NCT00321191

Brief Summary

This study is investigating the "second gas effect", a phenomenon produced by the uptake of nitrous oxide (N2O) by the lungs, during the course of a typical anaesthetic. The effect is to increase the concentration of other breathed gases in the lung. These include oxygen and volatile anaesthetic agents such as sevoflurane, which are also normally administered along with N2O. We wish to i) measure the magnitude of the second gas effects on both blood and expired concentrations of sevoflurane (Part 1), and ii) see if a demonstrable difference exists between the effects on blood and expired concentrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 24, 2015

Status Verified

August 1, 2008

First QC Date

May 2, 2006

Last Update Submit

June 23, 2015

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (2)

  • Fa/FI sevoflurane in 100% O2 vs in 70% N2O and 30% O2 during 1st 60 min anaesthesia

  • Change in Fa/FI sevoflurane in 100% O2 vs in 70% N2O and 30% O2 after 60 minutes anaesthesia

Secondary Outcomes (1)

  • Fa/FI and FA/FI for N2O will also be recorded.

Study Arms (2)

N2O

EXPERIMENTAL
Drug: Administration of N2O

No N2O

PLACEBO COMPARATOR
Drug: No nitrous oxide

Interventions

No nitrous oxideDRUG
No N2O
Administration of N2ODRUG
N2O

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective surgery requiring relaxant general anaesthesia with arterial blood pressure monitoring via an arterial line.

You may not qualify if:

  • Patients with moderately or severely impaired respiratory disease (FEV1 \< 1.5L, or FVC \< 2.0L).
  • Patients under 18 years of age.
  • Morbidly obese patients: BMI \> 30
  • Patients unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

Study Officials

  • Philip J Peyton, MD FANZCA

    Austin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 3, 2006

Study Start

May 1, 2006

Study Completion

September 1, 2006

Last Updated

June 24, 2015

Record last verified: 2008-08

Locations

AU(1)