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RECRUITING
NCT07028593
PHASE4

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

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1058

Start Date

2025-07-31

Completion Date

2027-12

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

Propofol

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

DRUG

ciprofol

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

Locations (1)

Tongji hospital

Wuhan, China