An interventional study of Remimazolam and Propofol in Myocardial Injury, sponsored by Affiliated Hospital of Jiaxing University. Enrolling by invitation at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Affiliated Hospital of Jiaxing University · Not applicable, Interventional, and Prevention
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.
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.
Affiliated Hospital of Jiaxing University is the lead sponsor of 17 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 remimazolam: 0.2-0.4 mg/kg; maintenance dose of remimazolam: 0.2-1 mg/kg/h. Maintain BIS values between 40 and 60.
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.
postoperative day 1 hs-cTnT
postoperative day 1 hs-cTnT level
Time frame: postoperative day 1
CO-AUC₀-₁₅ₘᵢₙ
Area under the curve (AUC) of the change in cardiac output (CO) from baseline within the first 15 minutes after induction.
Time frame: 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.
Time frame: within the first 15 minutes after induction of anaesthesia
immediate postoperative hs-cTnT
immediate postoperative hs-cTnT
Time frame: immediate postoperative
incidence of MINS within 30 days postoperatively
incidence of myocardial injury after noncardiac surgery (MINS) within 30 days postoperatively
Time frame: within 30 days postoperatively
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.
Time frame: 24 Hours Post-Operatively
incidence of intraoperative hypotension
incidence of intraoperative hypotension (defined as MAP \<65 mmHg for at least 1 minute or requiring vasopressor support)
Time frame: intraoperative
Plan to share: Yes
Supporting information: Study protocol
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Studies of the drug tested here: Remimazolam
Affiliated Hospital of Jiaxing University