The effects of nitrous oxide on human visio

Phase 1

Conditions: effects on vision:- accomodation- visual acuity- binocularity- stereopsis- colour vision- pupil reflex- eye movements
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2018-000045-40-BE

Lead Sponsor: niversitair ziekenhuis Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

- Subjects between 18 and 25 years old
- Men and women in good health (ASA I).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Younger than 18 years or older than 25 years
- Sick people or people having a cold (risk for the eardrum)
- volunteers with lung disorders (because of the inhalation of the gas)
- No pregnant subjects.
- At least 24 h before the experiment, volunteers should be free of party drugs or other medication.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the effects of nitrous oxide on human vision ;Secondary Objective: N/A;Primary end point(s): Visus;Timepoint(s) of evaluation of this end point: After 10 minutes of administration of nitrous oxide

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - accommodation<br>- binocularity<br>- stereopsis<br>- colour vision<br>- pupil reflex<br>- eye movements.<br>- Alteration of mental status;Timepoint(s) of evaluation of this end point: After 10 minutes of administration of nitrous oxide