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Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting
This study is currently recruiting participants.
Verified by Karolinska Institutet, June 2007
Sponsored by: Karolinska Institutet
Information provided by: Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00484575
  Purpose

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 Intervention Phase
Myocardial Reperfusion Injury
Atrial Fibrillation
Drug: Sevoflurane
Phase I
Phase II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Anesthesia Coronary Artery Bypass Surgery
Drug Information available for: Sevoflurane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Troponin and BNP levels [ Time Frame: 2 days ]

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

Estimated Enrollment: 120
Study Start Date: June 2007
Estimated Study Completion Date: November 2007
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned coronary artery bypass grafting

Exclusion Criteria:

  • Combined heart valve surgery
  • Malignant Hyperthermia
  • Postoperative need for mechanical circulation support
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484575

Contacts
Contact: Jan-Olof Hellström, MD +46706687420 jan-olof.hellstrom@karolinska.se
Contact: Peter V Sackey, MD, PhD +46707710364 peter.sackey@karolinska.se

Locations
Sweden
Karolinska University Hospital Solna, Cardiothoracic Intensive Care Unit Recruiting
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
Investigators
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
  More Information

Study ID Numbers: 2007-000293-23
Study First Received: June 8, 2007
Last Updated: June 21, 2007
ClinicalTrials.gov Identifier: NCT00484575  
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
Sevoflurane
CABG
cardioprotection
AnaConDa

Study placed in the following topic categories:
Heart Diseases
Postoperative Complications
Myocardial Ischemia
Vascular Diseases
Ischemia
Atrial Fibrillation
Cardiomyopathies
Myocardial Reperfusion Injury
Sevoflurane
Arrhythmias, Cardiac
Reperfusion Injury

Additional relevant MeSH terms:
Anesthetics, Inhalation
Pathologic Processes
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009