Sevoflurane in Cardiac Surgery (SEVO AIFA)
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|ClinicalTrials.gov Identifier: NCT00821262|
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : October 14, 2015
Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.
The investigators want to document whether the cardioprotective properties of volatile agents could translate in an improved outcome after cardiac surgery in high risk patients.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Cardiac Surgery||Drug: sevoflurane Drug: propofol||Phase 4|
It is commonly believed that the choice of the primary anesthetic agent does not result in different outcomes after cardiac surgery. Recent evidence however has indicated that volatile anesthetics improve post-ischemic recovery. These results have been summarized in a meta-analysis of 22 randomized studies, involving 1922 patients: the use of volatile anesthetics was associated with significant reductions of myocardial infarctions (24/979 [2.4%] in the volatile anesthetics group vs 45/874 [5.1%] in the control arm, odds ratio [OR]=0.51 [0.32-0.84], and mortality (4/977 [0.4%] vs 14/872 [1.6%], OR=0.31 [0.12-0.80].
Furthermore, the use of volatile anesthetics was associated with shorter intensive-care unit stay (WMD=-7.10 hours [-11.47; -2.73], and time to hospital discharge (WMD=-2.26 days [-3.83; -0.68].
All the studies of the meta-analysis included low risk patients undergoing isolated procedures (mostly coronary artery bypass grafting).
Investigators are planning a large multicentre randomized controlled study to confirm the beneficial cardioprotective effects of volatile anesthetics in cardiac surgery as indicated by a reduced intensive care stay and/or death in an high risk population of patients undergoing combined valvular and coronary procedures. Secondary endpoints will be: cardiac troponin release; incidence of myocardial infarction; time on mechanical ventilation; postoperative hospital stay
Various centers will randomize 200 patients to receive either a total intravenous anesthesia with propofol or an anesthesia with sevoflurane. All patients will receive a standard middle dose opiates anesthesia. All the perioperative management will be otherwise identical and standardized. Transfer out of the intensive care will be performed with SpO2 94% or greater at an FiO2 of 0.5 or less by facemask, adequate cardiac stability with no hemodynamically significant arrhythmias, chest tube drainage less than 50 ml/h, urine output greater than 0.5 ml/kg/h, no intravenous inotropic or vasopressor therapy in excess of dopamine 5 ug/kg/min, and no seizure activity.
The reduced cardiac damage (reduction in cardiac troponin release and in the incidence of myocardial infarction) will translate into a better tissue perfusion and faster recovery as documented by reduced intensive care unit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Sevoflurane and Cardiac Protection in High Risk Patients Undergoing Cardiac Surgery. A Randomized Controlled Study.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).
Active Comparator: propofol
The control group will receive propofol for the same 4-6 hours period.
- Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay
- cardiac troponin release
- incidence of perioperative myocardial infarction
- time on mechanical ventilation
- postoperative hospital stay
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): NCT00821262
|Azienda Ospedaliera di Padova|
|Azienda Ospedaliera di Perugia (H Santa Maria della Misericordia)|
|Azienda Ospedaliera Universitaria Pisana|
|Università La Sapienza, Policlinico Umberto I, Roma|
|Principal Investigator:||giovanni landoni, MD||Vita-Salute University of Milano. Italy|
|Study Director:||elena bignami, MD||Vita-Salute University of Milano, Italy|