Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000763640
Ethics application status
Approved
Date submitted
18/11/2005
Date registered
24/11/2005
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of remifentanil on electroencephalographic BAR index during propofol anaesthesia
Scientific title
A randomised study to evaluate the effects of remifentanil on the monitoring of anaesthetic depth with the BAR index or BIS during propofol anaesthesia
Secondary ID [1] 287992 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetic depth and EEG changes 919 0
Condition category
Condition code
Anaesthesiology 986 986 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remifentanil effect-site target 2 or 4 ng/ml during induction of anaesthesia with propofol
Intervention code [1] 766 0
None
Comparator / control treatment
Remifentanil effect-site target 0 (control) ng/ml during induction of anaesthesia with propofol
Control group
Placebo

Outcomes
Primary outcome [1] 1309 0
Depth of anaesthesia (loss of eyelash reflex, response to command or painful stimulation) during induction of anaesthesia
Timepoint [1] 1309 0
Assessed every 5 minutes during slow induction of anaesthesia with propofol until loss of response to painful stimulation
Secondary outcome [1] 2347 0
Propofol concentrations and EEG measures preventing 50% of patients from responding during induction of anaesthesia.
Timepoint [1] 2347 0
Assessed every 5 minutes during slow induction of anaesthesia with propofol until loss of response to painful stimulation

Eligibility
Key inclusion criteria
ASA physical status 1-3 presenting for elective surgery under GA.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with EEG abnormalities will not be included.

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2006
Actual
12/09/2006
Date of last participant enrolment
Anticipated
Actual
10/09/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1083 0
Commercial sector/Industry
Name [1] 1083 0
Biopharmica Limited
Country [1] 1083 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Royal Melbourne Hospital, Parkville, Victoria, 3050
Country
Australia
Secondary sponsor category [1] 944 0
Commercial sector/Industry
Name [1] 944 0
Biopharmica Limited
Address [1] 944 0
1 Dalmore Drive, Scoresby, VIC, 3179
Country [1] 944 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293915 0
Melbourne Health HREC
Ethics committee address [1] 293915 0
Royal Melbourne Hospital
Parkville VIC 3050
Ethics committee country [1] 293915 0
Australia
Date submitted for ethics approval [1] 293915 0
22/07/2008
Approval date [1] 293915 0
07/08/2008
Ethics approval number [1] 293915 0
Nil known

Summary
Brief summary
These data were not published because the quality of the EEG data was very poor. This was due to equipment malfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35571 0
Prof Kate Leslie
Address 35571 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia
Country 35571 0
Australia
Phone 35571 0
+61-3-93427540
Fax 35571 0
Email 35571 0
[email protected]
Contact person for public queries
Name 9955 0
Associate Professor Kate Leslie
Address 9955 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 9955 0
Australia
Phone 9955 0
+61 3 93427000
Fax 9955 0
Email 9955 0
[email protected]
Contact person for scientific queries
Name 883 0
Associate Professor Kate Leslie
Address 883 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 883 0
Australia
Phone 883 0
+61 3 93427000
Fax 883 0
Email 883 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.