Quantifying Nitrous Oxide Effect on Depth of Anaesthesia... | NCT00226837

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

NCT00226837

Sponsor

Melbourne Health

Status

Completed

Last Update Posted

Feb 5, 2009Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Depth of Anaesthesia

Interventions

Nitrous oxide

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Sep 26, 2005

First Submission Date that Met QC Criteria

Sep 26, 2005

First Posted Date

Sep 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2009

Last Update Posted Date

Feb 5, 2009Estimated

Name	Class
Australian and New Zealand College of Anaesthetists	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nitrous oxide	Drug	nitrous oxide by inhalation during induction	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EEG index value during three concentrations of nitrous oxide		During induction of anaesthesia

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kate Leslie, MD	Melbourne Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swinburne University		Hawthorn	Victoria	3123	Australia
Royal Melbourne Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D009609	Nitrous Oxide

Ancestor Terms

ID	Term
D009589	Nitrogen Oxides
D005740	Gases
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds

Browse Leaves

Not provided

Browse Branches

Not provided