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Trial registered on ANZCTR


Trial ID
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.
Scientific title
Observing the effect of muscle relaxants on the Bispectral Index depth-of-anaesthesia monitoring device (BIS) in awake healthy volunteers.
Secondary ID [1] 282557 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Detection of awareness during anaesthesia following administration of muscle relaxant drugs. 289198 0
Condition category
Condition code
Anaesthesiology 289527 289527 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287196 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 289625 0
Decrease in BIS number
Timepoint [1] 289625 0
BIS index numbers will be examined continuously until after the recovery of muscle function and the return of BIS to baseline values.
Secondary outcome [1] 302957 0
Nil
Timepoint [1] 302957 0
Nil

Eligibility
Key inclusion criteria
ASA 1 or 2
Previous uneventful anaesthesia
Minimum age
25 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Gastro-oesophageal reflux
BMI > 30

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
QLD
Recruitment hospital [1] 1040 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 6901 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 287316 0
Hospital
Name [1] 287316 0
Cairns Base Hospital
Address [1] 287316 0
Dept of Anaesthesia & Intensive care
P O Box 902
Cairns Qld 4870
Country [1] 287316 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Schuller
Address
Dept of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
Country
Australia
Secondary sponsor category [1] 286065 0
None
Name [1] 286065 0
Address [1] 286065 0
Country [1] 286065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289289 0
Cairns & Hinterland Human Research Ethics Committee
Ethics committee address [1] 289289 0
Professional House
88 Abbott Street
PO Box 902
Cairns Qld 4870
Ethics committee country [1] 289289 0
Australia
Date submitted for ethics approval [1] 289289 0
18/02/2013
Approval date [1] 289289 0
01/05/2013
Ethics approval number [1] 289289 0
HREC//13/QCH/20-829

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 40086 0
Dr Peter Schuller
Address 40086 0
Department of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
Country 40086 0
Australia
Phone 40086 0
+61 7 4226 9506
Fax 40086 0
Email 40086 0
peter.schuller@health.qld.gov.au
Contact person for public queries
Name 40087 0
Dr Peter Schuller
Address 40087 0
Department of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
Country 40087 0
Australia
Phone 40087 0
+61 7 4226 9506
Fax 40087 0
Email 40087 0
peter.schuller@health.qld.gov.au
Contact person for scientific queries
Name 40088 0
Dr Peter Schuller
Address 40088 0
Department of Anaesthesia & Intensive care
Cairns Base Hospital
P O Box 902
Cairns Qld 4870
Country 40088 0
Australia
Phone 40088 0
+61 7 4226 9506
Fax 40088 0
Email 40088 0
peter.schuller@health.qld.gov.au