Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborators:
Robert L. Bacon Medical Foundation
Research to Prevent Blindness
Information provided by (Responsible Party):
Kirk Lalwani, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00967694
First received: August 27, 2009
Last updated: September 15, 2014
Last verified: September 2014
Results First Received: April 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Diagnostic
Conditions: Glaucoma
Sedation
Intervention: Drug: Nitrous oxide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nitrous Oxide Administration All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.

Participant Flow:   Overall Study
    Nitrous Oxide Administration  
STARTED     26  
COMPLETED     20 [1]
NOT COMPLETED     6  
Withdrawal by Subject                 6  
[1] 5 discontinued during N2O administration due to agitation ⁄ dysphoria, one due to nausea⁄vomiting.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Volunteers recruited via locally placed posters, research opportunities website and email servers. Power calculations estimated 20 subjects would be needed to detect a 2.8mmHg difference in IOP. 26 subjects began nitrous oxide administration, with 6 choosing to withdraw. Baseline analysis based on the 20 participants completing the study.

Reporting Groups
  Description
Nitrous Oxide Administration All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.

Baseline Measures
    Nitrous Oxide Administration  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean ± Standard Deviation
  29.6  ± 6.7  
Gender  
[units: participants]
 
Female     12  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     26  
American Society of Anesthesiologists Physical Classification System (ASA) class [1]
[units: units on a scale]
Mean ± Standard Deviation
  1.1  ± 0.307  
Baseline Mean Intraocular Pressure (IOP)  
[units: mmHg]
Mean ± Standard Deviation
  11.0  ± 2.4  
Baseline Mean Arterial Pressure  
[units: mmHg]
Mean ± Standard Deviation
  86.4  ± 6.8  
[1]

Scale Range 1 to 6 with one being better, 6 being worst.

ASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease ASA Physical Status 4 - A patient with severe systemic disease that is a constant threat to life ASA Physical Status 5 - A moribund patient who is not expected to survive without the operation ASA Physical Status 6 - A declared brain-dead patient whose organs are being removed for donor purposes




  Outcome Measures

1.  Primary:   Change in Intraocular Pressure During Nitrous Oxide Sedation   [ Time Frame: Before, during and after administration of nitrous oxide (45 minutes total) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Eric Fox
Organization: University of Utah Department of Anesthesiology
phone: 775-340-0219
e-mail: ericbfox@yahoo.com


No publications provided


Responsible Party: Kirk Lalwani, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00967694     History of Changes
Other Study ID Numbers: IRB00005402
Study First Received: August 27, 2009
Results First Received: April 24, 2014
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board