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Continuous Versus Repetitive Sevoflurane Administration for Preconditioning
This study has been completed.
First Received: December 6, 2007   No Changes Posted
Sponsors and Collaborators: University of Schleswig-Holstein
Abbott
Information provided by: University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00569816
  Purpose

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.


Condition Intervention Phase
Myocardial Injury
Drug: Sevoflurane
Phase IV

MedlinePlus related topics: Anesthesia Surgery
Drug Information available for: Sevoflurane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title: A Comparison Between Continuous and Repetitive Sevoflurane Administration for Preconditioning During Coronary Artery Bypass Surgery

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Length of stay on the ICU and in the hospital [ Time Frame: from hospital admission until hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2005
Study Completion Date: May 2007
Arms Assigned Interventions
Group 1: Active Comparator
Propofol as the primary anesthetic
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.
Group 2: Experimental
Sevoflurane administered continuously after induction of anesthesia until initiation of cardiopulmonary bypass.
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.
Group 3: Experimental
Sevoflurane administered repetitive up to 1 MAC from induction of anesthesia until initiation of cardiopulmonary bypass. Wash in and wash out performed twice.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569816

Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Abbott
Investigators
Principal Investigator: Jens Scholz, MD University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine
  More Information

No publications provided

Responsible Party: University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine ( Prof. Dr. Jens Scholz )
Study ID Numbers: UKSHCK-Anae07/06, ACA-GmbH-03-7
Study First Received: December 6, 2007
Last Updated: December 6, 2007
ClinicalTrials.gov Identifier: NCT00569816     History of Changes
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
myocardial protection
pharmacological preconditioning
volatile anesthetics
myocardial injury following CABG surgery

Study placed in the following topic categories:
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Sevoflurane

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

ClinicalTrials.gov processed this record on May 06, 2009