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Trial registered on ANZCTR
Registration number
ACTRN12613000587707
Ethics application status
Approved
Date submitted
22/05/2013
Date registered
24/05/2013
Date last updated
8/06/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
B-AWAKE - The effect of muscle relaxants on the performance of the Bispectral Index depth-of-anaesthesia monitoring device.
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Scientific title
Observing the effect of muscle relaxants on the Bispectral Index depth-of-anaesthesia monitoring device (BIS) in awake healthy volunteers.
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Secondary ID [1]
282557
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Detection of awareness during anaesthesia following administration of muscle relaxant drugs.
289198
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Condition category
Condition code
Anaesthesiology
289527
289527
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The response of the Bispectral Index device (BIS) will be observed following the administration of suxamethonium 1.5 mg/kg i.v., until the drug effect ceases. On a separate occasion, at least 2 weeks later, the same subject will repeat the experiment but with rocuronium 0.7mg/kg i.v., to be reversed with sugammadex 200mg i.v.
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Intervention code [1]
287196
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Treatment: Drugs
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Comparator / control treatment
The comparator is no drug administration. The BIS system is accepted to reliably report a number in the "awake" range in the unsedated patient. This will be confirmed with each individual participant, for a period of 5 minutes prior to administration of the study drug.
Due to the effect of suxamethonium, it is immediately apparent to both the subject and the investigators that the drug has been administered. This renders it impossible to compare to placebo in a blinded fashion.
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Control group
Active
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Outcomes
Primary outcome [1]
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Decrease in BIS number
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Assessment method [1]
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Timepoint [1]
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BIS index numbers will be examined continuously until after the recovery of muscle function and the return of BIS to baseline values.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
ASA 1 or 2
Previous uneventful anaesthesia
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Minimum age
25
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Gastro-oesophageal reflux
BMI > 30
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
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Type of endpoint/s
Pharmacodynamics
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/08/2013
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Actual
26/09/2013
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Date of last participant enrolment
Anticipated
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Actual
8/11/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
1040
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Cairns Base Hospital - Cairns
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Recruitment postcode(s) [1]
6901
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4870 - Cairns
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Cairns Base Hospital
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Address [1]
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Dept of Anaesthesia & Intensive care
P O Box 902
Cairns Qld 4870
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Country [1]
287316
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Australia
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Primary sponsor type
Individual
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Name
Dr Peter Schuller
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Address
Dept of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
286065
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Address [1]
286065
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Country [1]
286065
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Cairns & Hinterland Human Research Ethics Committee
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Ethics committee address [1]
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Professional House
88 Abbott Street
PO Box 902
Cairns Qld 4870
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Ethics committee country [1]
289289
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Australia
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Date submitted for ethics approval [1]
289289
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18/02/2013
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Approval date [1]
289289
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01/05/2013
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Ethics approval number [1]
289289
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HREC//13/QCH/20-829
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Summary
Brief summary
The Bispectral Index system (BIS) is an electronic device used during anaesthesia to determine whether or not a patient is "awake". A previous study reported that when fully awake subjects were given the muscle relaxant suxamethonium, the BIS system incorrectly reported that they were anaesthetised.
Our study will investigate the effect of the two muscle relaxant drugs suxamethonium, and rocuronium, in awake volunteers, to confirm whether or not the BIS system behaves in this manner.
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Trial website
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Trial related presentations / publications
Schuller PJ, Newell S, Strickland PA, Barry JJ (2015) Response of bispectral index to neuromuscular block in awake volunteers. Br J Anaesth. 2015 Jul;115 Suppl 1:i95-i103. doi: 10.1093/bja/aev072.
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Public notes
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Contacts
Principal investigator
Name
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Dr Peter Schuller
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Address
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Department of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
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Country
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Australia
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Phone
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+61 7 4226 9506
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Peter Schuller
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Address
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Department of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
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Country
40087
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Australia
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Phone
40087
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+61 7 4226 9506
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Fax
40087
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Email
40087
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[email protected]
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Contact person for scientific queries
Name
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Dr Peter Schuller
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Address
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Department of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
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Country
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Australia
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Phone
40088
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+61 7 4226 9506
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Fax
40088
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Response of bispectral index to neuromuscular block in awake volunteers.
2015
https://dx.doi.org/10.1093/bja/aev072
N.B. These documents automatically identified may not have been verified by the study sponsor.
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