Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00967694|
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : September 23, 2014
Last Update Posted : September 23, 2014
The purpose of this study is to learn if breathing nitrous oxide (also known as "laughing gas") changes the pressure in a person's eyes. Some patients who need regular eye exams to measure their eye pressure often need to be put to sleep with medicine in order to complete the eye exam. Some of these medicines are known to cause changes in a person's eye pressure. Because of this, such medicines are avoided if the eye doctor needs to measure the patient's eye pressure. One medicine that is frequently used to put patients to sleep is nitrous oxide. No one really knows what effect nitrous oxide might have on a persons' eye pressure. The investigators are interested to see if nitrous oxide causes an increase, decrease, or no change in eye pressure. The investigators also want to investigate if there is a difference in the effects of nitrous oxide on eye pressure between males and females. Understanding these effects of nitrous oxide is important because during such eye exams, the eye doctor uses the pressure measurements to make important decisions about treatment and surgery options for the patient.
The investigators hypothesize that the use of inhaled nitrous oxide (N2O) will result in a decrease in IOP in healthy volunteers.
The investigators aim to determine the magnitude and duration of change, if any, in IOP caused by inhalation of N2O, and to assess if the gender of the patient has a role in this effect.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma Sedation||Drug: Nitrous oxide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effect of N2O on Intraocular Pressure in Healthy Volunteers|
|Study Start Date :||August 2009|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
Experimental: 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.
Drug: Nitrous oxide
Nitrous oxide sedation by inhalation
Other Name: N2O
- Change in Intraocular Pressure During Nitrous Oxide Sedation [ Time Frame: Before, during and after administration of nitrous oxide (45 minutes total) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967694
|United States, Oregon|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Kirk Lalwani, MD,FRCA,MCR||Oregon Health and Science University|