Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000269639
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
2/09/2005
Date last updated
30/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of varying remifentanil infusion rates on target controlled infusion propofol concentrations necessary to maintain anaesthesia as assessed by bi-spectral index
Scientific title
The effect of varying remifentanil infusion rates on target controlled infusion propofol concentrations necessary to maintain anaesthesia as assessed by bi-spectral index
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 356 0
Condition category
Condition code
Anaesthesiology 417 417 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remifentanil and propofol at induction of anaesthesia.
Intervention code [1] 171 0
None
Comparator / control treatment
nil
Control group
Dose comparison

Outcomes
Primary outcome [1] 479 0
Dose of remifentanil and propofol required to maintain bi-spectral index < 50
Timepoint [1] 479 0
30 minutes
Secondary outcome [1] 1036 0
NIL
Timepoint [1] 1036 0
nil

Eligibility
Key inclusion criteria
Surgery under general anaesthesia.
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant and breastfeeding women, severe ischaemic heart disease, severe hypovolaemia, allergy to propofol or egg, emergency surgery, current opioid, benzodiazepine or high alcohol use.

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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
up-down sequential allocation with pool of 12 for each remifentanil infusion rate
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Up - down sequential allocation
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 355 0
6000

Funding & Sponsors
Funding source category [1] 471 0
Self funded/Unfunded
Name [1] 471 0
Country [1] 471 0
Primary sponsor type
Individual
Name
Dr Lars Wang
Address
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington St, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 378 0
Hospital
Name [1] 378 0
Royal Perth Hospital
Address [1] 378 0
Wellington St Perth WA 6000
Country [1] 378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1444 0
Royal Perth Hospital
Ethics committee address [1] 1444 0
Ethics committee country [1] 1444 0
Australia
Date submitted for ethics approval [1] 1444 0
Approval date [1] 1444 0
01/09/2004
Ethics approval number [1] 1444 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35612 0
Address 35612 0
Country 35612 0
Phone 35612 0
Fax 35612 0
Email 35612 0
Contact person for public queries
Name 9360 0
Lars Wang
Address 9360 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 9360 0
Australia
Phone 9360 0
+61 8 92241034
Fax 9360 0
Email 9360 0
lars.wang@health.wa.gov.au
Contact person for scientific queries
Name 288 0
Shauna Fatovich
Address 288 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 288 0
Australia
Phone 288 0
+61 8 92241036
Fax 288 0
Email 288 0
shauna.fatovich@health.wa.gov.au

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.