Continuous Versus Repetitive Sevoflurane Administration for Preconditioning

Myocardial Injury Clinical Trial

Official title:

A Comparison Between Continuous and Repetitive Sevoflurane Administration for Preconditioning During Coronary Artery Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569816
• Other study ID #: UKSHCK-Anae07/06
• Secondary ID: ACA-GmbH-03-7
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2007
• Last updated: December 6, 2007
• Start date: January 2005
• Est. completion date: May 2007

Study information

• Verified date: November 2007
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Injury

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel

Sponsors (3)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Abbott, Department of Anaesthesiology and Intensive Care Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial cell damage as assessed by plasma levels of Troponin T		from induction of anesthesia until hospital discharge	No
Secondary	Length of stay on the ICU and in the hospital		from hospital admission until hospital discharge	No