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

This study has been completed.
Sponsor:
Collaborator:
Australian and New Zealand College of Anaesthetists
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00226837
First received: September 26, 2005
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Breeze, Cortical Dynamics
ClinicalTrials.gov Identifier: NCT00226837     History of Changes
Other Study ID Numbers: 2004.109
Study First Received: September 26, 2005
Last Updated: February 3, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on May 23, 2013