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

Status

Completed

Conditions

Intervention / Treatment

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

  • Australia
    • 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
Drug: Nitrous oxide
nitrous oxide by inhalation during induction
Other Names:
  • No other names were used
Active Comparator: 2
33% nitrous oxide
Drug: Nitrous oxide
nitrous oxide by inhalation during induction
Other Names:
  • No other names were used
Active Comparator: 3
66% nitrous oxide
Drug: Nitrous oxide
nitrous oxide by inhalation during induction
Other Names:
  • No other names were used

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

Melbourne Health

Collaborators

Australian and New Zealand College of Anaesthetists

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.

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