RecruitingPhase 4NCT07028593

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

Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery (CP-MINS) in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Randomized, Double-Blind, Propofol-Controlled, Multicenter Trial


Sponsor

Tongji Hospital

Enrollment

1,058 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of sedation medications (ciprofol versus propofol) used during lung surgery to see which one causes less heart muscle stress. **You may be eligible if:** - You are between 45 and 80 years old - You are scheduled for an elective lung surgery (such as lobe removal or wedge resection) using a minimally invasive (keyhole) approach under general anesthesia - You are expected to stay in the hospital for at least 3 days after surgery **You may NOT be eligible if:** - You are allergic to propofol, ciprofol, soy, eggs, or milk - You have unstable chest pain (angina), heart failure, or unstable heart condition - You have severe lung disease - You have poor kidney function - You are pregnant or breastfeeding - You have had a recent heart attack or stroke (within 3 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropofol

Using as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in propofol group.

DRUGciprofol

Using as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in ciprofol group.


Locations(1)

Tongji hospital

Wuhan, China

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NCT07028593


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