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Sevoflurane in Cardiac Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00821262
Acronym
SEVO AIFA
Enrollment
200
Registered
2009-01-13
Start date
2008-09-30
Completion date
2011-07-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cardiac Surgery

Keywords

Sevoflurane, Anesthesia, Troponin, Myocardial Preconditioning, Surgery, Cardiac, Stents, Non-cardiac Surgery, Surgery

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.

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.

Interventions

DRUGsevoflurane
DRUGpropofol

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay

Secondary

MeasureTime frame
cardiac troponin release
incidence of perioperative myocardial infarction
time on mechanical ventilation
postoperative hospital stay

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026