Comparison of Efficacy of Dexmedetomidine and Melatonin for Sleep Induction for Electroencephalography in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Comparison of the three medical interventions on sleep initiation
研究概览
简要总结
The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG.
详细描述
At University Medical Centre Ljubljana (UMCL; Slovenia), the investigators use electroencephalography (EEG) in wakefulness and sleep for diagnostic and therapeutic purposes in children with (suspected) epilepsy. Since epileptiform activity can only be detected during sleep in some patients and because children with intellectual disabilities have sometimes problems with cooperation, EEG in induced sleep is required.
In this study, the investigators will enroll 150 children who need EEG recorded in their sleep. The investigators will compare safety and efficacy of the two active substances, one of which will be given in two possible routes. Fifty children will receive melatonin in the form of a syrup orally, 50 children will receive dexmedetomidine intranasally in the form of a nasal spray, and 50 children will receive dexmedetomidine sublingually. The investigators will monitor the following parameters: the time in which the child falls asleep, vital functions during sleep (blood pressure, blood oxygen saturation, respiratory rate frequency and heart rate frequency), the impact on the technical implementation of EEG, the depth of sleep and waking time. All parents will give their written consent for their child to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 and 20 years
- •Referral for EEG in sleep
- •Children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form
排除标准
- •Children that were unable to follow the study protocol were excluded during the study
研究组 & 干预措施
Melatonin peroral
0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring
干预措施: Electroencephalography (Diagnostic Test)
Melatonin peroral
0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring
干预措施: Monitoring of vital functions (Diagnostic Test)
Melatonin peroral
0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring
干预措施: Melatonin 0,1mg/kg oral syrup (Drug)
Dexmedetomidine intranasally
3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring
干预措施: Electroencephalography (Diagnostic Test)
Dexmedetomidine intranasally
3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring
干预措施: Monitoring of vital functions (Diagnostic Test)
Dexmedetomidine intranasally
3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring
干预措施: Dexmedetomidine 3 mcg/kg intranasally (Drug)
Dexmedetomidine sublingually
3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring
干预措施: Electroencephalography (Diagnostic Test)
Dexmedetomidine sublingually
3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring
干预措施: Monitoring of vital functions (Diagnostic Test)
Dexmedetomidine sublingually
3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring
干预措施: Dexmedetomidine 3 mcg/kg sublingually (Drug)
结局指标
主要结局
Comparison of the three medical interventions on sleep initiation
时间窗: During the intervention
The time-interval between the drug application and time of sleep initiation will be recorded in minutes. These values will be compared across the three arms of the study
Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG
时间窗: During the intervention
During EEG in sleep, which will be recorderd using a standard 10-20 placement with additional electrodes for breathing and ECG, the EEG background activity will be evaluated for the deepest sleep stage according to the standard EEG classification (Carskadon MA, Dement WC. Normal Human Sleep: an Overview. In: Kryger M, Roth T, Dement WC. Principles and practice of sleep medicine. St.Louis: Saunders/Elsevier, 2011:16-26.). Also, the sleep stage in which the patient will spend the most time will be noted. These values will be compared across the three arms of the study.
次要结局
- Comparison of the three medical interventions on respiratory rate(During the intervention)
- Comparison of the three medical interventions on heart rate(During the intervention)
- Comparison of the three medical interventions on oxygene saturation(During the intervention)
- Comparison of the three medical interventions on blood pressure(During the intervention)
研究者
Damjan Osredkar
Assoc. Prof. Damjan Osredkar, MD, PhD
University Medical Centre Ljubljana