Myocardial InjuryPhase 4CP-MINSNCT07028593
Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery in Video-Assisted Thoracoscopic Surgery
A Phase 4 study testing Propofol and ciprofol in people with Myocardial Injury and Thoracic Diseases, run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Myocardial Injury, Thoracic Diseases, Thoracoscopic Surgery
- What is being tested?
- Propofol and ciprofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,058 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan
Shiyong Li, MD&phd
Ailin Luo, M.D.&PhD
About this study
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
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.
Read the detailed description
Lung cancer ranks first in both incidence and mortality among malignant tumors in China. In 2022, there were 1,060,600 new lung cancer cases, accounting for 22.0% of all malignant tumors, and 733,300 deaths, accounting for 28.5% of all malignant tumor deaths. Radical surgical resection is the recommended preferred treatment for stage I and II non-small cell lung cancer. Video-assisted thoracoscopic surgery (VATS) for anatomic lung resection has better safety and long-term efficacy than traditional surgical methods, with more than 73.7% of lung cancer surgeries in China using thoracoscopic approaches. Thoracic surgery easily induces significant perioperative hemodynamic fluctuations, increasing the risk of perioperative cardiovascular and cerebrovascular complications, thus posing great challenges to perioperative anesthetic safety and long-term patient outcomes.
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; the COP-AF study found that the incidence of MINS in non-cardiac thoracic surgery is 20.3% . 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.
Severe hemodynamic fluctuations are one of the important causes of perioperative induction of MINS, thus maintaining hemodynamic stability is a critical step to reduce MINS. Propofol is the most commonly used drug for anesthesia induction and maintenance in clinical practice, with advantages such as rapid onset, strong sedative efficacy, and quick recovery. However, due to its significant circulatory inhibitory effects, the incidence of intraoperative hypotension induced and maintained by propofol in patients without cardiovascular diseases is 25%-40%, increasing the risk of perioperative hypotension and adverse cardiovascular events, which poses great challenges to anesthetic management. Additionally, 80% of patients receiving propofol experience injection pain of varying degrees, which also reduces patient comfort during treatment. Therefore, developing a sedative with both good sedative efficacy and no or low circulatory inhibition has long been a desirable goal for anesthesiologists.
Ciprofol is a Class 1 innovative drug independently developed in China with global intellectual property rights. Its molecular structure is an analog of propofol (2,6-diisopropylphenol). Both Ciprofol and propofol act on γ-aminobutyric acid type A (GABA-A) receptors, causing hyperpolarization of GABAergic neurons, reducing the success rate of action potential generation, and achieving inhibition of the central nervous system to produce short and rapid sedative or anesthetic effects. Pharmacologically, Ciprofol not only retains the characteristics of propofol such as rapid onset, rapid elimination, and high sedative efficacy but also has a higher drug cost-effectiveness ratio and therapeutic index (in mouse experiments, the median effective dose for sedation of Ciprofol is 1.5 mg/kg, the median lethal dose is 9.9 mg/kg, and the therapeutic index is 6.6, while that of propofol is only 2.8). Furthermore, due to the lower drug concentration in the aqueous phase of the Ciprofol emulsion, the risk of injection pain is much lower than that of propofol, improving treatment comfort. 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 post-marketing 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.
After data collection, full Analysis Set (FAS): A population derived by minimally and reasonably excluding certain cases under the principle of Intention-to-Treat (ITT), where cases included in the FAS should not seriously violate the inclusion criteria. FAS will be used for the analysis of baseline data and primary efficacy endpoints.
Per-Protocol Set (PPS): All cases that comply with the trial protocol, are well-tolerated (patients who completed PED procedures), and have completed the content specified in the case report form. PPS is used for the analysis of primary efficacy endpoints.
Safety Set (SS): Refers to the actual data of subjects who received at least one dose of treatment after randomization and have recorded safety indicators.
- Conditions
- Myocardial Injury, Thoracic Diseases, Thoracoscopic Surgery
- Being tested
- Propofol, ciprofol
- Keywords
- Myocardial Injury after non-cardiac surgery, Ciprofol, propofol, Video-Assisted Thoracoscopic Surgery, lung tumor
- Medical subject headings
- Thoracic Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Using as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in propofol group.
ciprofolDrug
Also called HSK3486
Using as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in ciprofol group.
| Study group | Role | What they receive |
|---|---|---|
| ciprofol group | Experimental | 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. Receives: Drug: ciprofol |
| propofol group | Active comparator | 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within the first 30 days after surgery
Secondary outcomes (6)
The proportion of new-onset atrial fibrillation
diagnosed by 12 lead ECG.
Measured: within hospitalized stay after anesthesia induction
The proportion of new-onset atrial fibrillation
diagnosed by 12 lead ECG.
Measured: perioperatively
The proportion of new-onset non-atrial fibrillation arrhythmia
diagnosed by 12 lead ECG.
