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临床试验/NCT06203522
NCT06203522已完成不适用

Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin: an Observational Study

Centre Hospitalier Régional Metz-Thionville1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images.

研究概览

简要总结

This is a retrospective cohort study aiming to determine whether the use of Dexmedetomidine (DEX) to sedate children prior to MRI scanning is more or less effective in children with autism spectrum disorders or other neurodevelopmental disorders compared to other children.

详细描述

Performing brain MRI on children under 5, or in cases of autism or disability, is often complex. In fact, this examination requires total immobilization of the child for at least 20 minutes. The noise and the fact that the child is lying in a sort of tunnel add to the child's stress.

General anesthesia with propofol is widely used in France, but requires invasive orotracheal intubation or mask ventilation. There are no national or international recommendations for pediatric MRI sedation procedures.

Intranasal dexmedetomidine (DEX) is used for brain MRI, cardiac ultrasound, ophthalmology, dental treatment and brain computed tomography (CT) in patients aged 3 months to 12 years. Its superior efficacy has been demonstrated in a number of studies compared with the most commonly used medicated procedural sedation techniques, but only one study in France has prospectively analyzed the efficacy of DEX IN for performing cerebral MRIs, but without assessing efficacy and tolerance in subgroups of children: with or without neurodevelopmental disorders, epilepsy, autism, age.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients under 18 years of age sedated with DEX IN prior to MRI.

排除标准

  • incomplete or missing medical records

结局指标

主要结局

Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images.

时间窗: Immediately after procedure

Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images (yes/no)

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (1)

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