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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
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.
Jiaxing University Affiliated Hospital
Jiaxing, Zhejiang, China
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
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