Measured: perioperatively
The incidence and duration of perioperative hypotension
assessing the effect of interventions on cardiovascular stability
Measured: between anesthesia induction and postoperative first 24 hour
30-day postoperative mortality rate
assessing the survival outcome
Measured: Within the first 30 days after surgery
New-onset myocardial infarction
assessing the cardiovascular complications
Measured: Within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start31 Jul 2025
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,058 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ailin Luo, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028593
- Sponsor's protocol ID
- TJ-IRB202502133
- Acronym
- CP-MINS
- Status last verified
- Jan 2026
- First submitted
- 29 May 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thygesen 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.
PubMed 30571511Lopez 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.
PubMed 38163371Conen 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.
PubMed 37640035Zucker 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.
PubMed 35869445de 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.
PubMed 27199311Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.
PubMed 21406529Gan TJ, Bertoch T, Habib AS, Yan P, Zhou R, Lai YL, Liu X, Essandoh M, Daley WL, Gelb AW. Comparison of the Efficacy of HSK3486 and Propofol for Induction of General Anesthesia in Adults: A Multicenter, Randomized, Double-blind, Controlled, Phase 3 Noninferiority Trial. Anesthesiology. 2024 Apr 1;140(4):690-700. doi: 10.1097/ALN.0000000000004886.
PubMed 38150544Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.
PubMed 28430430Liang P, Dai M, Wang X, Wang D, Yang M, Lin X, Zou X, Jiang K, Li Y, Wang L, Shangguan W, Ren J, He H. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):399-406. doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19.
PubMed 36647565Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
PubMed 35302207Zeng Y, Wang DX, Lin ZM, Liu J, Wei XC, Deng J, Liu YF, Ma EL, Yang MC, Zheng H, Yu XD, Guo QL, Guan YJ. Efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients: a multicenter, randomized, open-label, propofol-controlled phase 2 clinical trial. Eur Rev Med Pharmacol Sci. 2022 Feb;26(4):1114-1124. doi: 10.26355/eurrev_202202_28101.
PubMed 35253166Liu Y, Yu X, Zhu D, Zeng J, Lin Q, Zang B, Chen C, Liu N, Liu X, Gao W, Guan X. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J (Engl). 2022 May 5;135(9):1043-1051. doi: 10.1097/CM9.0000000000001912.
PubMed 34924506Luo Z, Tu H, Zhang X, Wang X, Ouyang W, Wei X, Zou X, Zhu Z, Li Y, Shangguan W, Wu H, Wang Y, Guo Q. Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study. CNS Drugs. 2022 Mar;36(3):301-313. doi: 10.1007/s40263-021-00890-1. Epub 2022 Feb 14.
PubMed 35157236Li J, Wang X, Liu J, Wang X, Li X, Wang Y, Ouyang W, Li J, Yao S, Zhu Z, Guo Q, Yu Y, Meng J, Zuo Y. Comparison of ciprofol (HSK3486) versus propofol for the induction of deep sedation during gastroscopy and colonoscopy procedures: A multi-centre, non-inferiority, randomized, controlled phase 3 clinical trial. Basic Clin Pharmacol Toxicol. 2022 Aug;131(2):138-148. doi: 10.1111/bcpt.13761. Epub 2022 Jun 10.
PubMed 35653554Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
PubMed 34116176
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07028593
- Acronym / sponsor ID
- CP-MINS / TJ-IRB202502133
- Conditions
- Myocardial Injury, Thoracic Diseases, Thoracoscopic Surgery
- Keywords
- Myocardial Injury after non-cardiac surgery, Ciprofol, propofol, Video-Assisted Thoracoscopic Surgery, lung tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,058 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung cancer ranks first in both incidence and mortality among malignant tumors in China. In 2022, there were 1,060,600 new lung cancer cases, accounting for 22.0% of all malignant tumors, and 733,300 deaths, accounting for 28.5% of all malignant tumor deaths. Radical surgical resection is the recommended preferred treatment for stage I and II non-small cell lung cancer. Video-assisted thoracoscopic surgery (VATS) for anatomic lung resection has better safety and long-term efficacy than traditional surgical methods, with more than 73.7% of lung cancer surgeries in China using thoracoscopic approaches. Thoracic surgery easily induces significant perioperative hemodynamic fluctuations, increasing the risk of perioperative cardiovascular and cerebrovascular complications, thus posing great challenges to perioperative anesthetic safety and long-term patient outcomes.
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; the COP-AF study found that the incidence of MINS in non-cardiac thoracic surgery is 20.3% . 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.
Severe hemodynamic fluctuations are one of the important causes of perioperative induction of MINS, thus maintaining hemodynamic stability is a critical step to reduce MINS. Propofol is the most commonly used drug for anesthesia induction and maintenance in clinical practice, with advantages such as rapid onset, strong sedative efficacy, and quick recovery. However, due to its significant circulatory inhibitory effects, the incidence of intraoperative hypotension induced and maintained by propofol in patients without cardiovascular diseases is 25%-40%, increasing the risk of perioperative hypotension and adverse cardiovascular events, which poses great challenges to anesthetic management. Additionally, 80% of patients receiving propofol experience injection pain of varying degrees, which also reduces patient comfort during treatment. Therefore, developing a sedative with both good sedative efficacy and no or low circulatory inhibition has long been a desirable goal for anesthesiologists.
