Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- pharmacokinitics of dexmedetomidine
研究概览
简要总结
the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.
详细描述
Inhalation of nebulized drug is an alternative route of administration that is relatively easy to set up, does not require venpuncture, but is associated with high bioavailability of the administered drug. Information on the pharmacokinetics of dexmedetomidine in the pediatric population is very limited, especially in children. To the best of investigators knowledge, there are no published reports on the pharmacokinetics of nebulized dexmedetomidine in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child aged 2-7 years
- •ASA I or II
- •scheduled for abdominal surgery
- •with average weight, height, normal serum albumin
排除标准
- •patients with allergy to the study drug
- •patients with significant organ dysfunction
- •patients with cardiac arrhythmia
- •patients with congenital heart disease
- •use of psychotropic medication and mental retardation.
研究组 & 干预措施
nebulized dexmedetomidine 2ug/kg
inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
干预措施: nebulized Dexmedetomidine (Drug)
nebulized dexmedetomidine 3ug/kg
inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization
干预措施: nebulized Dexmedetomidine (Drug)
结局指标
主要结局
pharmacokinitics of dexmedetomidine
时间窗: at the basline and after the end of nebuization of the drug at 5 minutes,15 minutes,30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes
serum level of dexmedetomidine
次要结局
- sedation score(baseline and after end of the drug adminstration by 30 mininute)
研究者
Shereen Mamdouh
lecturer of anesthesia, ICU and pain manegement
Assiut University