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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
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Glaucoma Sedation Drug: Nitrous oxide Phase 4

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions

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.
Drug: Nitrous oxide
Nitrous oxide sedation by inhalation
Other Name: N2O

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Oregon Health and Science University
Robert L. Bacon Medical Foundation
Research to Prevent Blindness
Principal Investigator: Kirk Lalwani, MD,FRCA,MCR Oregon Health and Science University
More Information

Responsible Party: Kirk Lalwani, Associate Professor, Anesthesiology and Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00967694     History of Changes
Other Study ID Numbers: IRB00005402
First Posted: August 28, 2009    Key Record Dates
Results First Posted: September 23, 2014
Last Update Posted: September 23, 2014
Last Verified: September 2014

Keywords provided by Kirk Lalwani, Oregon Health and Science University:
Nitrous oxide

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents