Glaucoma, Sedation
Conditions
Keywords
Glaucoma, Nitrous oxide
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).
Interventions
DRUGNitrous oxide
Nitrous oxide sedation by inhalation
Sponsors
Robert L. Bacon Medical Foundation
Research to Prevent Blindness
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Intraocular Pressure During Nitrous Oxide Sedation | Before, during and after administration of nitrous oxide (45 minutes total) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Nitrous Oxide Administration |
|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 6.7 |
| American Society of Anesthesiologists Physical Classification System (ASA) class | 1.1 units on a scale STANDARD_DEVIATION 0.307 |
| Baseline Mean Arterial Pressure | 86.4 mmHg STANDARD_DEVIATION 6.8 |
| Baseline Mean Intraocular Pressure (IOP) | 11.0 mmHg STANDARD_DEVIATION 2.4 |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Change in Intraocular Pressure During Nitrous Oxide Sedation
Time frame: Before, during and after administration of nitrous oxide (45 minutes total)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nitrous Oxide Administration | Change in Intraocular Pressure During Nitrous Oxide Sedation | 1.05 mmHg (difference in IOP) |
Comparison: A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p \< 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25p-value: >0.05Mixed Models Analysis