Effects of Remimazolam on Postoperative Myocardial Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, Propofol.
- Who it may be relevant to
- Registry conditions: Myocardial Injury. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Remimazolam and Propofol on Postoperative Myocardial Injury in Elderly Patients Undergoing General Anesthesia
Overview
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
- Drug Remimazolam
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 Propofol
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.
Primary outcome measures
- postoperative day 1 hs-cTnT [Time frame: postoperative day 1]
Secondary outcome measures (6)
- CO-AUC₀-₁₅ₘᵢₙ [Time frame: within the first 15 minutes after induction of anaesthesia]
- AUC for other cardiac function parameters [Time frame: within the first 15 minutes after induction of anaesthesia]
- immediate postoperative hs-cTnT [Time frame: immediate postoperative]
- incidence of MINS within 30 days postoperatively [Time frame: within 30 days postoperatively]
- Quality of Recovery Score [Time frame: 24 Hours Post-Operatively]
- incidence of intraoperative hypotension [Time frame: intraoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Jiaxing University Affiliated Hospital — Jiaxing
Identifiers
NCT: NCT07725185 · 2025-LP-369