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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00226837




Registration number
NCT00226837
Ethics application status
Date submitted
26/09/2005
Date registered
27/09/2005
Date last updated
5/02/2009

Titles & IDs
Public title
Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling
Scientific title
Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling
Secondary ID [1] 0 0
2004.109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depth of Anaesthesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nitrous oxide

Placebo Comparator: 1 - 0% nitrous oxide

Active Comparator: 2 - 33% nitrous oxide

Active Comparator: 3 - 66% nitrous oxide


Treatment: Drugs: Nitrous oxide
nitrous oxide by inhalation during induction
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
EEG index value during three concentrations of nitrous oxide
Timepoint [1] 0 0
During induction of anaesthesia

Eligibility
Key inclusion criteria
- Aged 18 years or older

- Presenting for surgery under general anaesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Poor English language comprehension

- Risk of reflux

- Epilepsy or other EEG abnormality

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2005
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University - Hawthorn
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3123 - Hawthorn
Recruitment postcode(s) [2] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand College of Anaesthetists
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically
based time series modelling will result in improved ability to determine nitrous oxide
anaesthetic effect
Trial website
https://clinicaltrials.gov/ct2/show/NCT00226837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Leslie, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00226837