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NCT Number: NCT07746505

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

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.

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Key information

Conditions

General Anesthesia Aged Anxiety Anxiety Disorders Intraoperative Hypotension Mental Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicin

Hangzhou, China

Location status: Recruiting

Location contact

min Yan, doctor

CONTACT

[email protected]

+86 13757118632

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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)

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

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

Secondary outcomes

  1. Vasoactive drug requirement

    Time frame: Induction period and entire perioperative period Cumulative dose and frequency of vasoactive agents

  2. Time to Extubation

    Time frame: During anesthesia emergence

    Time from discontinuation of anesthetics to removal of the endotracheal tube.

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

    Time frame: 24 hours after surgery

    Quality of postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a 15-item patient-reported instrument covering physical comfort, physical independence, emotional state, psychological support, and pain. Each item is scored on an 11-point scale from 0 to 10. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.

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

    Time frame: Day of surgery and postoperative day 2

    Perioperative anxiety was assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The HADS-A consists of 7 items, each rated from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate greater anxiety (a worse outcome).

  5. 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

    postoperative delirium, acute kidney injury, stroke, acute myocardial infarction, or pulmonary infection. Postoperative delirium will be assessed using the Confusion Assessment Method or clinical documentation. Acute kidney injury will be defined according to Kidney Disease: Improving Global Outcomes criteria. Stroke and acute myocardial infarction will be diagnosed based on clinical, laboratory, electrocardiographic, imaging, and medical record evidence. Pulmonary infection will be diagnosed based on clinical symptoms, radiographic findings, laboratory results, and the need for antimicrobial treatment. In-hospital all-cause mortality will also be recorded.

  6. Incidence of Anesthesia-Related Adverse Events (Composite)

    Time frame: perioperative

    The number/proportion of participants experiencing one or more anesthesia-related adverse events during the perioperative period was recorded. Anesthesia-related adverse events included intraoperative awareness and postoperative nausea and vomiting (PONV).

  7. 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

    Length of stay in the post-anesthesia care unit (PACU), defined as the time from PACU admission until the patient meets PACU discharge readiness criteria, measured in minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

min Yan, doctor

CONTACT

[email protected]

+86 13757118632

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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