NCT00146250

Brief Summary

Nitrous oxide is a standard part of most anaesthetic breathing mixtures. It has often been assumed that it reduces the amount of oxygen reaching the lower parts of the lung. However the results of previous studies and of some computer modelling suggests the opposite may be true, and that oxygen levels in the blood are actually higher with nitrous oxide. This study seeks to determine whether nitrous oxide increases or decreases blood oxygen levels in anaesthetized patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2005

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

September 6, 2005

Last Update Submit

January 9, 2018

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • PaO2

    Measured change in PaO2 after a minimum of 30 minutes of general anaesthesia, following sternotomy, in the two groups.

    Minimum of 30 minutes after induction of anaesthesia

Secondary Outcomes (1)

  • Change in pulmonary deadspace and shunt fractions

    Minimum of 30 minutes after induction of anaesthesia

Study Arms (2)

Nitrous oxide

EXPERIMENTAL

Nitrous oxide 70% as balance gas in inspired mixture

Drug: Nitrous oxide

Nitrogen

EXPERIMENTAL

Nitrogen instead of nitrous oxide 70% as balance gas in inspired mixture

Drug: Nitrous oxide

Interventions

Nitrous oxideDRUG

Substitution of Nitrous oxide for Nitrogen as balance gas in inspired gas mixture

Also known as: N2O
NitrogenNitrous oxide

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective coronary artery bypass surgery

You may not qualify if:

  • Age under 18 years, emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Philip J Peyton, MD FANZCA

    Dept of Anaesthesia, Austin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

March 1, 2005

Primary Completion

July 20, 2005

Study Completion

September 30, 2005

Last Updated

January 11, 2018

Record last verified: 2018-01