Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

Study Overview
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Brief Summary
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There is initial evidence that the choice of anesthesia can influence survival in the specific setting of coronary artery bypass grafting surgery (CABG). A recent international consensus conference included volatile agents among the few drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin release and mortality in patients receiving volatile anesthetics when compared to patients receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can translate into a reduced mortality rate in patients receiving volatile agents. The level of evidence for these four studies is not high (one meta-regression, one underpowered randomized controlled study, one retrospective study and one meta-analysis of small randomized studies) and there is need for a large multicentre randomized controlled study to confirm these findings, as suggested by the international consensus conference on this topic published in 2011 (Landoni et al 2011). The purpose is to provide a large multicentre controlled randomized trial to demonstrate that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass). The results of this study can support the use of volatile agents in all CABG procedures worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be reduced from 3% to 2% using volatile agents).

Official Title
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Volatile Anesthetics to Reduce Mortality in Cardiac Surgery: A Multicentre Randomized Controlled Study

Conditions
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Aortocoronary Bypass, Cardiac Surgery, Coronary Artery Bypass Grafting

Intervention / Treatment
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* Drug: desflurane, isoflurane, sevoflurane
* Drug: total intravenous anesthetics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years written informed consent scheduled procedures planned isolated CABG (multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed Exclusion Criteria: pregnancy planned valve surgery or surgery on the aorta planned locoregional anesthesia without general anesthesia unstable or ongoing angina recent (< 1 month) or ongoing acute myocardial infarction use of sulfonylurea, theophylline or allopurinol previous unusual response to an anesthetic agent inclusion in other randomised controlled studies in the previous 30 days any general anesthesia performed in the previous 30 days emergency operation (not scheduled) Kidney or liver transplant in medical history Liver cirrhosis (Child B or C)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volatile anesthetics (desflurane, isoflurane, sevoflurane)<br> | Drug: desflurane, isoflurane, sevoflurane<br> <br> |
| Active Comparator: total intravenous anesthesia<br> | Drug: total intravenous anesthetics<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volatile anesthetics, desflurane, isoflurane, sevoflurane, TIVA, cardiac surgery, mortality, anesthesia, intensive care