Original scientific paper
Sevoflurane vs propofol in high risk cardiac surgery: design of the randomized trial “Sevo-Aifa”
Giovanni Landoni
orcid.org/0000-0002-8594-5980
; Department of Anesthesia and Intensive Care, Istituto Scientifico San Raffaele, Milano, Italia, Via Olgettina 60 Milano, 20132 Italy
Fabio Guarracino
; Cardiothoracic Department, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
Rubia Baldassarri
; Cardiothoracic Department, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
Claudia Cariello
; Cardiothoracic Department, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy
Chiara Gerli
; Department of Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italy, Via Olgettina 60 Milano, 20132 Italy
Greta Fano
; Department of Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italy, Via Olgettina 60 Milano, 20132 Italy
Francesco De Simone
; Department of Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italy, Via Olgettina 60 Milano, 20132 Italy
Luigi Cassarà
; Department of Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italy, Via Olgettina 60 Milano, 20132 Italy
Elena Frati
; Department of Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italy, Via Olgettina 60 Milano, 20132 Italy
Demetrio Pittarello
; Department of Cardiac Anesthesia, Padova, Italy
Luigi Tritapepe
; Dipartimento di Scienze Anestesiologiche, Medicina Critica e Terapia del Dolore, Università degli Studi “La Sapienza” di Roma, Italy
Alberto Zangrillo
; Department of Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italy, Via Olgettina 60 Milano, 20132 Italy
Abstract
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.
Keywords
anesthetic gases; cardiac surgical procedures; myocardium protection; sevoflurane; cardiac anesthesia; intensive care; volatile agents
Hrčak ID:
67482
URI
Publication date:
1.4.2011.
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