction period and entire perioperative period Cumulative dose and frequency of vasoactive agents]
- Time to Extubation [Time frame: During anesthesia emergence]
- Quality of Recovery at 24 Hours Postoperatively as Assessed by the Quality of Recovery-15 (QoR-15) Questionnaire [Time frame: 24 hours after surgery]
- Perioperative Anxiety Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [Time frame: 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) [Time frame: From the end of surgery until hospital discharge, an average of 7 days]
- Incidence of Anesthesia-Related Adverse Events (Composite) [Time frame: perioperative]
- Length of Stay in the Post-Anesthesia Care Unit (PACU) [Time frame: From PACU admission until PACU discharge readiness, assessed up to 24 hours after surgery]
Eligibility criteria
Inclusion criteria
- 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.
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Exclusion criteria
- 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.
7.Refusal to provide informed consent.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University School of Medicin — Hangzhou
Identifiers
NCT: NCT07746505 · 2026-0835