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Continuous Versus Repetitive Sevoflurane Administration for Preconditioning

NCT ID: NCT00569816

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Injury

Keywords

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myocardial protection pharmacological preconditioning volatile anesthetics myocardial injury following CABG surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

Propofol as the primary anesthetic

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

Sevoflurane administered continuously after induction of anesthesia until initiation of cardiopulmonary bypass.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

Sevoflurane administered repetitive up to 1 MAC from induction of anesthesia until initiation of cardiopulmonary bypass. Wash in and wash out performed twice.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Department of Anaesthesiology and Intensive Care Medicine

AMBIG

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role collaborator

Responsible Party

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University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine

Principal Investigators

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Jens Scholz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine

Locations

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University Hospital Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ACA-GmbH-03-7

Identifier Type: -

Identifier Source: secondary_id

UKSHCK-Anae07/06

Identifier Type: -

Identifier Source: org_study_id