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

Depth of Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226837
• Other study ID #: 2004.109
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2005
• Last updated: February 3, 2009
• Start date: August 2004
• Est. completion date: August 2005

Study information

• Verified date: February 2009
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depth of Anaesthesia

Intervention

Drug:
• Nitrous oxide
nitrous oxide by inhalation during induction

Locations

Country	Name	City	State
Australia	Swinburne University	Hawthorn	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Melbourne Health	Australian and New Zealand College of Anaesthetists

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG index value during three concentrations of nitrous oxide		During induction of anaesthesia	No