SEVO AIFA: Sevoflurane in Cardiac Surgery

Sponsor

Università Vita-Salute San Raffaele (Other)

Overall Status

Completed

CT.gov ID

NCT00821262

Collaborator

(none)

200

Enrollment

Locations

Arms

33.9

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Detailed Description

Background

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).

Objectives

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

Methods

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.

Expected Results

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Sevoflurane and Cardiac Protection in High Risk Patients Undergoing Cardiac Surgery. A Randomized Controlled Study.

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sevoflurane The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).	Drug: sevoflurane
Active Comparator: propofol The control group will receive propofol for the same 4-6 hours period.	Drug: propofol

Arm

Intervention/Treatment

Experimental: sevoflurane

The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).

Drug: sevoflurane

Active Comparator: propofol

The control group will receive propofol for the same 4-6 hours period.

Drug: propofol

Outcome Measures

Primary Outcome Measures

Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay []

Secondary Outcome Measures

cardiac troponin release []
incidence of perioperative myocardial infarction []
time on mechanical ventilation []
postoperative hospital stay []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age >18 years
written informed consent
scheduled procedures

Exclusion Criteria:

ongoing acute myocardial infarction
cardiac troponin >1 ng/ml
previous unusual response to an anesthetic
use of sulfonylurea, theophylline or allopurinol
thoracotomy

Contacts and Locations

Locations

	Site	City	Country
1	Vita-Salute University	Milano	Italy
2	Azienda Ospedaliera di Padova	Padova	Italy
3	Azienda Ospedaliera di Perugia (H Santa Maria della Misericordia)	Perugia	Italy
4	Azienda Ospedaliera Universitaria Pisana	Pisa	Italy
5	Università La Sapienza, Policlinico Umberto I, Roma	Roma	Italy

Sponsors and Collaborators

Università Vita-Salute San Raffaele

Investigators

Principal Investigator: giovanni landoni, MD, Vita-Salute University of Milano. Italy
Study Director: elena bignami, MD, Vita-Salute University of Milano, Italy