Measurement of the Second Gas Effect on Sevoflurane in Anaesthetised Patients

NCT ID: NCT00321191

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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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.

While the second gas effect has been demonstrated previously, by measuring the concentration of volatile anaesthetic in the expired breath, no study has yet shown that it has a significant effect on the concentrations in the blood. The blood concentration is in fact more important, as it directly determines the concentration of anaesthetic reaching the brain, and therefore the effect on the depth of anaesthesia. The second gas effect on blood concentrations may be more powerful than that on expired concentrations, due to the detrimental effect of anaesthesia on the evenness of distribution of ventilation and blood flow in the lung.

The proposed study will have two parallel components or Parts. 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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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N2O

Group Type EXPERIMENTAL

Administration of N2O

Intervention Type DRUG

No N2O

Group Type PLACEBO_COMPARATOR

No nitrous oxide

Intervention Type DRUG

Interventions

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No nitrous oxide

Intervention Type DRUG

Administration of N2O

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austin Health

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Philip J Peyton, MD FANZCA

Role: PRINCIPAL_INVESTIGATOR

Austin Health

Locations

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Austin Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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02531

Identifier Type: -

Identifier Source: org_study_id

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