Myocardial Injury
Conditions
Keywords
Remimazolam, Propofol, Cardiac output, Perioperative myocardial injury, hs-cTnT, Elderly surgical patients
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.
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.
Interventions
DRUGRemimazolam
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.
DRUGPropofol
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.
Sponsors
Affiliated Hospital of Jiaxing University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative day 1 hs-cTnT | postoperative day 1 | postoperative day 1 hs-cTnT level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immediate postoperative hs-cTnT | immediate postoperative | immediate postoperative hs-cTnT |
| incidence of MINS within 30 days postoperatively | within 30 days postoperatively | incidence of myocardial injury after noncardiac surgery (MINS) within 30 days postoperatively |
| AUC for other cardiac function parameters | 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. |
| incidence of intraoperative hypotension | intraoperative | incidence of intraoperative hypotension (defined as MAP \<65 mmHg for at least 1 minute or requiring vasopressor support) |
| CO-AUC₀-₁₅ₘᵢₙ | 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. |
| Quality of Recovery Score | 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. |
Countries
China
Outcome results
None listed