Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
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|ClinicalTrials.gov Identifier: NCT01294163|
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.
This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.
The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease General Anesthetic Drug Allergy Coronary Artery Bypass Graft Surgery||Drug: Xenon Drug: Sevoflurane Drug: Propofol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||509 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety of Xenon Anaesthesia Compared to Sevoflurane Anaesthesia and Total Intravenous Anaesthesia for On-pump Coronary Artery Bypass Graft Surgery: a Randomised, Three-arm, Single-blind, International Study|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Inhaled xenon, maximal inspired concentration of 65%.
|Active Comparator: Sevoflurane||
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
|Active Comparator: Total intravenous anaesthesia||
Hourly dose of 2-4 mg/kg
- Blood Level of Troponin I [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]Blood level of troponin I measured by a central laboratory
- Log-transformed Blood Level of Troponin I [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]Blood level of troponin I measured by a central laboratory
- Depth of Anaesthesia [ Time Frame: 4 hours ]On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
- Arterial Oxygen Saturation [ Time Frame: 4 hours ]Arterial blood gases
- Haemodynamic Profile [ Time Frame: 4 hours ]Monitoring of heart rate, arterial blood pressure, central venous pressure.
- Presence or Absence of Postoperative Delirium [ Time Frame: 7 days ]Confusion Assessment Method
- Clinical Laboratory Tests [ Time Frame: 7 days ]
- ECG Abnormalities [ Time Frame: 7 days ]
- Vital Signs [ Time Frame: 7 days ]
- Presence of Absence of Adverse Events, Including Myocardial Infarction [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294163
|Principal Investigator:||Jan HOFLAND, MD, PhD||Thorax Centre Erasmus MC, Rotterdam, the Netherlands|