Effects of Low Concentrations of Nitrous Oxide

August 7, 2019 updated by: Czech Technical University in Prague

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia
        • Czech Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group - air
Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol.
Other: Placebo - air
Breathing air with 21 % oxygen, no nitrous oxide.
Experimental: Intervention Group - 5% nitrous oxide
Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Drug: Nitrous Oxide
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
Experimental: Intervention Group - 7% nitrous oxide
Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Drug: Nitrous Oxide
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
Experimental: Intervention Group - 10% nitrous oxide
Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Drug: Nitrous Oxide
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
Experimental: Intervention Group - 12% nitrous oxide
Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Drug: Nitrous Oxide
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
Experimental: Intervention Group - 15% nitrous oxide
Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Drug: Nitrous Oxide
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
Experimental: Intervention Group - 20% nitrous oxide
Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Drug: Nitrous Oxide
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive test results
Time Frame: 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).
Through study completion, an average of 1 year
Reaction Time
Time Frame: 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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2019

Primary Completion (Actual)

April 29, 2019

Study Completion (Actual)

April 29, 2019

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VentRes-2019-02-KR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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