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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
Est. primary completion date
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


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
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