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Trial registered on ANZCTR


Registration number
ACTRN12605000309684
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
6/09/2005
Date last updated
26/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quantifying the effect of nitrous oxide on the depth of anaesthesia using theoretically based time series modelling
Scientific title
The effect of nitrous oxide on a new measure of anaesthetic depth during sevoflurane anaesthesia
Secondary ID [1] 288011 0
Nil known
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetic depth and EEG changes 397 0
Condition category
Condition code
Anaesthesiology 469 469 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient randomised to 0% (control), 33% or 66% nitrous oxide during induction of anaethesia with sevoflurane.
Intervention code [1] 306 0
Other interventions
Comparator / control treatment
0% (control) nitrous oxide during induction of anaethesia with sevoflurane.
Control group
Dose comparison

Outcomes
Primary outcome [1] 531 0
The effect of nitrous oxide on the EEG during induction of anaesthesia with sevoflurane
Timepoint [1] 531 0
The EEG is recorded continuously from the commencement of sevoflurane administration until loss of response to painful stimulation.
Secondary outcome [1] 1137 0
None
Timepoint [1] 1137 0
No secondary outcome - no timepoint for secondary outcome.

Eligibility
Key inclusion criteria
Presenting for surgery, not at risk of gastrointestinal reflux during anaeshtesia, and without epilepsy or other EEG adnormalities.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Concealment in opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using computer generated random number list. No blocking or stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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)
VIC

Funding & Sponsors
Funding source category [1] 527 0
Other Collaborative groups
Name [1] 527 0
ANZCA
Address [1] 527 0
630 St Kilda Rd, Melbourne, VIC, 3004
Country [1] 527 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Royal Melbourne Hospital
Grattan St
Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 428 0
None
Name [1] 428 0
None
Address [1] 428 0
Country [1] 428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1528 0
Royal Melbourne Hospital
Ethics committee address [1] 1528 0
Parkville, VIC, 3050.
Ethics committee country [1] 1528 0
Australia
Date submitted for ethics approval [1] 1528 0
Approval date [1] 1528 0
10/12/2004
Ethics approval number [1] 1528 0
2004.109

Summary
Brief summary
The purpose of this study is to determine the effects of nitrous oxide on the EEG, by randomising patients to inhaled induction of anaesthesia using nitrous oxide 33% or 66% or 0% with sevoflurane
Trial website
Trial related presentations / publications
Liley DT, LESLIE K, Sinclair NC, Feckie M. Dissociating the effects of nitrous oxide on brain electrical activity using fixed order time series modeling. Computers in Biology and Medicine 2008: 38:1121-30
Public notes

Contacts
Principal investigator
Name 35946 0
Miss Kate Leslie
Address 35946 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia
Country 35946 0
Australia
Phone 35946 0
61-418-374071
Fax 35946 0
Email 35946 0
kate.leslie@mh.org.au
Contact person for public queries
Name 9495 0
Prof Associate Professor Kate Leslie
Address 9495 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 9495 0
Australia
Phone 9495 0
+61 3 93427000
Fax 9495 0
+61 3 93428623
Email 9495 0
kate.leslie@mh.org.au
Contact person for scientific queries
Name 423 0
Prof Associate Professor Kate Leslie
Address 423 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 423 0
Australia
Phone 423 0
+61 3 93427000
Fax 423 0
+61 3 93428623
Email 423 0
kate.leslie@mh.org.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary