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Continuous Versus Repetitive Sevoflurane Administration for Preconditioning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569816
First Posted: December 7, 2007
Last Update Posted: December 7, 2007
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.
Collaborators:
Department of Anaesthesiology and Intensive Care Medicine
Abbott
Information provided by:
University of Schleswig-Holstein
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison Between Continuous and Repetitive Sevoflurane Administration for Preconditioning During Coronary Artery Bypass Surgery

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Length of stay on the ICU and in the hospital [ Time Frame: from hospital admission until hospital discharge ]

Enrollment: 50
Study Start Date: January 2005
Study Completion Date: May 2007
Arms Assigned Interventions
Active Comparator: Group 1
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.
Experimental: Group 2
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.
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.
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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00569816


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

Responsible Party: Prof. Dr. Jens Scholz, University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00569816     History of Changes
Other Study ID Numbers: UKSHCK-Anae07/06
ACA-GmbH-03-7
First Submitted: December 6, 2007
First Posted: December 7, 2007
Last Update Posted: December 7, 2007
Last Verified: November 2007

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

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs