Effects of Low Concentrations of Nitrous Oxide

Nitrous Oxide Poisoning Clinical Trial

Official title:

Effects of Low Concentrations of Nitrous Oxide on Cognitive Functions and Reaction Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050267
• Other study ID #: VentRes-2019-02-KR
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: April 29, 2019

Study information

• Verified date: August 2019
• Source: Czech Technical University in Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to test the effects of low concentrations of nitrous oxide on cognitive functions and reaction time in human.

Description:

Nitrous oxide is a widely used gas in medicine, in standard concentrations above 50%. Its favourable physical properties and easy detectability by anaesthetic gas analysors predispose nitrous oxide to become a possible "tracing gas" for leak detection in experiments in which modified breathing system are in use. In these breathing experiments, the inspired concentrations of nitrous oxide would be well below the anaesthetic/analgesic concentrations. The aim of this study is to investigate the effects of these low concentrations of nitrous oxide (5, 7, 10, 12, 15, 20 %), compared to placebo (air, 0% nitrous oxide). The cognitive functions are tested using Digit Symbol Substitution Test, Reaction Time and Visual Analogue Scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 29, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• healthy volunteers from the Czech Technical University

Exclusion Criteria:

• pregnancy

• allergy to nitrous oxide

• severe asthma or other severe respiratory conditions

• severe cardiovascular conditions

Related Conditions & MeSH terms

• Nitrous Oxide Poisoning
• Poisoning

Intervention

Drug:
• Nitrous Oxide
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.

Other:
• Placebo - air
Breathing air with 21 % oxygen, no nitrous oxide.

Locations

Country	Name	City	State
Czechia	Czech Technical University	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive test results	The results of cognitive test performed during inhalation of defined concentration of nitrous oxide. Cognitive tests: Digit Symbol Substitution Test (DSST).	Through study completion, an average of 1 year
Primary	Reaction Time	The results of reaction time test performed during inhalation of defined concentration of nitrous oxide. Reaction Time (in seconds) using a computer-based test.	Through study completion, an average of 1 year