Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling
February 3, 2009 updated by: Melbourne Health
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
Study Overview
Detailed Description
We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Hawthorn, Victoria, Australia, 3123
- Swinburne University
-
Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 years or older
- Presenting for surgery under general anaesthesia
Exclusion Criteria:
- Poor English language comprehension
- Risk of reflux
- Epilepsy or other EEG abnormality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 1
0% nitrous oxide
|
nitrous oxide by inhalation during induction
Other Names:
|
|
Active Comparator: 2
33% nitrous oxide
|
nitrous oxide by inhalation during induction
Other Names:
|
|
Active Comparator: 3
66% nitrous oxide
|
nitrous oxide by inhalation during induction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
EEG index value during three concentrations of nitrous oxide
Time Frame: During induction of anaesthesia
|
During induction of anaesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate Leslie, MD, Melbourne Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
August 1, 2005
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
September 26, 2005
First Submitted That Met QC Criteria
September 26, 2005
First Posted (Estimate)
September 27, 2005
Study Record Updates
Last Update Posted (Estimate)
February 5, 2009
Last Update Submitted That Met QC Criteria
February 3, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004.109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.