NCT00226837

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

September 26, 2005

Last Update Submit

February 3, 2009

Conditions

Depth of Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • EEG index value during three concentrations of nitrous oxide

    During induction of anaesthesia

Study Arms (3)

1

PLACEBO COMPARATOR

0% nitrous oxide

Drug: Nitrous oxide

2

ACTIVE COMPARATOR

33% nitrous oxide

Drug: Nitrous oxide

3

ACTIVE COMPARATOR

66% nitrous oxide

Drug: Nitrous oxide

Interventions

Nitrous oxideDRUG

nitrous oxide by inhalation during induction

Also known as: No other names were used
123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Presenting for surgery under general anaesthesia

You may not qualify if:

  • Poor English language comprehension
  • Risk of reflux
  • Epilepsy or other EEG abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Swinburne University

Hawthorn, Victoria, 3123, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Kate Leslie, MD

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 27, 2005

Study Start

August 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

AU(2)