Effects of Low Concentrations of Nitrous Oxide

NCT ID: NCT04050267

Last Updated: 2019-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2019-04-29

Brief Summary

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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

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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.

Conditions

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Nitrous Oxide Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants go through all study arms, in random order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group - air

Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol.

Group Type PLACEBO_COMPARATOR

Placebo - air

Intervention Type OTHER

Breathing air with 21 % oxygen, no nitrous oxide.

Intervention Group - 5% nitrous oxide

Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

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

Intervention Group - 7% nitrous oxide

Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

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

Intervention Group - 10% nitrous oxide

Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

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

Intervention Group - 12% nitrous oxide

Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

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

Intervention Group - 15% nitrous oxide

Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

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

Intervention Group - 20% nitrous oxide

Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

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

Interventions

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Nitrous Oxide

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

Intervention Type DRUG

Placebo - air

Breathing air with 21 % oxygen, no nitrous oxide.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Czech Technical University in Prague

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karel Roubik, prof., Ph.D.

Role: STUDY_DIRECTOR

Czech Technical University in Prague

Locations

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Czech Technical University

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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VentRes-2019-02-KR

Identifier Type: -

Identifier Source: org_study_id

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