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Sevoflurane in Cardiac Surgery (SEVO AIFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821262
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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



Primary Outcome Measures :
  1. Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay

Secondary Outcome Measures :
  1. cardiac troponin release
  2. incidence of perioperative myocardial infarction
  3. time on mechanical ventilation
  4. postoperative hospital stay


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
Vita-Salute University
Milano, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Azienda Ospedaliera di Perugia (H Santa Maria della Misericordia)
Perugia, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Università La Sapienza, Policlinico Umberto I, Roma
Roma, Italy
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
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Principal Investigator: giovanni landoni, MD Vita-Salute University of Milano. Italy
Study Director: elena bignami, MD Vita-Salute University of Milano, Italy
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giovanni Landoni, DM, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT00821262    
Other Study ID Numbers: GO/URC/ER/mm 412/DG
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Giovanni Landoni, Università Vita-Salute San Raffaele:
Sevoflurane
Anesthesia
Troponin
Myocardial Preconditioning
Surgery, Cardiac
Stents
Non-cardiac Surgery
Surgery
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation