Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane
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|ClinicalTrials.gov Identifier: NCT00400790|
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : June 29, 2010
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
- Drug: propofol
Propofol used as the primary anaesthetic agent
- Drug: desflurane
Desflurane used as the primary anaesthetic
- Postoperative cognitive decline [ Time Frame: 3 months ]
- 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 ]
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
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Principal Investigator:||Colin F Royse, MBBS, MD||Melbourne Health and University of Melbourne|