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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00400790
Registration number
NCT00400790
Ethics application status
Date submitted
16/11/2006
Date registered
17/11/2006
Date last updated
29/06/2010
Titles & IDs
Public title
Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane
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Scientific title
A Randomised Controlled Study of Organ Protection Comparing Desflurane and Propofol in Adult Patients Undergoing Coronary Artery Surgery With Cardiopulmonary Bypass
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Secondary ID [1]
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0608121
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Bypass
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Delirium
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Dementia
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Amnesia
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Cognition Disorders
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Morbidity
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Mental Health
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Learning disabilities
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Neurological
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0
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - propofol
Treatment: Drugs - desflurane
Treatment: Drugs: propofol
Propofol used as the primary anaesthetic agent
Treatment: Drugs: desflurane
Desflurane used as the primary anaesthetic
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Postoperative cognitive decline
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Assessment method [1]
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Delirium as defined using the Confusion Assessment Method
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Assessment method [1]
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Timepoint [1]
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24 hours
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Secondary outcome [2]
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Composite Morbidity
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Assessment method [2]
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Timepoint [2]
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in hospital (average time 6-7 days)
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Secondary outcome [3]
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Cost of postoperative care
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Assessment method [3]
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Timepoint [3]
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in hospital
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Eligibility
Key inclusion criteria
* Coronary artery bypass surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2010
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Sample size
Target
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Accrual to date
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Final
182
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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3050 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Baxter Healthcare Corporation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00400790
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Colin F Royse, MBBS, MD
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Address
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Melbourne Health and University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00400790
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