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

Phase 4

Completed

• Conditions: Depth of Anaesthesia
• Interventions: Drug: Nitrous oxide

• Registration Number: NCT00226837
• Lead Sponsor: Melbourne Health

Brief 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

Detailed Description

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

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-27
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Nitrous oxide	33% nitrous oxide
3	Nitrous oxide	66% nitrous oxide
1	Nitrous oxide	0% nitrous oxide

Primary Outcome Measures

Name	Time	Method
EEG index value during three concentrations of nitrous oxide	During induction of anaesthesia

Trial Locations

Locations (2)

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

Swinburne University; 🇦🇺 Hawthorn, Victoria, Australia