Desflurane versus propofol anesthesia for coronary artery bypass surgery

Desflurane vs. Propofol for Cardiac Anesthesia: Impact on Developing Major Cardiac Events in Patients Undergoing CABG Procedure

This study will test whether using the inhaled anesthetic desflurane instead of propofol during anesthesia reduces serious postoperative cardiac complications in adults having coronary artery bypass graft surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3560 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 14 sites (Fuzhou, Fujian and 13 other locations)
• Trial ID: NCT07116733 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter randomized interventional trial compares desflurane-based inhaled anesthesia with propofol-based total intravenous anesthesia in adults undergoing elective CABG. Participants are adults scheduled for isolated CABG who meet inclusion criteria and do not have recent MI, combined valve/aortic procedures, or severe organ dysfunction. The primary outcome is the incidence of severe postoperative major cardiac events and other perioperative complications, with standardized perioperative management across sites. The study is being run at multiple hospitals in China to capture real-world surgical populations and outcomes.

Who should consider this trial

Good fit: Adults (≥18 years) scheduled for elective isolated CABG who can give informed consent and do not have recent myocardial infarction, concurrent valve/aortic surgery, severe liver or kidney dysfunction, prior open-heart surgery, or interfering medications are ideal candidates.

Not a fit: Patients having emergency/urgent operations, combined valve or aortic procedures, recent MI, severe organ failure, prior open-heart surgery, hemodynamic instability, or taking medications that affect myocardial preconditioning are excluded and unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, using desflurane could lower rates of major postoperative cardiac events and improve recovery and short-term outcomes after CABG.

How similar studies have performed: Some prior studies and observational data have suggested volatile anesthetics may provide myocardial protection, but results are mixed and definitive large randomized Phase 3 evidence is limited.

Eligibility criteria

Inclusion Criteria:

1. Patients scheduled for elective coronary artery bypass grafting (CABG)
2. Age ≥ 18 years old;
3. Sign the informed consent form.

Exclusion Criteria:

1. Emergency or urgent operation
2. Concomitant valve or aortic surgery
3. History of myocardial infarction in recent 30 days
4. Current use of myocardial preconditioning-affecting medications, such as sulfonylurea (glibenclamide), allopurinol, theophylline, nicorandil(last dose \< 8 hrs), etc
5. Participated in other randomized controlled clinical trials in recent 3 months
6. General anesthesia in recent 30 days
7. History of kidney and liver transplantation, or severe liver and kidney dysfunction (EGFR ≤ 20 mlgmin/1.73 m2, conventional dialysis or patients who have started dialysis; Child Pugh grade C/cirrhosis)
8. History of open heart surgery;
9. Hemodynamic instability or severe heart failure (SBP\<90 mmHg or preoperative need of high-dose vasoactive drug support, placement of aortic balloon pump (IABP), ECMO or ventricular assist device, left ventricular ejection fraction\<30%)
10. Adverse drug reactions to trial medications
11. History of malignant hyperthermia
12. Pregnancy or lactation

Where this trial is running

Fuzhou, Fujian and 13 other locations

• Fuzhou University Affiliated Provincial Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Cangzhou People's Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• Hebei General Hospital — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Wuhan Asia Heart Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjin, Jiangsu, China (Not_yet_recruiting)
• Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Tianjin Chest Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Ningbo No.2 Hospital — Ningbo, Zhejiang, China (Not_yet_recruiting)
• Daping Hospital, Army Medical University — Chongqing, China (Not_yet_recruiting)
• Changhai Hospital — Shanghai, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Chong Lei, M.D., phd — Xijing Hospital
• Study coordinator: Chong Lei, M.D.& phd

Conditions Cardiac Surgery; Coronary Artery Bypass Grafting; Desflurane; Propofol; Major Cardiac Event