Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000144910
Ethics application status
Approved
Date submitted
7/02/2011
Date registered
8/02/2011
Date last updated
14/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quantifying the effect of the sedative alprazolam on brain electrical activity using the Brain Anaesthesia Response monitor
Scientific title
Quantifying the effect of alprazolam on brain electrical activity in healthy males using the BAR monitor
Secondary ID [1] 253560 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetic depth using processed electroencephalography 261120 0
Condition category
Condition code
Anaesthesiology 259268 259268 0 0
Anaesthetics
Neurological 259273 259273 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single 1 mg oral alprazolam dose
Intervention code [1] 257992 0
Treatment: Drugs
Comparator / control treatment
resting EEG prior to drug treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262086 0
Change in BAR index (mean pole location)
Timepoint [1] 262086 0
BAR index recorded for 5 minutes every hour for 3 hours following drug administration
Secondary outcome [1] 273127 0
Changes from baseline in relative delta, theta, alpha, beta and gamma power will be assessed using repeated measures ANOVA.
Timepoint [1] 273127 0
Assessed every hour for 3 hours following drug administration

Eligibility
Key inclusion criteria
non-smoker, no history of anxiety, depression or other psychiatric disorder, no history of epilepsy or other neurological disorder known to affect resting EEG
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
consumption of any pharmaceutical product/medicine in last 30 days, consumption of vitamin complex or herbal extract withion last 30 days, history of alcohol or drug abuse

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258449 0
Commercial sector/Industry
Name [1] 258449 0
Cortical Dynamics Ltd
Country [1] 258449 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
P.O. Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 257594 0
None
Name [1] 257594 0
Address [1] 257594 0
Country [1] 257594 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study is designed to evaluate a new method for monitoring the effects of sedatives on the brain's electrical activity. The method involves a sophisticated, physiologically motivated, algorithm for the analysis of the scalp recorded electroencephalogram.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32183 0
Address 32183 0
Country 32183 0
Phone 32183 0
Fax 32183 0
Email 32183 0
Contact person for public queries
Name 15430 0
Associate Professor David TJ Liley
Address 15430 0
Brain and Psychological Sciences Research Centre
Swinburne University of Technology
P.O. Box 218
Hawthorn VIC 3122
Country 15430 0
Australia
Phone 15430 0
+61 3 9214 8812
Fax 15430 0
Email 15430 0
[email protected]
Contact person for scientific queries
Name 6358 0
Associate Professor David TJ Liley
Address 6358 0
Brain and Psychological Sciences Research Centre
Swinburne University of Technology
P.O. Box 218
Hawthorn VIC 3122
Country 6358 0
Australia
Phone 6358 0
+61 3 9124 8812
Fax 6358 0
Email 6358 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.