The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 主要终点
- percentage of time at target sedation score
研究概览
简要总结
To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent；
- •pediatric patients admitted to intensive care unit after general anesthesia;
- •expected mechanical ventilation time >6 hours; （4）1 months to 16 years old; -
排除标准
- •congenital heart disease, arrhythmias and heart failure;
- •Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
- •Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
- •central nervous system disease;
- •spinal analgesia or muscle relaxants is used during PICU;
- •the drug that affects the nerve conduction is used in one month;
- •allergy to the test drug or having other contraindications;
- •participated in other studies 30 days prior to admission of PICU; -
研究组 & 干预措施
Midazolam
midazolam 3～5μg/kg•min for maintenance of sedation.
干预措施: Midazolam (Drug)
Midazolam
midazolam 3～5μg/kg•min for maintenance of sedation.
干预措施: Fentanyl (Drug)
Midazolam
midazolam 3～5μg/kg•min for maintenance of sedation.
干预措施: assessment (Other)
Dexmedetomidine1
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine1
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: Fentanyl (Drug)
Dexmedetomidine1
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: assessment (Other)
Dexmedetomidine2
Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine2
Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: Fentanyl (Drug)
Dexmedetomidine2
Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: assessment (Other)
Dexmedetomiding3
Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: Dexmedetomidine (Drug)
Dexmedetomiding3
Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: Fentanyl (Drug)
Dexmedetomiding3
Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
干预措施: assessment (Other)
结局指标
主要结局
percentage of time at target sedation score
时间窗: up to 24 hours
assess the sedation level every 2 min using Ramsay score
the number of patients requiring the sedation remedy
时间窗: up to 24 hours
the number of patients requiring the sedation remedy during the mechanical ventilation
the dosage of midazolam that need for the sedation remedy
时间窗: up to 24 hours
the dosage of midazolam that need for sedation remedy during the mechanical ventilation
次要结局
- the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used(up to 24 hours)
- change of blood oxygen saturation(up to 24 hours)
- change of respiratory rate(up to 24 hours)
- extubation time(up to 24 hours)
- the dosage of sedation and analgesia drug(up to 24 hours)
- change of blood pressure(up to 24 hours.)
- change of heart rate(up to 24 hours)
- change of hepatic function(up to 24 hours)
- the dosage of fentanyl in and after 6 hours from study drug used(up to 24 hours)
- change of renal function(up to 24 hours)
研究者
Yuanyuan Xu
Anesthesia Department
Anhui Provincial Children's Hospital