Jiaxing University Affiliated Hospital
Jiaxing, Zhejiang, 314000, China
NCT Number: NCT07725185
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Jiaxing, Zhejiang, 314000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: postoperative day 1
postoperative day 1 hs-cTnT level
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.
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.
Time frame: immediate postoperative
immediate postoperative hs-cTnT
Time frame: within 30 days postoperatively
incidence of myocardial injury after noncardiac surgery (MINS) within 30 days postoperatively
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.
Time frame: intraoperative
incidence of intraoperative hypotension (defined as MAP <65 mmHg for at least 1 minute or requiring vasopressor support)
Affiliated Hospital of Jiaxing University
Other
Effects of Remimazolam and Propofol on Postoperative Myocardial Injury in Elderly Patients Undergoing General Anesthesia
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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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