Desflurane vs. Propofol for Cardiac Anesthesia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective coronary artery bypass grafting (CABG)
Age ≥ 18 years old;
Sign the informed consent form.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Desflurane group
DrugAfter 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.
Propofol group
DrugAdminister 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.
Treatment groups
3,560 Participants
are divided into 2 treatment groupsGroup A: Desflurane groupExperimental treatment 1 intervention
Group B: Propofol groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
within 30 days after operationSecondary outcomes
1
Incidence of death and the major cardiac events
the incidence of each component outcome in the primary outcome
Time frame
within 30 days after operation2
Total number of death and major cardiac events
Total number of events listed as the components of the primary outcomes.
Time frame
within 30 days after operation3
Length of mechanical ventilation
Length of mechanical ventilation in hours
Time frame
within 30 days after operation4
Length of lCU stay
Length of postoperative lCU stay
Time frame
From the date of surgery until the date patient discharge from hospital, assessed up to 1 yearOther outcomes
1
SOFA score
Daily SOFA scores during ICU stay
Time frame
during postoperative ICU stay, with an average of 10 days2
The need for blood product transfusions
The volume of RBCs, Platelet, FFP transfusion
Time frame
from the day of surgery to hospital discharge, average for 7-10 days3
Volume of chest tube drainage
Time frame
within 72 hours following surgery4
Requirement for vasoactive agents support for more than 48 hours
Time frame
at 48 hours following surgerySponsors and contacts
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Source ClinicalTrials.gov