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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorTongji Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Propofol

    Drug

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

  • ciprofol

    Drug

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

Treatment groups

1,058 Participants
are divided into 2 treatment groups
Group A: ciprofol groupExperimental treatment 1 intervention
Group B: propofol groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Within the first 30 days after surgery

Secondary outcomes

1

The proportion of new-onset atrial fibrillation

diagnosed by 12 lead ECG.

Time frame
within hospitalized stay after anesthesia induction
2

The proportion of new-onset atrial fibrillation

diagnosed by 12 lead ECG.

Time frame
perioperatively
3

The proportion of new-onset non-atrial fibrillation arrhythmia

diagnosed by 12 lead ECG.

Time frame
perioperatively
4

The incidence and duration of perioperative hypotension

assessing the effect of interventions on cardiovascular stability

Time frame
between anesthesia induction and postoperative first 24 hour

Other outcomes

1

pain on injection of drugs

NRS was used to evaluate the pain intensity

Time frame
During anesthesisa induction
2

the duration of bis>60 or bis <40

assessing the sedative effcacy and avoding intraoperative awareness

Time frame
intraoperatively
3

Spontaneous respiration recovery time

assessing the effect of interventions rescovery time

Time frame
intraoperatively
4

ermergence time

assessing the effect of interventions rescovery time

Time frame
intraoperatively

Sponsors and contacts

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