Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Postoperative cognitive decline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Delirium as defined using the Confusion Assessment Method [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Composite Morbidity [ Time Frame: in hospital (average time 6-7 days) ] [ Designated as safety issue: No ]
- Cost of postoperative care [ Time Frame: in hospital ] [ Designated as safety issue: No ]
| 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) |
-
Drug: propofol
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Australia, Victoria | |
| Royal Melbourne Hospital | |
| Melbourne, Victoria, Australia, 3050 | |
| Principal Investigator: | Colin F Royse, MBBS, MD | Melbourne Health and University of Melbourne |
More Information
No publications provided
| Responsible Party: | Colin Royse, University of Melbourne |
| ClinicalTrials.gov Identifier: | NCT00400790 History of Changes |
| Other Study ID Numbers: | 0608121 |
| Study First Received: | November 16, 2006 |
| Last Updated: | June 28, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Amnesia Cognition Disorders Delirium Dementia Memory Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Confusion Brain Diseases |
Central Nervous System Diseases Propofol Desflurane Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on June 18, 2013