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Enrolling by Invitation

NCT Number: NCT07725185

Effects of Remimazolam on Postoperative Myocardial Injury

This study is designed as a prospective, double-blind, randomized controlled trial to investigate the effect of remimazolam on intraoperative cardiac output (CO) in elderly patients undergoing general anesthesia, and to evaluate its protective efficacy against elevated high-sensitivity cardiac troponin T (hs-cTnT) levels and perioperative myocardial injury.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, 314000, China

About this study

This study is designed as a prospective, double-blind, randomized controlled trial to compare the differential effects between remimazolam and propofol on intraoperative cardiac output (CO) in elderly patients undergoing general anesthesia. Postoperative serial measurements of high-sensitivity cardiac troponin T (hs-cTnT) will be performed, and all enrolled participants will be prospectively followed up for 30 days postoperatively to document the incidence of Myocardial Injury after Noncardiac Surgery (MINS). The core technical workflows of this trial are standardized titration of study drug dosage, continuous intraoperative hemodynamic monitoring of CO, and systematic, time-point-aligned collection of perioperative biomarkers including hs-cTnT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 65 years
  • Elderly hospitalized patients scheduled to undergo general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Surgery to be performed in the supine position
  • Ability to communicate with the investigator and to cooperate in completing the assessment scales
  • Expected duration of surgery ≥ 2 hours

Exclusion criteria

  • Congenital heart disease, severe cardiac conduction block, or implanted cardiac pacemaker;
  • History of cerebral infarction, cerebral hemorrhage, or stroke within the past 3 months;
  • Known allergy to remimazolam or propofol;
  • Severe mental illness, history of analgesic abuse, or addiction to psychotropic drugs;
  • Patient or family members refuse surgery or anesthesia, or are unable to complete the required questionnaires.

Treatment and study plan

Remimazolam

Drug

Induction dose of remimazolam: 0.2-0.4 mg/kg; maintenance dose of remimazolam: 0.2-1 mg/kg/h. Maintain BIS values between 40 and 60.

Propofol

Drug

Induction dose of propofol : 1.5 -2.5mg/kg; maintenance dose of propofol : 1.5-4.5mg/kg/h. Maintain BIS values between 40 and 60.

Primary outcomes

  1. postoperative day 1 hs-cTnT

    Time frame: postoperative day 1

    postoperative day 1 hs-cTnT level

Secondary outcomes

  1. CO-AUC₀-₁₅ₘᵢₙ

    Time frame: within the first 15 minutes after induction of anaesthesia

    Area under the curve (AUC) of the change in cardiac output (CO) from baseline within the first 15 minutes after induction.

  2. AUC for other cardiac function parameters

    Time frame: within the first 15 minutes after induction of anaesthesia

    Area-under-the-curve (AUC) values derived from the following haemodynamic parameters will also be evaluated: MAP, HR, CI, SV, SI, ICON, SVV, FTC, TFC, and STR.

  3. immediate postoperative hs-cTnT

    Time frame: immediate postoperative

    immediate postoperative hs-cTnT

  4. incidence of MINS within 30 days postoperatively

    Time frame: within 30 days postoperatively

    incidence of myocardial injury after noncardiac surgery (MINS) within 30 days postoperatively

  5. Quality of Recovery Score

    Time frame: 24 Hours Post-Operatively

    Quality of Recovery Score (QoR-15) at 24 Hours Post-Operatively;The score ranges from 0 to 150 points, with higher scores indicating better postoperative recovery quality.

  6. incidence of intraoperative hypotension

    Time frame: intraoperative

    incidence of intraoperative hypotension (defined as MAP <65 mmHg for at least 1 minute or requiring vasopressor support)

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiaxing University

Other

Registry information

Official study title

Effects of Remimazolam and Propofol on Postoperative Myocardial Injury in Elderly Patients Undergoing General Anesthesia

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 24, 2026
Registry last updated
Jul 24, 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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