Desflurane vs. Propofol for Cardiac Anesthesia

NCT07116733 | Recruiting Phase 3 DMC

• 1 other identifier: KY20250104
• Study Type: interventional
• Target: 3,560
• Locations: 1 country
• Sites: 14

Brief Summary

To investigate whether the inhaled anesthetic desflurane, compared with propofol, exerts cardioprotective effects and reduces the incidence of severe postoperative major cardiac events in patients undergoing coronary artery bypass graft (CABG) surgery.

Conditions

Cardiac Surgery; Coronary Artery Bypass Grafting

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite outcome of death and major cardiac events

  It is composite outcome including: 1. All-cause mortality within 30 days postoperatively 2. New-onset acute heart failure, or any of the following: Cardiac arrest with successful resuscitation; Cardiogenic shock requiring mechanical circulatory support: Intra-aortic balloon pump (IABP), Extracorporeal membrane oxygenation (ECMO), Left ventricular assist device (e.g., Impella); Low cardiac output syndrome necessitating high-dose inotropic support (Inotropic Score (IS) \>15 within the first 24 postoperative hours, IS \>10 within 48 postoperative hours). 3. Arrhythmia requiring intervention: New-onset atrial fibrillation (pharmacotherapy or pacemaker),Other clinically significant arrhythmias. 4. Acute myocardial infarction 5. Emergency sternotomy/re-exploration for: Cardiac tamponade, Uncontrolled hemorrhage, Other life-threatening complications.

  within 30 days after operation

Secondary Outcomes (9)

• Incidence of death and the major cardiac events

  within 30 days after operation

• Total number of death and major cardiac events

  within 30 days after operation

• Length of mechanical ventilation

  within 30 days after operation

• Length of lCU stay

  From the date of surgery until the date patient discharge from hospital, assessed up to 1 year

• Incidence of pulmonary complications

  within 30 days after operation

Other Outcomes (7)

• SOFA score

  during postoperative ICU stay, with an average of 10 days

• The need for blood product transfusions

  from the day of surgery to hospital discharge, average for 7-10 days

• Volume of chest tube drainage

  within 72 hours following surgery

Study Arms (2)

Desflurane group

EXPERIMENTAL

After routine induction, anesthesia is maintained with inhaled desflurane, with the concentration adjusted as needed to maintain 0.5-2 MAC .Propofol is not used to maintain anesthesia during the whole anesthesia maintenance process, except during cardiopulmonary bypass.

Drug: Desflurane group

Propofol group

ACTIVE COMPARATOR

3-8 mg/kg/h intravenous infusion of propofol to implement total intravenous anesthesia maintenance, without the use of any inhaled anesthetic drugs, can be maintained by intravenous targeted infusion or manual adjustment of intravenous infusion.

Drug: Propofol group

Interventions

Desflurane group DRUG

After routine induction, maintain anesthesia with inhaled desflurane , adjusting concentration as needed to sustain 0.5-2 MAC . To maximize the cardioprotective effects of inhaled anesthetics, adhere to this intraoperative strategy: Maintain ≥1 MAC continuous desflurane for ≥30 minutes ; For on-pump CABG , discontinue desflurane 15 minutes before initiating cardiopulmonary bypass (CPB) ; If intraoperative desflurane cessation is required, implement a wash-in/wash-out strategy (recommended but non-mandatory): Perform 3 alternating cycles of: Wash-in : ≥10 minutes of desflurane at ≥0.5 MAC, Wash-out : ≥10 minutes of complete cessation of inhaled anesthetics. Propofol is strictly prohibited for anesthesia maintenance throughout the procedure , except during CPB.

Desflurane group

Propofol group DRUG

Administer total intravenous anesthesia (TIVA) using propofol infusion at 3-8 mg/kg/h . No inhaled anesthetics are permitted for maintenance. This may be delivered via:target-controlled infusion (TCI) systems, or manual adjustment of intravenous infusion rates.

Propofol group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Emergency or urgent operation
• Concomitant valve or aortic surgery
• History of myocardial infarction in recent 30 days
• Current use of myocardial preconditioning-affecting medications, such as sulfonylurea (glibenclamide), allopurinol, theophylline, nicorandil(last dose \< 8 hrs), etc
• Participated in other randomized controlled clinical trials in recent 3 months
• General anesthesia in recent 30 days
• 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)
• History of open heart surgery;
• 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%)
• Adverse drug reactions to trial medications
• History of malignant hyperthermia
• Pregnancy or lactation

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (14)

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, 710032, 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

Related Publications (8)

• Kampman JM, Hermanides J, Hollmann MW, Gilhuis CN, Bloem WA, Schraag S, Pradelli L, Repping S, Sperna Weiland NH. Mortality and morbidity after total intravenous anaesthesia versus inhalational anaesthesia: a systematic review and meta-analysis. EClinicalMedicine. 2024 May 14;72:102636. doi: 10.1016/j.eclinm.2024.102636. eCollection 2024 Jun.

