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Sponsors and Collaborators: |
University of Melbourne Baxter Healthcare Corporation |
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Information provided by: | University of Melbourne |
ClinicalTrials.gov Identifier: | NCT00400790 |
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 |
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Coronary Artery Bypass Delirium, Dementia, Amnestic, Cognitive Disorders Morbidity |
Drug: propofol anaesthetic Drug: desflurane anaesthetic |
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 |
Estimated Enrollment: | 180 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Colin F Royse, MBBS, MD | +61383445673 | colin.royse@unimelb.edu.au |
Contact: Alistair G Royse, MBBS, MD | +61383445673 | alistair.royse@mh.org.au |
Australia, Victoria | |
Royal Melbourne Hospital | Recruiting |
Melbourne, Victoria, Australia, 3050 | |
Contact: Colin F Royse, MBBS,MD +61383445673 colin.royse@unimelb.edu.au |
Principal Investigator: | Colin F Royse, MBBS, MD | Melbourne Health and University of Melbourne |
Study ID Numbers: | 0608121 |
Study First Received: | November 16, 2006 |
Last Updated: | September 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00400790 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
neurocognitive decline coronary artery bypass surgery composite morbidity postoperative care cost |
Anesthetics, Intravenous Anesthetics Central Nervous System Depressants Cognition Disorders Desflurane Anesthetics, Inhalation Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Anesthetics, General Hypnotics and Sedatives Dementia Propofol Delirium |
Anesthetics, Intravenous Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cognition Disorders Pharmacologic Actions Anesthetics, Inhalation Desflurane |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Propofol Central Nervous System Agents |