Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myocardial Injury | — | UNRESOLVED | — |
| Thoracic Diseases | — | UNRESOLVED | — |
| Thoracoscopic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ciprofol | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ciprofol group
- description
- Slowly administer sufentanil 0.2 μg/kg to 0.7 μg/kg via intravenous injection; cis-atracurium 0.15 mg/kg to 0.20 mg/kg; Ciprofol 0.4 ml/kg to 0.6 ml/kg via slow intravenous injection. The injection time for all drugs is 2 minutes.
- interventionNames
- Drug: ciprofol
- type
- ACTIVE_COMPARATOR
- label
- propofol group
- description
- Slowly administer sufentanil 0.2 μg/kg to 0.7 μg/kg via intravenous injection; cis-atracurium 0.15 mg/kg to 0.20 mg/kg; propofol injection 0.1 ml/kg to 0.25 ml/kg slowly via intravenous injection. The injection time for all drugs is 2 minutes.
- interventionNames
- Drug: Propofol
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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; 2. Aged 45 to 80 years (inclusive) at the time of randomization; 3. Expected postoperative hospital stay of ≥3 days; 4. Signed a written informed consent to participate in the study. Exclusion Criteria: 1. Patients allergic to propofol, Ciprofol, or analogs of drug excipient components (soybeans, eggs, milk); 2. Patients with unstable angina; 3. Patients with congestive heart failure or hemodynamic instability requiring vasopressor agents; 4. Patients with severe COPD (FEV1 \< 1 L); 5. Glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m²; 6. Patients with severe hepatic dysfunction (ALT or AST elevation exceeding 1.5 times the upper limit of normal); 7. Male or female patients planning to conceive within the next 3 months; 8. Pregnant or lactating female patients;
References
Publications (17)
- BACKGROUNDThygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available. PMID 30571511
- BACKGROUNDLopez J, Borzak S. In noncardiac thoracic surgery, low-dose colchicine did not reduce AF or myocardial injury after noncardiac surgery at 14 d. Ann Intern Med. 2024 Jan;177(1):JC3. doi: 10.7326/J23-0103. Epub 2024 Jan 2. PMID 38163371
- BACKGROUNDConen D, Ke Wang M, Popova E, Chan MTV, Landoni G, Cata JP, Reimer C, McLean SR, Srinathan SK, Reyes JCT, Grande AM, Tallada AG, Sessler DI, Fleischmann E, Kabon B, Voltolini L, Cruz P, Maziak DE, Gutierrez-Soriano L, McIntyre WF, Tandon V, Martinez-Tellez E, Guerra-Londono JJ, DuMerton D, Wong RHL, McGuire AL, Kidane B, Roux DP, Shargall Y, Wells JR, Ofori SN, Vincent J, Xu L, Li Z, Eikelboom JW, Jolly SS, Healey JS, Devereaux PJ; COP-AF Investigators. Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial. Lancet. 2023 Nov 4;402(10413):1627-1635. doi: 10.1016/S0140-6736(23)01689-6. Epub 2023 Aug 25. PMID 37640035
- BACKGROUNDZucker M, Kagan G, Adi N, Ronel I, Matot I, Zac L, Goren O. Changes in mean systemic filling pressure as an estimate of hemodynamic response to anesthesia induction using propofol. BMC Anesthesiol. 2022 Jul 22;22(1):234. doi: 10.1186/s12871-022-01773-8. PMID 35869445
- BACKGROUNDde Wit F, van Vliet AL, de Wilde RB, Jansen JR, Vuyk J, Aarts LP, de Jonge E, Veelo DP, Geerts BF. The effect of propofol on haemodynamics: cardiac output, venous return, mean systemic filling pressure, and vascular resistances. Br J Anaesth. 2016 Jun;116(6):784-9. doi: 10.1093/bja/aew126.