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

NCT07028593 | Recruiting Phase 4

• 1 other identifier: TJ-IRB202502133
• Study Type: interventional
• Target: 1,058
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Injury; Thoracic Diseases; Thoracoscopic Surgery

Keywords

Myocardial Injury after non-cardiac surgery; Ciprofol; propofol; Video-Assisted Thoracoscopic Surgery; lung tumor

Outcome Measures

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

  Within the first 30 days after surgery

Secondary Outcomes (6)

• The proportion of new-onset atrial fibrillation

  within hospitalized stay after anesthesia induction

• The proportion of new-onset atrial fibrillation

  perioperatively

• The proportion of new-onset non-atrial fibrillation arrhythmia

  perioperatively

• The incidence and duration of perioperative hypotension

  between anesthesia induction and postoperative first 24 hour

• 30-day postoperative mortality rate

  Within the first 30 days after surgery

Other Outcomes (11)

• pain on injection of drugs

  During anesthesisa induction

• the duration of bis>60 or bis <40

  intraoperatively

• Spontaneous respiration recovery time

  intraoperatively

Study Arms (2)

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.

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.

Drug: Propofol

Interventions

Propofol DRUG

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

propofol group

ciprofol DRUG

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

Also known as: HSK3486

ciprofol group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, China

RECRUITING

Related Publications (17)

• 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.

  PMID: 30571511 BACKGROUND

• Lopez 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 BACKGROUND

• Conen 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 BACKGROUND

• Zucker 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 BACKGROUND

• de 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.

  PMID: 27199311 BACKGROUND

• Jalota 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.

  PMID: 21406529 BACKGROUND

• Gan 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.

  PMID: 38150544 BACKGROUND

• Qin 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.

  PMID: 28430430 BACKGROUND

• Liang 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.

  PMID: 36647565 BACKGROUND

• Wang 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.

  PMID: 35302207 BACKGROUND

• Zeng 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.

  PMID: 35253166 BACKGROUND

• Liu 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.

  PMID: 34924506 BACKGROUND

• Luo 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.

  PMID: 35157236 BACKGROUND

• Li 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.

  PMID: 35653554 BACKGROUND

• Teng 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.

  PMID: 34116176 BACKGROUND

• Puelacher C, Lurati Buse G, Seeberger D, Sazgary L, Marbot S, Lampart A, Espinola J, Kindler C, Hammerer A, Seeberger E, Strebel I, Wildi K, Twerenbold R, du Fay de Lavallaz J, Steiner L, Gurke L, Breidthardt T, Rentsch K, Buser A, Gualandro DM, Osswald S, Mueller C; BASEL-PMI Investigators. Perioperative Myocardial Injury After Noncardiac Surgery: Incidence, Mortality, and Characterization. Circulation. 2018 Mar 20;137(12):1221-1232. doi: 10.1161/CIRCULATIONAHA.117.030114. Epub 2017 Dec 4.

  PMID: 29203498 RESULT

• Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and Management of Patients With Myocardial Injury After Noncardiac Surgery: A Scientific Statement From the American Heart Association. Circulation. 2021 Nov 9;144(19):e287-e305. doi: 10.1161/CIR.0000000000001024. Epub 2021 Oct 4.

  PMID: 34601955 RESULT

MeSH Terms

Conditions

Thoracic Diseases; Lung Neoplasms

Interventions

Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; HSK3486

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ailin Luo, MD&PhD

CONTACT

13507122565; alluo@tjh.tjmu.edu.cn

Shiyong Li, MD&PhD

CONTACT

15002780081; shiyongli@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study blinded the efficacy assessors (rather than the anesthesiologists administering the anesthesia) and the participants, with the double-blind status maintained throughout the study period. 1. Blinding of efficacy assessors: In this study, a designated study coordinator was responsible for maintaining and distributing randomization numbers, preparing study drugs, and coordinating information among anesthesiologists. Anesthesiologists completed preoperative visits and collected preoperative patient data; efficacy evaluators were only responsible for patient follow-up and data entry of postoperative test results, without participating in the process of anesthesia administration or management. Anesthesiologists administered drugs based on patients' body weights. 2. Blinding of participants: participants were unaware of their group assignments and medication administration during the study period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 19, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)