Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

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. Identifier: NCT00484575
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : May 20, 2010
Information provided by:
Karolinska Institutet

Brief Summary:

Inhaled sevoflurane during coronary artery bypass grafting (CABG) reduces postoperative Troponin levels and may be associated with improved outcome. A dose-response effect has been demonstrated by de Hert et al, with greatest reductions of Troponin when Sevoflurane was used during the entire operation, as compared to Sevoflurane during parts of the operation.

Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. Postoperative sedation after CABG is currently achieved with intravenous propofol.

A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group. The Anesthetic Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.

The primary aim (and primary hypothesis)of the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome, measured as reduced levels of Troponin, BNP and reduced incidence of cardiac events, such as atrial fibrillation, need for inotropic drugs and myocardial infarction, compared with conventional propofol sedation.

Other end-points of the trial are potential renal (protective) effects measured with cystatin C levels, need for dialysis but also measurements of inorganic fluorides in serum, as well as environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit. Furthermore, potential differences in ICU memories and well-being during stay in the intensive Care Unit will be investigated via patient questionnaires.

Besides routine blood sampling, plasma will be saved for later analysis of inflammatory mediators (biobank).

Condition or disease Intervention/treatment Phase
Myocardial Reperfusion Injury Atrial Fibrillation Drug: Sevoflurane Drug: propofol Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting
Study Start Date : June 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: propofol
propofol for sedation minimum 2 hours in CTICU after CABG
Drug: propofol
propofol given intravenously for sedation in control group
Experimental: sevoflurane
Sevoflurane via AnaConDa for minimum 2 hours in CTICU after CABG
Drug: Sevoflurane
given by infusion via AnaConDa for sedation with target MAAS 2-3
Other Name: Sevorane

Primary Outcome Measures :
  1. Troponin levels [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. renal function [ Time Frame: 1 week ]
  2. ambient sevoflurane levels [ Time Frame: 2 days ]
  3. cognitive function/memory panorama post ICU [ Time Frame: 1 week ]
  4. attenuation of inflammatory response [ Time Frame: 2 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Planned coronary artery bypass grafting

Exclusion Criteria:

  • Combined heart valve surgery
  • Malignant Hyperthermia
  • Postoperative need for mechanical circulation support

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 identifier (NCT number): NCT00484575

Karolinska University Hospital Solna, Cardiothoracic Intensive Care Unit
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Peter V Sackey, MD, PhD Karolinska Institutet, Institution of Physiology and Pharmacology, Section for Anesthesia and Intensive Care Medicine
Principal Investigator: Jan-Olof Hellström, MD Karolinska Institutet, Institution of Physiology and Phrmacology, Section for Anesthesia and Intensive Care
Principal Investigator: Anders Öwall, MD, PhD Karolinska University Solna, Department of Cardiothoracic Anesthesia and Intensive Care

Responsible Party: Peter Sackey, MD, PhD, Dept of Physiology and Pharmacology, Karolinska Institutet Identifier: NCT00484575     History of Changes
Other Study ID Numbers: 2007-000293-23
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: May 20, 2010
Last Verified: June 2007

Keywords provided by Karolinska Institutet:

Additional relevant MeSH terms:
Atrial Fibrillation
Reperfusion Injury
Myocardial Reperfusion Injury
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Postoperative Complications
Myocardial Ischemia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation