Effects of Remimazolam on Postoperative Myocardial Injury

NCT07725185 | Enrolling By Invitation DMC

• 1 other identifier: 2025-LP-369
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Injury

Keywords

Remimazolam; Propofol; Cardiac output; Perioperative myocardial injury; hs-cTnT; Elderly surgical patients

Outcome Measures

Primary Outcomes (1)

• postoperative day 1 hs-cTnT

  postoperative day 1 hs-cTnT level

  postoperative day 1

Secondary Outcomes (6)

• CO-AUC₀-₁₅ₘᵢₙ

  within the first 15 minutes after induction of anaesthesia

• AUC for other cardiac function parameters

  within the first 15 minutes after induction of anaesthesia

• immediate postoperative hs-cTnT

  immediate postoperative

• incidence of MINS within 30 days postoperatively

  within 30 days postoperatively

• Quality of Recovery Score

  24 Hours Post-Operatively

Study Arms (2)

Remimazolam

EXPERIMENTAL

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

Propofol

ACTIVE COMPARATOR

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

Interventions

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.

Remimazolam

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.

Propofol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, 314000, China

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)