About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
Propofol
DrugUsing as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in propofol group.
ciprofol
DrugUsing as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in ciprofol group.
Treatment groups
Trial outcomes
Primary outcomes
the incidence of myocardial Injury after non-cardiac surgery
Myocardial injury after noncardiac surgery is defined by elevated postoperative cardiac troponin concentrations that exceed the 99th percentile of the upper reference limit of the assay and are attributable to a presumed ischemic mechanism, with or without concomitant symptoms or signs
Secondary outcomes
The proportion of new-onset atrial fibrillation
diagnosed by 12 lead ECG.
The proportion of new-onset atrial fibrillation
diagnosed by 12 lead ECG.
The proportion of new-onset non-atrial fibrillation arrhythmia
diagnosed by 12 lead ECG.
The incidence and duration of perioperative hypotension
assessing the effect of interventions on cardiovascular stability
Other outcomes
pain on injection of drugs
NRS was used to evaluate the pain intensity
the duration of bis>60 or bis <40
assessing the sedative effcacy and avoding intraoperative awareness
Spontaneous respiration recovery time
assessing the effect of interventions rescovery time
ermergence time
assessing the effect of interventions rescovery time
Sponsors and contacts
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