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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
A Randomised Controlled Study of Organ Protection Comparing Desflurane and Propofol in Adult Patients Undergoing Coronary Artery Surgery With Cardiopulmonary Bypass
Secondary ID [1] 0 0
0608121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Bypass 0 0
Delirium 0 0
Dementia 0 0
Amnesia 0 0
Cognition Disorders 0 0
Morbidity 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Psychosis and personality disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Postoperative cognitive decline
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Delirium as defined using the Confusion Assessment Method
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Composite Morbidity
Timepoint [2] 0 0
in hospital (average time 6-7 days)
Secondary outcome [3] 0 0
Cost of postoperative care
Timepoint [3] 0 0
in hospital

Eligibility
Key inclusion criteria
- Coronary artery bypass surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Baxter Healthcare Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00400790
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colin F Royse, MBBS, MD
Address 0 0
Melbourne Health and University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications