Sevoflurane vs propofol in high risk cardiac surgery: design of the randomized trial "Sevo-Aifa"

Objective. Recent evidence indicates that volatile anesthetics improve post-ischemic recovery. In a meta-analysis of 22 randomized studies, the use of volatile anesthetics was associated with significant reduction in myocardial infarction and mortality. All the studies in this meta-analysis included low risk patients undergoing isolated procedures (mostly isolated coronary artery bypass grafting). We want to confirm the cardioprotective effects of volatile anesthetics, in cardiac surgery, as indicated by a reduced intensive care unit stay and/or death in a high risk population of patients, undergoing combined valvular and coronary procedures. Methods. Four centres will randomize 200 patients to receive either total intravenous anesthesia with propofol or anesthesia with sevoflurane. All patients will receive a standard average dose of opiates. Perioperative management will be otherwise identical and standardized. Transfer out of the intensive care unit will follow standard criteria. Results. Reduced cardiac damage will probably translate into better tissue perfusion and faster recovery, as documented by a reduced intensive care unit stay. The study is powered to detect a reduction in the composite end point of prolonged intensive care unit stay (>2days) and/or death from 60% to 40%. Conclusions. This will be the first multicentre randomized controlled trial comparing the effects of volatile anesthetics and total intravenous anesthesia in high risk patients undergoing cardiac procedures. Our trial should help clarify whether or not volatile agents should be recommended in high risk patients undergoing cardiac surgery.