Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000888864
Ethics application status
Approved
Date submitted
20/08/2012
Date registered
21/08/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of inhaled xenon and nitrous oxide on brain activity recorded using magnetoencephalography (MEG) and electroencephalography (EEG)
Scientific title
A repeated measures cross-over design trial to compare the subanaesthetic actions of xenon and nitrous anaesthesia in healthy male participants using magnetoencephalography (MEG) and electroencephalography (EEG)
Secondary ID [1] 281043 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedation 287177 0
loss of consciousness 287178 0
Condition category
Condition code
Anaesthesiology 287509 287509 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be administered nitrous oxide and xenon in separate experimental sessions. Each experimental session will be separated by a period of 1 week to allow for washout of respective gas effects. Participants will be randomized to initially receive step-wise inhaled concentrations of either nitrous oxide or xenon. Nitrous oxide will be administered as a sequence of 3 inspired concentrations of 16%, 32% and 47% each lasting for 15 minutes and each separated by a period of 5 minutes of 100% oxygen. Xenon will be administered as a sequence of 3 inspired concentrations of 8%, 16% and 24% each lasting for 15 minutes and each separated by a period of 5 minutes of 100% oxygen followed by Xenon administered at an inspired concentration of 42% until loss of response to a vocal command.
Intervention code [1] 285504 0
Diagnosis / Prognosis
Comparator / control treatment
All recordings during nitrous oxide and xenon administration will be compared with 5 minute recordings obtained while participants freely breath room air prior to the commencement of each of the respective gas administrations. Both xenon and nitrous oxide treament groups will have equal weight in this trial.
Control group
Active

Outcomes
Primary outcome [1] 287760 0
Recorded high density electroencephalographic activity
Timepoint [1] 287760 0
At baseline, during all administered levels of xenon and nitrous oxide and at loss of response during xenon administration
Primary outcome [2] 287761 0
Recorded magnetoencephalographic activity
Timepoint [2] 287761 0
At baseline, during all administered levels of xenon and nitrous oxide and at loss of response during xenon administration
Secondary outcome [1] 298787 0
% correct response and latency of response to continuous auditory performance task
Timepoint [1] 298787 0
At baseline, during all administered levels of xenon and nitrous oxide

Eligibility
Key inclusion criteria
Healthy males aged 18 - 40 years
Non-smoker
Right handed
Able to read, write and speak English
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
A history of epilepsy or other neurological condition
A history of depression, anxiety or other psychiatric illness
Asthma or other respiratory illness
Obstructive sleep apnoea or severe snoring
A history of alcohol or drug abuse
Taken any pharmaceutical product/medicine in the last 30 days prior to first gas administration session

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)
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
1/09/2012
Actual
19/10/2015
Date of last participant enrolment
Anticipated
Actual
21/11/2017
Date of last data collection
Anticipated
Actual
28/11/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285828 0
University
Name [1] 285828 0
Swinburne University of Technology
Country [1] 285828 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 284652 0
None
Name [1] 284652 0
Nil
Address [1] 284652 0
Nil
Country [1] 284652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287867 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 287867 0
Ethics committee country [1] 287867 0
Australia
Date submitted for ethics approval [1] 287867 0
Approval date [1] 287867 0
20/08/2012
Ethics approval number [1] 287867 0

Summary
Brief summary
Despite many decades of effective and safe use the mechanisms by which anaesthetics induce unconsciousness remain unresolved. While our knowledge of the molecular and cellular targets of anaesthetic action has increased substantially in the last couple of decades our knowledge regarding their effects on measured brain activity has progressed at a slower rate. The aim of this study is, for the first time, to use a high resolution method of brain imaging to better quantify the effects anaesthetic agents have on brain activity. Specifically we will quantify the effects of two volatile anaesthetic agents, nitrous oxide and xenon, on brain activity recorded using a high resolution brain imaging technique known as magnetoencephalography. These agents are chosen because of their reported differing effects on brain activity, their reported similar molecular targets of action and the fact that they are safe to administer in a research imaging environment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34585 0
Prof David Liley
Address 34585 0
Centre for Human Pyschopharmacology,
Swinburne University of Technology
Hawthorn VIC 3122
Country 34585 0
Australia
Phone 34585 0
+61392148812
Fax 34585 0
Email 34585 0
[email protected]
Contact person for public queries
Name 17832 0
Prof Professor David Liley
Address 17832 0
Brain and Psychological Sciences Research Centre
Swinburne University of Technology
Hawthorn VIC 3122
Country 17832 0
Australia
Phone 17832 0
+61-3-9214 8812
Fax 17832 0
Email 17832 0
[email protected]
Contact person for scientific queries
Name 8760 0
Prof Professor David Liley
Address 8760 0
Brain and Psychological Sciences Research Centre
Swinburne University of Technology
Hawthorn VIC 3122
Country 8760 0
Australia
Phone 8760 0
+61-3-9214 8812
Fax 8760 0
Email 8760 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
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