  PMID: 38774674 BACKGROUND

• Qin H, Zhou J. Myocardial Protection by Desflurane: From Basic Mechanisms to Clinical Applications. J Cardiovasc Pharmacol. 2023 Sep 1;82(3):169-179. doi: 10.1097/FJC.0000000000001448.

  PMID: 37405905 BACKGROUND

• Zangrillo A, Lomivorotov VV, Pasyuga VV, Belletti A, Gazivoda G, Monaco F, Nigro Neto C, Likhvantsev VV, Bradic N, Lozovskiy A, Lei C, Bukamal NAR, Silva FS, Bautin AE, Ma J, Yong CY, Carollo C, Kunstyr J, Wang CY, Grigoryev EV, Riha H, Wang C, El-Tahan MR, Scandroglio AM, Mansor M, Lembo R, Ponomarev DN, Bezerra FJL, Ruggeri L, Chernyavskiy AM, Xu J, Tarasov DG, Navalesi P, Yavorovskiy A, Bove T, Kuzovlev A, Hajjar LA, Landoni G; MYRIAD Study Group. Effect of Volatile Anesthetics on Myocardial Infarction After Coronary Artery Surgery: A Post Hoc Analysis of a Randomized Trial. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2454-2462. doi: 10.1053/j.jvca.2022.01.001. Epub 2022 Jan 7.

  PMID: 35168907 BACKGROUND

• Landoni G, Lomivorotov VV, Nigro Neto C, Monaco F, Pasyuga VV, Bradic N, Lembo R, Gazivoda G, Likhvantsev VV, Lei C, Lozovskiy A, Di Tomasso N, Bukamal NAR, Silva FS, Bautin AE, Ma J, Crivellari M, Farag AMGA, Uvaliev NS, Carollo C, Pieri M, Kunstyr J, Wang CY, Belletti A, Hajjar LA, Grigoryev EV, Agro FE, Riha H, El-Tahan MR, Scandroglio AM, Elnakera AM, Baiocchi M, Navalesi P, Shmyrev VA, Severi L, Hegazy MA, Crescenzi G, Ponomarev DN, Brazzi L, Arnoni R, Tarasov DG, Jovic M, Calabro MG, Bove T, Bellomo R, Zangrillo A; MYRIAD Study Group. Volatile Anesthetics versus Total Intravenous Anesthesia for Cardiac Surgery. N Engl J Med. 2019 Mar 28;380(13):1214-1225. doi: 10.1056/NEJMoa1816476. Epub 2019 Mar 19.

  PMID: 30888743 BACKGROUND

• Han J, Ryu JH, Jeon YT, Koo CH. Comparison of Volatile Anesthetics Versus Propofol on Postoperative Cognitive Function After Cardiac Surgery: A Systematic Review and Meta-analysis. J Cardiothorac Vasc Anesth. 2024 Jan;38(1):141-147. doi: 10.1053/j.jvca.2023.09.038. Epub 2023 Oct 2.

  PMID: 37919165 BACKGROUND

• Jiang JL, Zhang L, He LL, Yu H, Li XF, Dai SH, Yu H. Volatile Versus Total Intravenous Anesthesia on Postoperative Delirium in Adult Patients Undergoing Cardiac Valve Surgery: A Randomized Clinical Trial. Anesth Analg. 2023 Jan 1;136(1):60-69. doi: 10.1213/ANE.0000000000006257. Epub 2022 Oct 27.

  PMID: 36301724 BACKGROUND

• Bonanni A, Signori A, Alicino C, Mannucci I, Grasso MA, Martinelli L, Deferrari G. Volatile Anesthetics versus Propofol for Cardiac Surgery with Cardiopulmonary Bypass: Meta-analysis of Randomized Trials. Anesthesiology. 2020 Jun;132(6):1429-1446. doi: 10.1097/ALN.0000000000003236.

  PMID: 32205551 BACKGROUND

• Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available.

  PMID: 30165632 BACKGROUND

Study Officials

• Chong Lei, M.D., phd

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chong Lei, M.D.& phd

CONTACT

18629011362; crystalleichong@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Chief of Anesthesia Clinical Research Center, Xijing Hospitall

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 12, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: beginning 12 morths after publication of the primary results
• Access Criteria: Investigators who provide a methodologically sound proposal and whose proposed use of data has been approved by the steering committee. For instance for using lPD data for meta- analysis. Proposals sholId be submitted to principle investigator and committee the trial. To gain access, data requestors will need to sign a data access agreement

Locations

CN (14)