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

Glaucoma Clinical Trial

Official title:

Effect of N2O on Intraocular Pressure in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967694
• Other study ID #: IRB00005402
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2009
• Last updated: September 15, 2014
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma
• Sedation

Intervention

Drug:
• Nitrous oxide
Nitrous oxide sedation by inhalation

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Research to Prevent Blindness, Robert L. Bacon Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Pressure During Nitrous Oxide Sedation		Before, during and after administration of nitrous oxide (45 minutes total)	No