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Measurement of the Second Gas Effect on Sevoflurane in Anaesthetised Patients

Measurement of the Second Gas Effect on Sevoflurane in Anaesthetised Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00321191
Enrollment
14
Registered
2006-05-03
Start date
2006-05-31
Completion date
2006-09-30
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Detailed description

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.

Interventions

DRUGAdministration of N2O

Sponsors

Austin Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026