NCT00569816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
Last Updated

December 7, 2007

Status Verified

November 1, 2007

First QC Date

December 6, 2007

Last Update Submit

December 6, 2007

Conditions

Myocardial Injury

Keywords

myocardial protectionpharmacological preconditioningvolatile anestheticsmyocardial injury following CABG surgery

Outcome Measures

Primary Outcomes (1)

  • Myocardial cell damage as assessed by plasma levels of Troponin T

    from induction of anesthesia until hospital discharge

Secondary Outcomes (1)

  • Length of stay on the ICU and in the hospital

    from hospital admission until hospital discharge

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Propofol as the primary anesthetic

Drug: Sevoflurane

Group 2

EXPERIMENTAL

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

Drug: Sevoflurane

Group 3

EXPERIMENTAL

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

Interventions

SevofluraneDRUG

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 1Group 2Group 3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients schedulded to undergo CABG surgery
  • Age 18 to 80 years
  • Ejection fraction \> 40%

You may not qualify if:

  • Emergency cases
  • Diabetes
  • Not able to give informed consent
  • Ejection fraction \< 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Jens Scholz, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

January 1, 2005

Study Completion

May 1, 2007

Last Updated

December 7, 2007

Record last verified: 2007-11

Locations

DE(1)