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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
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
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
Sex
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
NA
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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
182
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
Trial website
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

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