The Safety、Efficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric
试验速览
- 阶段
- 4 期
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine
研究概览
简要总结
- Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric.
- Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric.
- Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in Pediatric.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •selective operation of inguinal hernia repair、orthopedics operation or general surgery operation in children
- •aged 3-9 years
- •ASA I - II
- •enter the operating room by himself without parents
- •normal liver and kidney function
- •no history of anesthesia medication allergy.
排除标准
- •allergic to dexmedetomidine, similar active ingredients or excipients
- •G-6-PD deficiency
- •a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on
- •a history of use of alpha 2 receptor agonists or antagonists.
研究组 & 干预措施
group 1.1
Normal saline group
干预措施: Dexmedetomidine (Drug)
group 1.2
0.25μg/kg dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
group 1.3
0.5μg/kg dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
group 1.4
0.75μg/kg dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
group 1.5
1.0μg/kg dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine
时间窗: up to 4 months
Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric
Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric
时间窗: up to 6 months
After a single Rapid Intravenous dose of Dexmedetomidine in Pediatric，blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).
Pharmacokinetics of Dexmedetomidine administered as a nasal spray
时间窗: up to 6 months
After a single dose of Dexmedetomidine administered as a nasal spray in Pediatric,blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).
次要结局
未报告次要终点