Trial registered on ANZCTR


Trial ID
ACTRN12605000285651
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
5/09/2005
Date last updated
18/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The AustraliaN Trial Investigating Post Operative Deficit, Early extubation and Survival (ANTIPODES)
Scientific title
The prospective randomised controlled ANTIPODES Trial will test whether early extubation following coronary artery graft surgery (CAGS) and the perioperative anaesthetic management that permits early extubation, results in a significant reduction in postoperative cognitive dysfunction in the short and medium term.
Secondary ID [1] 260030 0
nil
Universal Trial Number (UTN)
Trial acronym
The ANTIPODES Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Operative Cognitive Dysfunction (POCD) 373 0
Condition category
Condition code
Surgery 440 440 0 0
Other surgery
Anaesthesiology 441 441 0 0
Anaesthetics
Mental Health 442 442 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To test whether early extubation following CAGS results in a significant reduction in the incidence of POCD. Low dose anaesthesia permitting early extubation will consist of routine clinical practice using fentanyl 10 micrograms/kg, propofol as required. High dose fentanyl anaesthesia will consist of routine clinical practice using fentanyl 50 micrograms/kg, propofol as required. Patients will complete a battery of neuropsychological tests preoperatively, and 6 days, 3 months and 12 months postoperatively. Quality of life and depression will be assessed preoperatively and at 3 months and 12 months postoperatively.
Intervention code [1] 159 0
Treatment: Other
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 500 0
Frequency of POCD
Timepoint [1] 500 0
Secondary outcome [1] 1081 0
Length of time in ICU
Timepoint [1] 1081 0
Secondary outcome [2] 1082 0
Length of stay in hospital
Timepoint [2] 1082 0
Secondary outcome [3] 1083 0
Cumulative incidence of death and complications.
Timepoint [3] 1083 0

Eligibility
Key inclusion criteria
Scheduled for first time coronary artery bypass surgery, who give written informed consent. Patients must be suitable for neuropsychological testing and without neurological deficit.
Minimum age
55 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Poor left ventricular function (ejection fraction < 30%); 2. major systemic illness contraindicating early extubation (eg. chronic respiratory impairment); 3. pre-existing neurological disease (eg. stroke); 4. anticipated difficulty with neuropsychological assessment such as English not being the prime language.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope allocated to each patient and distributed to anaesthetist immediately prior to surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated from a table of random numbers. The restriction method will be random permuted blocks. Sequence will be stratified for hospital (site) and off-pump/om-pump.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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)

Funding & Sponsors
Funding source category [1] 493 0
Government body
Name [1] 493 0
National Health and Medical Research Council
Address [1] 493 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 493 0
Australia
Funding source category [2] 264915 0
Other Collaborative groups
Name [2] 264915 0
Australian and New Zealand College of Anaesthetists (ANZCA)
Address [2] 264915 0
St Kilda Road, Melbourne
Country [2] 264915 0
Australia
Primary sponsor type
Individual
Name
Dr. Brendan Silbert
Address
Country
Secondary sponsor category [1] 395 0
Individual
Name [1] 395 0
A/Prof. David Scott
Address [1] 395 0
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900, Fitzroy 3065
Country [1] 395 0
Australia
Secondary sponsor category [2] 396 0
Individual
Name [2] 396 0
A/Prof. Paul Maruff
Address [2] 396 0
Neurosciences Department, University of Melbourne, Parkville, Victoria
Country [2] 396 0
Australia
Secondary sponsor category [3] 397 0
Individual
Name [3] 397 0
A/Prof Paul Myles
Address [3] 397 0
Department of Anaesthesia and Pain Management, Alfred Hospital, Commercial Road, Prahran
Country [3] 397 0
Australia
Secondary sponsor category [4] 398 0
Individual
Name [4] 398 0
A/Prof Konrad Jamrozik
Address [4] 398 0
c/o St. Vincent's Hospital, PO Box 2900, Fitzroy 3065
Country [4] 398 0
Australia
Secondary sponsor category [5] 399 0
Individual
Name [5] 399 0
Ms. Lis Evered
Address [5] 399 0
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900, Fitzroy 3065
Country [5] 399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1468 0
St. Vincent's Hospital Melbourne
Ethics committee address [1] 1468 0
PO Box 2900
Fitzroy 3065
Ethics committee country [1] 1468 0
Australia
Date submitted for ethics approval [1] 1468 0
Approval date [1] 1468 0
01/01/2001
Ethics approval number [1] 1468 0
004/01
Ethics committee name [2] 1469 0
St. Vincent's Private Hospital
Ethics committee address [2] 1469 0
Melbourne
Ethics committee country [2] 1469 0
Australia
Date submitted for ethics approval [2] 1469 0
Approval date [2] 1469 0
01/06/2001
Ethics approval number [2] 1469 0
Ethics committee name [3] 1470 0
Alfred Hospital
Ethics committee address [3] 1470 0
Melbourne
Ethics committee country [3] 1470 0
Australia
Date submitted for ethics approval [3] 1470 0
Approval date [3] 1470 0
Ethics approval number [3] 1470 0

Summary
Brief summary
Trial website
www.cognition.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35724 0
Address 35724 0
Country 35724 0
Phone 35724 0
Fax 35724 0
Email 35724 0
Contact person for public queries
Name 9348 0
Dr. Brendan Silbert
Address 9348 0
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 9348 0
Australia
Phone 9348 0
+61 3 92884253
Fax 9348 0
+61 3 92884255
Email 9348 0
brendan.silbert@svhm.org.au
Contact person for scientific queries
Name 276 0
Ms. Lis Evered
Address 276 0
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 276 0
Australia
Phone 276 0
+61 3 92882251
Fax 276 0
+61 3 92884255
Email 276 0
lis.evered@svhm.org.au