Continuous Versus Repetitive Sevoflurane Administration for Preconditioning

This study has been completed.
Sponsor:
Collaborators:
Department of Anaesthesiology and Intensive Care Medicine
Abbott
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00569816
First received: December 6, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

December 6, 2007
December 6, 2007
January 2005
Not Provided
Myocardial cell damage as assessed by plasma levels of Troponin T [ Time Frame: from induction of anesthesia until hospital discharge ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Length of stay on the ICU and in the hospital [ Time Frame: from hospital admission until hospital discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Versus Repetitive Sevoflurane Administration for Preconditioning
A Comparison Between Continuous and Repetitive Sevoflurane Administration for Preconditioning During Coronary Artery Bypass Surgery

Pharmacologic preconditioning by volatile anesthetics may depend on the mode of administration. The researchers hypothesize that a continuous administration in patients scheduled for CABG surgery prebypass will be less effective in terms of attenuating myocardial cell damage compared to a repetitive administration with a double wash in/wash out schedule. A control group will receive propofol as their primary anesthetic.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myocardial Injury
Drug: Sevoflurane
1 MAC Sevoflurane will be given either continuously after induction of anesthesia until initiation of cardiopulmonary bypass or will be repetitively washed in and out twice before initiation of cardiopulmonary bypass.
  • Active Comparator: Group 1
    Propofol as the primary anesthetic
    Intervention: Drug: Sevoflurane
  • Experimental: Group 2
    Sevoflurane administered continuously after induction of anesthesia until initiation of cardiopulmonary bypass.
    Intervention: Drug: Sevoflurane
  • Experimental: Group 3
    Sevoflurane administered repetitive up to 1 MAC from induction of anesthesia until initiation of cardiopulmonary bypass. Wash in and wash out performed twice.
    Intervention: Drug: Sevoflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2007
Not Provided

Inclusion Criteria:

  • Patients schedulded to undergo CABG surgery
  • Age 18 to 80 years
  • Ejection fraction > 40%

Exclusion Criteria:

  • Emergency cases
  • Diabetes
  • Not able to give informed consent
  • Ejection fraction < 40%
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00569816
UKSHCK-Anae07/06, ACA-GmbH-03-7
No
Prof. Dr. Jens Scholz, University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine
University of Schleswig-Holstein
  • Department of Anaesthesiology and Intensive Care Medicine
  • Abbott
Principal Investigator: Jens Scholz, MD University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine
University of Schleswig-Holstein
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP