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Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226837
First Posted: September 27, 2005
Last Update Posted: February 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Australian and New Zealand College of Anaesthetists
Information provided by:
Melbourne Health
  Purpose
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

Condition Intervention Phase
Depth of Anaesthesia Drug: Nitrous oxide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • EEG index value during three concentrations of nitrous oxide [ Time Frame: During induction of anaesthesia ]

Enrollment: 60
Study Start Date: August 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
0% nitrous oxide
Drug: Nitrous oxide
nitrous oxide by inhalation during induction
Other Name: No other names were used
Active Comparator: 2
33% nitrous oxide
Drug: Nitrous oxide
nitrous oxide by inhalation during induction
Other Name: No other names were used
Active Comparator: 3
66% nitrous oxide
Drug: Nitrous oxide
nitrous oxide by inhalation during induction
Other Name: No other names were used

Detailed Description:
We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226837


Locations
Australia, Victoria
Swinburne University
Hawthorn, Victoria, Australia, 3123
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Australian and New Zealand College of Anaesthetists
Investigators
Principal Investigator: Kate Leslie, MD Melbourne Health
  More Information

Responsible Party: David Breeze, Cortical Dynamics
ClinicalTrials.gov Identifier: NCT00226837     History of Changes
Other Study ID Numbers: 2004.109
First Submitted: September 26, 2005
First Posted: September 27, 2005
Last Update Posted: February 5, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents