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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ 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
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

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
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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
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

No publications provided

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
Study First Received: December 6, 2007
Last Updated: December 6, 2007
Health Authority: Germany: Ethics Commission

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014