Myocardial InjuryNCT07725185
Effects of Remimazolam on Postoperative Myocardial Injury
A study testing Remimazolam and Propofol in people with Myocardial Injury, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Remimazolam and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Remimazolam and Propofol on Postoperative Myocardial Injury in Elderly Patients Undergoing General Anesthesia
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.
Read the 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.
- Conditions
- Myocardial Injury
- Being tested
- Remimazolam, Propofol
- Keywords
- Remimazolam, Propofol, Cardiac output, Perioperative myocardial injury, hs-cTnT, Elderly surgical patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | 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. Receives: Drug: Remimazolam |
| Propofol | Active comparator | 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative day 1 hs-cTnT
postoperative day 1 hs-cTnT level
Measured: postoperative day 1
Secondary outcomes (6)
CO-AUC₀-₁₅ₘᵢₙ
Area under the curve (AUC) of the change in cardiac output (CO) from baseline within the first 15 minutes after induction.
Measured: 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.
Measured: within the first 15 minutes after induction of anaesthesia
immediate postoperative hs-cTnT
immediate postoperative hs-cTnT
Measured: immediate postoperative
incidence of MINS within 30 days postoperatively
incidence of myocardial injury after noncardiac surgery (MINS) within 30 days postoperatively
Measured: 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.
Measured: 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)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725185
- Sponsor's protocol ID
- 2025-LP-369
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remimazolam and Propofol on Postoperative Myocardial Injury in Elderly Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT07725185
- Acronym / sponsor ID
- 2025-LP-369
- Conditions
- Myocardial Injury
- Keywords
- Remimazolam, Propofol, Cardiac output, Perioperative myocardial injury, hs-cTnT, Elderly surgical patients
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: RemimazolamInduction 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. |
| Propofol | Active comparator | Drug: PropofolInduction 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamInduction 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 |
| PropofolInduction 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 |
Primary outcome
postoperative day 1 hs-cTnT
Time frame: postoperative day 1
postoperative day 1 hs-cTnT level
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Propofol in people with Myocardial Injury, run by Affiliated Hospital of Jiaxing University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative day 1 hs-cTnT (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.