Effectiveness of Intranasal Dexmedetomidine for Sedated Auditory Brainstem Response Testing
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- quality of diagnostic
研究概览
简要总结
Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.
This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.
Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.
The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization.
Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The possibility of an intranasal administration, avoids the pain and discomfort of a venous access insertion.
详细描述
Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.
This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.
Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.
The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization. An intranasal administration avoids the pain and discomfort of a venous access insertion.
Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The treatment will be administrated by intranasal way at a dosage of 2,5µg/ kg in a single administration under continuous cardiorespiratory monitoring for 2 hours..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 1 to 15 years old
- •American Society Anesthesiologists (ASA) scale patient 1 or 2
- •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
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 operation)
- •Recent cerebral vascular accident
- •Moyamoya disease
- •General anesthesia planned for another procedure
研究组 & 干预措施
Dexmedetomidine Hydrochloride
sedation of patients to perform auditory test
干预措施: Dexmedetomidine Hydrochloride (Drug)
结局指标
主要结局
quality of diagnostic
时间窗: 5 minutes after the realization of auditory test
measure the rate of children for who the auditory threshold is obtained with drug sedation condition.
次要结局
- tolerance of treatment(from drug administration to 24 hours after administration of drug)
- time of correct sedation(from 5 minutes after drug administration to 5 minutes before auditory test)
- time of vigilance recovery(from 5 minutes after auditory test to 5 minutes after the patient wake up (Aldrete score equal to 9))