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

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. Identifier: NCT00400790
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : June 29, 2010
Baxter Healthcare Corporation
Information provided by:
University of Melbourne

Brief Summary:

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 or disease Intervention/treatment Phase
Coronary Artery Bypass Delirium Dementia Amnesia Cognition Disorders Morbidity Drug: propofol Drug: desflurane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: propofol
    Propofol used as the primary anaesthetic agent
  • Drug: desflurane
    Desflurane used as the primary anaesthetic

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00400790

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Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
University of Melbourne
Baxter Healthcare Corporation
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Principal Investigator: Colin F Royse, MBBS, MD Melbourne Health and University of Melbourne
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Responsible Party: Colin Royse, University of Melbourne Identifier: NCT00400790    
Other Study ID Numbers: 0608121
First Posted: November 17, 2006    Key Record Dates
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:
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Cognition Disorders
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Memory Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation