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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00321191




Registration number
NCT00321191
Ethics application status
Date submitted
2/05/2006
Date registered
3/05/2006
Date last updated
24/06/2015

Titles & IDs
Public title
Measurement of the Second Gas Effect on Sevoflurane in Anaesthetised Patients
Scientific title
Measurement of the Second Gas Effect on Sevoflurane in Anaesthetised Patients
Secondary ID [1] 0 0
02531
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - No nitrous oxide
Treatment: Drugs - Administration of N2O

Experimental: N2O -

Placebo Comparator: No N2O -


Treatment: Drugs: No nitrous oxide


Treatment: Drugs: Administration of N2O
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fa/FI sevoflurane in 100% O2 vs in 70% N2O and 30% O2 during 1st 60 min anaesthesia
Timepoint [1] 0 0
Primary outcome [2] 0 0
Change in Fa/FI sevoflurane in 100% O2 vs in 70% N2O and 30% O2 after 60 minutes anaesthesia
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Fa/FI and FA/FI for N2O will also be recorded.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Patients scheduled for elective surgery requiring relaxant general anaesthesia with
arterial blood pressure monitoring via an arterial line.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00321191
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip J Peyton, MD FANZCA
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00321191