Trial Outcomes & Findings for Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers (NCT NCT00967694)

Last Updated: 2014-09-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Before, during and after administration of nitrous oxide (45 minutes total)

Results posted on

2014-09-23

Participant milestones
Measure	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.
Overall Study STARTED	26
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	6

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

Baseline characteristics by cohort
Measure	Nitrous Oxide Administration n=26 Participants 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.
Age, Continuous	29.6 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
American Society of Anesthesiologists Physical Classification System (ASA) class	1.1 units on a scale STANDARD_DEVIATION 0.307 • n=5 Participants
Baseline Mean Intraocular Pressure (IOP)	11.0 mmHg STANDARD_DEVIATION 2.4 • n=5 Participants
Baseline Mean Arterial Pressure	86.4 mmHg STANDARD_DEVIATION 6.8 • n=5 Participants

Timeframe: Before, during and after administration of nitrous oxide (45 minutes total)

Outcome measures
Measure	Nitrous Oxide Administration n=20 Participants All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline (prior to nitrous oxide administration) 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 one study arm, with each individual serving as their control for baseline (before nitrous oxide administration) and then intervention values of IOP measurement (during nitrous oxide administration), and then washout values of IOP (after breathing room air).
Change in Intraocular Pressure During Nitrous Oxide Sedation	1.05 mmHg (difference in IOP) Interval -0.81 to 2.9

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Nitrous Oxide Administration n=26 participants at risk 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.
Gastrointestinal disorders Nausea/vomiting	3.8% 1/26 • Number of events 1 • 1 week
Nervous system disorders Dysphoria	19.2% 5/26 • Number of events 5 • 1 week

University of Utah Department of Anesthesiology

Phone: 775-340-0219