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Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400790
First Posted: November 17, 2006
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by:
University of Melbourne
  Purpose

Background: Different anaesthetic agents have been shown to have different protective effects upon heart, brain and renal function under ischaemic conditions (oxygen starvation). Cardiopulmonary bypass takes over the work of the heart and the lungs during heart surgery, but oxygenation of vital organs such as the brain and heart may not be perfect, and can produce brain or heart damage as a consequence. Propofol and desflurane are commonly used anaesthetic agents, and there has been recent research to suggest that anaesthetic agents may provide some protection during periods where inadequate oxygenation occurs, with the potential to reduce the degree of organ damage. Both types of anaesthetics are used for cardiac surgery with anaesthetists choosing between them largely on the basis of personal preference.

Aim: To determine whether the use of either propofol or desflurane as the primary anaesthetic agent, can lead to differences in postoperative brain function, total morbidity or cost, following coronary artery surgery with cardiopulmonary bypass.

Methods: Patients will be recruited by professional research staff and will be randomised into one of two groups (90 in each group). They will receive a standardized technique for anaesthesia, cardiopulmonary bypass and postoperative ICU treatment. The only difference between the 2 groups will be as to which anaesthetic agent they receive during the surgical period, desflurane or propofol. Measurements will involve i) brain function testing before and 3 months after surgery ( a set of 10 verbal or manual tests), ii) incidence of delirium in the immediate postoperative period (a survey form), iii) incidence of total postoperative morbidity and iv) cost of hospital stay. Data collection will be by anaesthesia and research staff and a neuropsychologist will employed for performing the brain function testing.

Anticipated timeline: Initial recruitment completed by 15-18 months following trial commencement. Follow up completed 3 month after the last enrolment. Data validation, statistical analysis and manuscript preparation completed by 24 months.


Condition Intervention
Coronary Artery Bypass Delirium Dementia Amnesia Cognition Disorders Morbidity Drug: propofol Drug: desflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Study of Organ Protection Comparing Desflurane and Propofol in Adult Patients Undergoing Coronary Artery Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Postoperative cognitive decline [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Delirium as defined using the Confusion Assessment Method [ Time Frame: 24 hours ]
  • Composite Morbidity [ Time Frame: in hospital (average time 6-7 days) ]
  • Cost of postoperative care [ Time Frame: in hospital ]

Enrollment: 182
Study Start Date: September 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: propofol
    Propofol used as the primary anaesthetic agent
    Drug: desflurane
    Desflurane used as the primary anaesthetic
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery bypass surgery

Exclusion Criteria:

  • Off-pump cardiac surgery
  • Require surgery for acute coronary syndrome
  • Dialysis dependent renal dysfunction
  • Severe liver dysfunction as determined by liver transaminases 1.5X greater than normal.
  • Pre-existing diagnosis of schizophrenia, dementia recent stroke or cognitive disorder
  • Recent alcohol/drug abuse/intoxication
  • Re-do Coronary Artery Grafts
  • Coronary Artery Grafts plus other surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400790


Locations
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
University of Melbourne
Baxter Healthcare Corporation
Investigators
Principal Investigator: Colin F Royse, MBBS, MD Melbourne Health and University of Melbourne
  More Information

Responsible Party: Colin Royse, University of Melbourne
ClinicalTrials.gov Identifier: NCT00400790     History of Changes
Other Study ID Numbers: 0608121
First Submitted: November 16, 2006
First Posted: November 17, 2006
Last Update Posted: June 29, 2010
Last Verified: January 2010

Keywords provided by University of Melbourne:
neurocognitive decline
coronary artery bypass surgery
composite morbidity
postoperative care cost

Additional relevant MeSH terms:
Dementia
Delirium
Cognition Disorders
Amnesia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Memory Disorders
Propofol
Desflurane
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation