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

Thoracoscopic Surgery Thoracic Diseases Myocardial Injury

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

Inclusion Criteria4

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 Criteria8

Patients allergic to propofol, Ciprofol, or analogs of drug excipient components (soybeans, eggs, milk);
Patients with unstable angina;
Patients with congestive heart failure or hemodynamic instability requiring vasopressor agents;
Patients with severe COPD (FEV1 \< 1 L);
Glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m²;
Patients with severe hepatic dysfunction (ALT or AST elevation exceeding 1.5 times the upper limit of normal);
Male or female patients planning to conceive within the next 3 months;
Pregnant or lactating female patients;