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Physiological Effects of Nitrous Oxide on Anaesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Philip Peyton, Austin Health
ClinicalTrials.gov Identifier:
NCT01092923
First received: March 10, 2010
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
Results First Received: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Anesthesia
Interventions: Drug: sevoflurane on air/O2
Drug: sevoflurane in N2O/O2

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of recruitment: December 2009 to April 2010 Location: Austin Health

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria: patients with history of severe lung disease (defined as FEV1<1.5 L or FEV1/FVC<50%), symptomatic ischemic heart disease, super obesity (BMI>45), pregnancy, prior severe post-operative nausea/vomiting, critically ill/immunocompromised, Vitamin B12/folate deficiency, or presence of any gas-filled, space-occupying lesion.

Reporting Groups
  Description
Air/Oxygen Sevoflurane with Air/Oxygen Mix
Sevoflurane in N2O/O2 Sevoflurane in 2:1 N2O/O2

Participant Flow:   Overall Study
    Air/Oxygen     Sevoflurane in N2O/O2  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Air/Oxygen Sevoflurane with Air/Oxygen Mix
Sevoflurane in N2O/O2 Sevoflurane in 2:1 N2O/O2
Total Total of all reporting groups

Baseline Measures
    Air/Oxygen     Sevoflurane in N2O/O2     Total  
Number of Participants  
[units: participants]
 		  10     10     20  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     3     5     8  
>=65 years     7     5     12  
Age  
[units: years]
Mean ± Standard Deviation 		  65  ± 18     67  ± 13     66  ± 16  
Gender  
[units: participants]
 		     
Female     5     6     11  
Male     5     4     9  
Region of Enrollment  
[units: participants]
 		     
Australia     10     10     20  



  Outcome Measures
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1.  Primary:   Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)   [ Time Frame: Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence ]
  Show Outcome Measure 1

2.  Primary:   PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)   [ Time Frame: Baseline, 2 minutes, and 5 minutes after emergence ]
  Show Outcome Measure 2

3.  Secondary:   Time to Eye Opening   [ Time Frame: 20 Minutes ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr Phil Peyton
Organization: Austin Health
phone: 9496 5000 ext 5704
e-mail: phil.peyton@austinhealth.org.au


No publications provided


Responsible Party: Dr Philip Peyton, Austin Health
ClinicalTrials.gov Identifier: NCT01092923     History of Changes
Other Study ID Numbers: 03749
Study First Received: March 10, 2010
Results First Received: February 16, 2012
Last Updated: September 11, 2012
Health Authority: Australia: National Health and Medical Research Council