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临床试验/NCT04095494
NCT04095494已完成不适用

Study Of the Nitrous Oxide Perception in Health Students

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
nitrous oxide use in the form of EMONO

研究概览

简要总结

In order to evaluate the perception of the Nantes health students we wish to place an anonymous survey concerning their training, their knowledge of the legislative framework governing the use of EMONO and their personal and professional experience around nitrous oxide.

详细描述

The use of nitrous oxide in the form of EMONO (Equimolar Mixture of Nitrous Oxide and Oxygen) is common practice in the medical field in France since obtaining the AMM in France in 2001. It is used daily in the hospital services for its analgesic and anxiolytic properties in order to obtain a conscious sedation of the patient during the realization of painful care. Its use in liberal practice has been authorized since 2009 in France following the confirmation of its security by clinical studies.

In its medical use, the use of nitrous oxide is subject to numerous regulations; EMONO's various presentations are on the I list of poisonous substances and are subject in part to the regulation of narcotics (secure storage, obligation to report flights ...) in France. The use of this substance can only be done under medical prescription, in adapted premises, by a medical or paramedical staff specifically trained, and whose knowledge will be periodically reevaluated. All conditions of use and storage of EMONO are specified in the French Code of Public Health (Article L5123-2) and, since it is authorized in a non-hospital environment, enhanced monitoring of pharmacovigilance and addictovigilance and a Risk Management Plan (RMP) has been put in place.

Paradoxically, apart from the supervised medical use, it is very simple to obtain nitrous oxide. It is found in particular in whipped cream cartridges in a pure concentration (100% N2O) over-the-counter and unregulated. In this form it is transferred into balloons by consumers in order to be inhaled. Also known as laughing gas, it is diverted from its original use for its euphoric properties and its effects (visual and sensory distortions) that last only a few minutes.

The regulations governing the use of nitrous oxide have been put in place because the toxicity of the latter is recognized in particular during chronic use. The risks associated with the acute consumption of nitrous oxide are essentially hypoxia with even cases of death recorded in the literature. Nitrous oxide consumed chronically can inactivate vitamin B12 by oxidizing its cobalt ion causing neurological pathologies (myoneuropathies).

The risks related to nitrous oxide are certainly rare but known. The fact that it can be easily obtained gives this "legal drug" a special status combining rare but existing side effects and the risk of public abuse.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Being an health students in Nantes University

排除标准

  • Refusal to participate

结局指标

主要结局

nitrous oxide use in the form of EMONO

时间窗: 5 minutes

Investigate the percentage of health students who had contact with EMONO Survey on the use of EMONO among health students

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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