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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Cohort 1: Remimazolam group (RM)
Group B: Cohort 2: Midazolam group (MZ)

Trial outcomes

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).

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

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 from discontinuation of anesthetics to removal of the endotracheal tube.

Time frame
During anesthesia emergence
3

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

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.

Time frame
24 hours after surgery
4

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

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).

Time frame
Day of surgery and postoperative day 2

Other outcomes

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