Effects of Remimazolam on Postoperative Myocardial Injury

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myocardial Injury
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jiaxing, Zhejiang, China, 314000
      • Jiaxing University Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam; 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.	Drug: Remimazolam; 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.
Active Comparator: Propofol; 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.	Drug: Propofol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative day 1 hs-cTnT	postoperative day 1 hs-cTnT level	postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery Score	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.	24 Hours Post-Operatively
CO-AUC₀-₁₅ₘᵢₙ	Area under the curve (AUC) of the change in cardiac output (CO) from baseline within the first 15 minutes after induction.	within the first 15 minutes after induction of anaesthesia
AUC for other cardiac function parameters	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.	within the first 15 minutes after induction of anaesthesia
immediate postoperative hs-cTnT	immediate postoperative hs-cTnT	immediate postoperative
incidence of MINS within 30 days postoperatively	incidence of myocardial injury after noncardiac surgery (MINS) within 30 days postoperatively	within 30 days postoperatively
incidence of intraoperative hypotension	incidence of intraoperative hypotension (defined as MAP <65 mmHg for at least 1 minute or requiring vasopressor support)	intraoperative

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac output; Propofol; Remimazolam; Perioperative myocardial injury; Elderly surgical patients; hs-cTnT
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; remimazolam
• Other Study ID Numbers: 2025-LP-369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No