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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group - air | Placebo Comparator | Breathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol. |
|
| Intervention Group - 5% nitrous oxide | Experimental | Breathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
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| Intervention Group - 7% nitrous oxide | Experimental | Breathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
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| Intervention Group - 10% nitrous oxide | Experimental | Breathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
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| Intervention Group - 12% nitrous oxide | Experimental | Breathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
|
| Intervention Group - 15% nitrous oxide |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide | Drug | Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karel Roubik, prof., Ph.D. | Czech Technical University in Prague | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Czech Technical University | Prague | Czechia |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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All participants go through all study arms, in random order.
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| Experimental |
Breathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
|
| Intervention Group - 20% nitrous oxide | Experimental | Breathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol. |
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| Placebo - air | Other | Breathing air with 21 % oxygen, no nitrous oxide. |
|
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |