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临床试验/NCT04050267
NCT04050267已完成不适用

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

Czech Technical University in Prague1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年4月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Cognitive test results

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers from the Czech Technical University

排除标准

  • pregnancy
  • allergy to nitrous oxide
  • severe asthma or other severe respiratory conditions
  • severe cardiovascular conditions

研究组 & 干预措施

Intervention Group - 20% nitrous oxide

Experimental

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

干预措施: Nitrous Oxide (Drug)

Control group - air

Placebo Comparator

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

干预措施: Placebo - air (Other)

Intervention Group - 5% nitrous oxide

Experimental

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

干预措施: Nitrous Oxide (Drug)

Intervention Group - 7% nitrous oxide

Experimental

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

干预措施: Nitrous Oxide (Drug)

Intervention Group - 10% nitrous oxide

Experimental

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

干预措施: Nitrous Oxide (Drug)

Intervention Group - 12% nitrous oxide

Experimental

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

干预措施: Nitrous Oxide (Drug)

Intervention Group - 15% nitrous oxide

Experimental

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

干预措施: Nitrous Oxide (Drug)

结局指标

主要结局

Cognitive test results

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Effects of Low Concentrations of Nitrous Oxide | 临床试验