EUCTR2018-001466-42-FR进行中（未招募）1 期
EFFECTIVENESS OF INTRANASAL DEXMEDETOMIDINE FOR SEDATEDAUDITORY BRAINSTEM RESPONSE TESTING - DEXMEDETOMIDINE - ABR
Fondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVA0 个研究点目标入组 60 人开始时间: 2018年4月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Child aged 1 to 15 years old
- •-ASA 1 or 2 (American Society Anesthesiologists scale patient)
- •-Need to evaluate the child audition in a context of suspicion of
- •deafness, delay of language, global delay of the development, the risk
- •factors of hearing loss
- •-Impossibility to realize a hearing test by conventional audiogram or
- •behavioral due to a cognitive or behavioral disorder of the child
- •-Affiliation to social security scheme
- •-Signature of the authorization documents of the 2 parents or the
- •representative of the parental authority for the participation of the child
- •in the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Heart disease or heart rhythm disorder
- •- Pneumopathy or asthmatic crisis in previous 2 weeks in the
- •examination
- •- Recent used of digoxine or beta-blocker
- •- Use of anti-epileptic or psychotropic drugs
- •- Medical history of sleep apnea
- •- Receptor alpha2 agonist allergy
- •- Gastrooesophageal reflux disease
- •- Upper airway abnormality
- •- Acute cerebrovascular diseases
- •- Neurologic disorders ( cranial trauma and after neurosurgical
- •- Recent CVA
- •- Moyamoya disease
- •- General anesthesia planned for another procedure
研究者
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