Effects of Low Concentrations of Nitrous Oxide

Czech Technical University in Prague

Status: Completed

Conditions: Nitrous Oxide Poisoning

Treatments: Drug: Nitrous Oxide; Other: Placebo - air

Study type: Interventional

Funder types: Other

Identifiers

NCT04050267

VentRes-2019-02-KR

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 7 patient groups, including a placebo group

Control group - air

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo - air

Intervention Group - 5% nitrous oxide

Experimental group

Description:

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

Treatment:

Drug: Nitrous Oxide

Intervention Group - 7% nitrous oxide

Experimental group

Description:

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

Treatment:

Drug: Nitrous Oxide

Intervention Group - 10% nitrous oxide

Experimental group

Description:

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

Treatment:

Drug: Nitrous Oxide

Intervention Group - 12% nitrous oxide

Experimental group

Description:

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

Treatment:

Drug: Nitrous Oxide

Intervention Group - 15% nitrous oxide

Experimental group

Description:

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

Treatment:

Drug: Nitrous Oxide

Intervention Group - 20% nitrous oxide

Experimental group

Description:

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

Treatment:

Drug: Nitrous Oxide