- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967694
Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers
Effect of N2O on Intraocular Pressure in Healthy Volunteers
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- OHSU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 18-40
- American Society of Anesthesiologists Physical Classification System (ASA) Status 1-2
- Nil per os (NPO) prior to study (2 hrs clear liquids, 4 hrs milk, 6 hrs light food, 8 hrs heavy/greasy food)
Exclusion Criteria:
- Lack of volunteer consent
- Pregnancy
- History of features suggestive of a difficult airway on pre-anesthetic evaluation and physical examination
- Active gastroesophageal reflux disease
- Active obstructive sleep apnea
- History of recent trauma
- History of pneumothorax or lung cyst
- History of Vitamin B12 deficiency
- History of recent middle ear surgery (<3months)
- Current or recent (<3 weeks) respiratory tract infection
- Any acute illness or exacerbation of chronic illness such as asthma, chronic lung disease etc.
- Any history of cardiac ischemia (angina), myocardial infarction, or cardiac dysrhythmia.
- Myopia greater than -3 spherical equivalents or hyperopia greater than +3 spherical equivalents
- History of eye surgery of any sort, including refractive surgery, cataracts, and vitrectomy
- History of any ocular disease or infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Nitrous oxide sedation by inhalation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Intraocular Pressure During Nitrous Oxide Sedation
Time Frame: Before, during and after administration of nitrous oxide (45 minutes total)
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Before, during and after administration of nitrous oxide (45 minutes total)
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Collaborators and Investigators
Investigators
- Principal Investigator: Kirk Lalwani, MD,FRCA,MCR, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00005402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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