Ciprofol is a Class 1 innovative drug independently developed in China with global intellectual property rights. Its molecular structure is an analog of propofol (2,6-diisopropylphenol). Both Ciprofol and propofol act on γ-aminobutyric acid type A (GABA-A) receptors, causing hyperpolarization of GABAergic neurons, reducing the success rate of action potential generation, and achieving inhibition of the central nervous system to produce short and rapid sedative or anesthetic effects. Pharmacologically, Ciprofol not only retains the characteristics of propofol such as rapid onset, rapid elimination, and high sedative efficacy but also has a higher drug cost-effectiveness ratio and therapeutic index (in mouse experiments, the median effective dose for sedation of Ciprofol is 1.5 mg/kg, the median lethal dose is 9.9 mg/kg, and the therapeutic index is 6.6, while that of propofol is only 2.8). Furthermore, due to the lower drug concentration in the aqueous phase of the Ciprofol emulsion, the risk of injection pain is much lower than that of propofol, improving treatment comfort. 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 post-marketing 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.
After data collection, full Analysis Set (FAS): A population derived by minimally and reasonably excluding certain cases under the principle of Intention-to-Treat (ITT), where cases included in the FAS should not seriously violate the inclusion criteria. FAS will be used for the analysis of baseline data and primary efficacy endpoints.
Per-Protocol Set (PPS): All cases that comply with the trial protocol, are well-tolerated (patients who completed PED procedures), and have completed the content specified in the case report form. PPS is used for the analysis of primary efficacy endpoints.
Safety Set (SS): Refers to the actual data of subjects who received at least one dose of treatment after randomization and have recorded safety indicators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciprofol group | Experimental | Drug: ciprofolSlowly 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. |
| propofol group | Active comparator | Drug: PropofolSlowly 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolUsing as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in propofol group. | Drug | propofol group |
| ciprofolAlso: HSK3486Using as sedative agents in the total intravenous anesthesia in video-assisted thoracoscopic aurgery in ciprofol group. | Drug | ciprofol group |
Primary outcome
the incidence of myocardial Injury after non-cardiac surgery
Time frame: Within the first 30 days after 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
6 secondary outcomes
The proportion of new-onset atrial fibrillation
Time frame: within hospitalized stay after anesthesia induction
The proportion of new-onset atrial fibrillation
Time frame: perioperatively
The proportion of new-onset non-atrial fibrillation arrhythmia
Time frame: perioperatively
The incidence and duration of perioperative hypotension
Time frame: between anesthesia induction and postoperative first 24 hour
30-day postoperative mortality rate
Time frame: Within the first 30 days after surgery
New-onset myocardial infarction
Time frame: Within the first 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 30571511Thygesen 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.
- Background: PubMed 38163371Lopez 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.
- Background: PubMed 37640035Conen 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.
- Background: PubMed 35869445Zucker 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.
- Background: PubMed 27199311de 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.
- Background: PubMed 21406529Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.
- Background: PubMed 38150544Gan TJ, Bertoch T, Habib AS, Yan P, Zhou R, Lai YL, Liu X, Essandoh M, Daley WL, Gelb AW. Comparison of the Efficacy of HSK3486 and Propofol for Induction of General Anesthesia in Adults: A Multicenter, Randomized, Double-blind, Controlled, Phase 3 Noninferiority Trial. Anesthesiology. 2024 Apr 1;140(4):690-700. doi: 10.1097/ALN.0000000000004886.
- Background: PubMed 28430430Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.
- Background: PubMed 36647565Liang P, Dai M, Wang X, Wang D, Yang M, Lin X, Zou X, Jiang K, Li Y, Wang L, Shangguan W, Ren J, He H. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):399-406. doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19.
- Background: PubMed 35302207Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
- Background: PubMed 35253166Zeng Y, Wang DX, Lin ZM, Liu J, Wei XC, Deng J, Liu YF, Ma EL, Yang MC, Zheng H, Yu XD, Guo QL, Guan YJ. Efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients: a multicenter, randomized, open-label, propofol-controlled phase 2 clinical trial. Eur Rev Med Pharmacol Sci. 2022 Feb;26(4):1114-1124. doi: 10.26355/eurrev_202202_28101.
- Background: PubMed 34924506Liu Y, Yu X, Zhu D, Zeng J, Lin Q, Zang B, Chen C, Liu N, Liu X, Gao W, Guan X. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J (Engl). 2022 May 5;135(9):1043-1051. doi: 10.1097/CM9.0000000000001912.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and ciprofol in people with Myocardial Injury and Thoracic Diseases, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ailin Luo, MD&PhD (13507122565, alluo@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of myocardial Injury after non-cardiac surgery (time frame: Within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07028593, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.