Ciprofol to reduce heart injury after VATS lung 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
This trial tests whether using ciprofol instead of propofol during general anesthesia for adults having VATS lung or mediastinal surgery can lower the chance of postoperative heart injury (MINS).
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1058 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT07028593 on ClinicalTrials.gov |
What this trial studies
Adults aged 45–80 scheduled for elective video-assisted thoracoscopic lung or mediastinal surgery receive general anesthesia with either ciprofol or propofol and are monitored during and after surgery. The study tracks postoperative cardiac troponin levels to identify myocardial injury (MINS), along with perioperative hemodynamics and clinical outcomes. Key exclusions include known allergy to study drugs, unstable angina or heart failure needing vasopressors, severe COPD, severe renal or hepatic dysfunction, and pregnancy or lactation. The trial is conducted at Tongji Hospital in Wuhan with participants expected to remain hospitalized for at least three days for postoperative monitoring.
Who should consider this trial
Good fit: Adults 45–80 years old scheduled for elective VATS anatomical lung resection or mediastinal tumor resection with an expected postoperative stay of three days or more who can give informed consent.
Not a fit: Patients with unstable angina, congestive heart failure requiring vasopressors, severe COPD, severe renal or hepatic impairment, allergy to propofol/ciprofol or related excipients, and pregnant or breastfeeding patients are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, using ciprofol could reduce the incidence of MINS and lower short- and long-term cardiovascular complications after VATS procedures.
How similar studies have performed: Previous anesthesia trials indicate ciprofol provides comparable sedation to propofol with possibly less hemodynamic depression, but its specific effect on postoperative MINS has not been well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Wuhan
- Tongji hospital — Wuhan, China (Recruiting)
Study contacts
- Study coordinator: Ailin Luo, MD&PhD
- Email: alluo@tjh.tjmu.edu.cn
- Phone: 13507122565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.