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Organ Protection for CABG: Propofol Versus Desflurane
This study is currently recruiting participants.
Verified by University of Melbourne, September 2007
Sponsors and Collaborators: University of Melbourne
Baxter Healthcare Corporation
Information provided by: University of Melbourne
ClinicalTrials.gov Identifier: NCT00400790
  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, Amnestic, Cognitive Disorders
Morbidity
Drug: propofol anaesthetic
Drug: desflurane anaesthetic

MedlinePlus related topics: Anesthesia Coronary Artery Bypass Surgery Dementia
Drug Information available for: Propofol I 653
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomised Controlled Study of Organ Protection Comparing Desflurane and Propofol in Adult Patients Undergoing Coronary Artery Surgery With Cardiopulmonary Bypass

Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Postoperative cognitive decline

Secondary Outcome Measures:
  • Delirium
  • Composite Morbidity
  • Cost of postoperative care

Estimated Enrollment: 180
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400790

Contacts
Contact: Colin F Royse, MBBS, MD +61383445673 colin.royse@unimelb.edu.au
Contact: Alistair G Royse, MBBS, MD +61383445673 alistair.royse@mh.org.au

Locations
Australia, Victoria
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Colin F Royse, MBBS,MD     +61383445673     colin.royse@unimelb.edu.au    
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

Study ID Numbers: 0608121
Study First Received: November 16, 2006
Last Updated: September 27, 2007
ClinicalTrials.gov Identifier: NCT00400790  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Study placed in the following topic categories:
Desflurane
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Propofol
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Anesthetics, Intravenous
Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009