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

Primary Purpose

Glaucoma, Sedation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nitrous oxide
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Nitrous oxide

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • OHSU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitrous oxide administration

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Intraocular Pressure During Nitrous Oxide Sedation

Secondary Outcome Measures

Full Information

First Posted
August 27, 2009
Last Updated
September 15, 2014
Sponsor
Oregon Health and Science University
Collaborators
Robert L. Bacon Medical Foundation, Research to Prevent Blindness
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1. Study Identification

Unique Protocol Identification Number
NCT00967694
Brief Title
Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers
Official Title
Effect of N2O on Intraocular Pressure in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Robert L. Bacon Medical Foundation, Research to Prevent Blindness

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
An initial pre-anesthetic evaluation and physical examination will be performed by an attending anesthesiologist, and an eye exam will be performed by an attending ophthalmologist to determine suitability for inclusion according to the above criteria. Ideally the eye exam will take place immediately prior to conduction of the study. However, logistical restraints may require that the eye exam take place at a separate time/date prior to conduction of the study. IOPs will be measured by the attending ophthalmologist (B.E.) who will be blinded to the actual readings of the Tonopen by means of a small screen, and a single trained observer (E.F.) will record observations from the Tonopen. The nitrous oxide sedation will be managed by the attending anesthesiologist (K.L.). All patients will be monitored throughout using standardized monitoring (continuous EKG, non-invasive BP, and continuous pulse oximetry).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Sedation
Keywords
Glaucoma, Nitrous oxide

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrous oxide administration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitrous oxide
Other Intervention Name(s)
N2O
Intervention Description
Nitrous oxide sedation by inhalation
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure During Nitrous Oxide Sedation
Time Frame
Before, during and after administration of nitrous oxide (45 minutes total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk Lalwani, MD,FRCA,MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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

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