RecruitingPhase 4

Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery in Video-Assisted Thoracoscopic Surgery

China1,058 participantsStarted 2025-07-31

Plain-language summary

Myocardial injury after noncardiac surgery (MINS) refers to postoperative elevation of cardiac troponin (cTn) levels caused by underlying ischemic mechanisms (i.e., coronary artery supply-demand imbalance or atherosclerotic thrombosis) without obvious non-ischemic causes (such as pulmonary embolism), with at least one cTn concentration exceeding the 99th percentile of the test reference upper limit, regardless of whether clinical symptoms and ECG changes are present. MINS, including myocardial infarction and ischemic myocardial injury, typically occurs within 30 days after surgery, most commonly within the first 2 postoperative days. It is an independent risk factor for 30-day postoperative mortality and is also closely associated with increased risk of mortality and vascular complications within 2 years . MINS is a common cardiovascular complication after thoracic surgery. Therefore, reducing the incidence of MINS in non-cardiac thoracic surgery to improve patient outcomes is a critical issue in anesthetic management for thoracic surgery. Ciprofol is a Class 1 innovative drug independently developed in China with global intellectual property rights. Currently, Ciprofol has completed Phase III clinical trials in China and the United States; its approved indications in China include sedation or anesthesia for various diagnostic procedures, general anesthesia for surgical operations, and sedation during intensive care unit (ICU) stays. Completed drug clinical trials and published clinical trial data of Ciprofol indicate that it can better maintain circulatory stability and ideal anesthetic depth during anesthesia induction and maintenance, making it a promising intravenous general anesthetic alternative to propofol. Maintaining hemodynamic stability is an important measure to reduce cardiovascular complications during the perioperative period. Given the good circulatory stability and sedative efficacy of Ciprofol, this study aims to investigate the impact of Ciprofol on MINS in non-cardiac thoracic surgery.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Scheduled for elective video-assisted thoracoscopic (VATS)-assisted thoracic surgery (lobectomy, segmentectomy, wedge resection of two or more lung tissues, mediastinal tumor resection) under general anesthesia;
. Aged 45 to 80 years (inclusive) at the time of randomization;
. Expected postoperative hospital stay of ≥3 days;
. Signed a written informed consent to participate in the study.

Exclusion criteria

. Patients allergic to propofol, Ciprofol, or analogs of drug excipient components (soybeans, eggs, milk);
. Patients with unstable angina;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is looking at whether ciprofol, a sedation drug, can reduce the risk of myocardial injury after video-assisted thoracoscopic surgery — given that I'm having or considering this type of surgery, is protecting my heart during the procedure something I should be concerned about in my specific situation?
2Since this is a Phase 4 trial, ciprofol is already approved and in use — but does that mean we have good safety data on how it affects heart outcomes in people like me, or are there still unknowns this study is trying to answer?
3The trial is measuring how often myocardial injury occurs after non-cardiac surgery — how common is this complication in thoracoscopic procedures generally, and what would it mean for my recovery if it happened to me?
4Would taking part in this trial change anything about how my anesthesia or sedation is managed during my surgery, and are there any risks specific to being given ciprofol versus whatever would normally be used?
5Is there a standard anesthesia approach already being used for thoracoscopic surgery that has a well-established track record for heart safety, and would you recommend that over enrolling in this trial given my overall health profile?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the incidence of myocardial Injury after non-cardiac surgery

Timeframe: Within the first 30 days after surgery

Trial details

NCT IDNCT07028593

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Ailin Luo, MD&PhD

13507122565 alluo@tjh.tjmu.edu.cn

View on ClinicalTrials.gov More Myocardial Injury trials