Effects of Low Concentrations of Nitrous Oxide

Not Applicable

Completed

• Conditions: Nitrous Oxide Poisoning
• Interventions: Drug: Nitrous Oxide; Other: Placebo - air

• Registration Number: NCT04050267
• Lead Sponsor: Czech Technical University in Prague

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-25
• Primary Completion: 2019-04-29
• Study Completion: 2019-04-29
• Study First Submitted: 2019-05-15
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-07
• Study First Posted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Group - 5% nitrous oxide	Nitrous Oxide	Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Control group - air	Placebo - air	Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol.
Intervention Group - 12% nitrous oxide	Nitrous Oxide	Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 15% nitrous oxide	Nitrous Oxide	Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 20% nitrous oxide	Nitrous Oxide	Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 7% nitrous oxide	Nitrous Oxide	Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 10% nitrous oxide	Nitrous Oxide	Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Czech Technical University; 🇨🇿 Praha, Czechia