A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children - a Double- Blind Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Satisfactory sedation
研究概览
简要总结
The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.
详细描述
Dexmedetomidine is a selective alpha-2 adrenoreceptor agonist that has sedative, anxiolytic and analgesic properties without causing respiratory depression. It has been administered safely and effectively via a number of routes including as an intravenous infusion, intramuscularly, intranasally, buccally and orally .
Yuen et al established that the median time of onset of sedation is 25-30 minutes, making it an ideal agent for preoperative sedation. The same group also studied doses of 1 mcg/kg and 2 mcg/kg as a sedative premedication and found that the success rates of appropriate sedation at induction in children aged 1 to 8 years were 53% and 66% respectively, with a dose related increase in successful sedation.
Much higher doses of dexmedetomidine have also been used safely. Administered intravenously, 3mcg/kg of dexmedetomidine has been shown to provide satisfactory sedation for paediatric MRI in 97% of cases, without adverse effects.
The investigators aim to show that high dose intranasal dexmedetomidine is a safe, effective and an easily administered sedative premedication.
The investigators hypothesise that 4mcg/kg compared to 2mcg/kg of intranasal dexmedetomidine will lead to at least a 20% increase in the proportion of satisfactorily sedated patients at the time of anaesthesia induction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children of American Society of Anesthesiologists (ASA) physical status classification I or II (healthy) between the ages of 6 months and 5 years undergoing surgery at Queen Mary Hospital
排除标准
- •Any patient receiving other sedative premedication, allergy to dexmedetomidine, organ dysfunction, cardiac arrhythmia and congenital heart disease.
研究组 & 干预措施
Dexmedetomidine 2 mcg/kg
2 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 4 mcg/kg
4 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Satisfactory sedation
时间窗: From 30 minutes post drug administration to induction of anaesthesia (average 30 minutes)
The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesic induction.
次要结局
- Blood pressure(From drug administration to end of anaesthesia (on average 1 to 3 hours))
- Heart rate(From drug administration to end of anaesthesia (on average 1 to 3 hours))
- Time to satisfactory sedation(From time of drug administration to when Observer's Assessment of Alertness/ Sedation Score is 2 or less (from 0 minutes to 30 minutes))
- Oxygen saturations(From drug administration to end of anaesthesia (on average 1 to 3 hours))