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

NCT ID: NCT00967694

Last Updated: 2014-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-10-31

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).

Conditions

Glaucoma; Sedation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nitrous oxide

Intervention Type: DRUG

Nitrous oxide sedation by inhalation

Interventions

Nitrous oxide

Nitrous oxide sedation by inhalation

Intervention Type: DRUG

Other Intervention Names

N2O

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert L. Bacon Medical Foundation

UNKNOWN

Sponsor Role: collaborator

Research to Prevent Blindness

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Kirk Lalwani

Associate Professor, Anesthesiology and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirk Lalwani, MD,FRCA,MCR

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

OHSU

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB00005402

Identifier Type: -

Identifier Source: org_study_id