Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- proportion of children attained satisfactory sedation
研究概览
简要总结
Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.
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
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-12 years old
- •American Society of Anesthesiologists (ASA) 1-2
- •Elective surgery
- •Children with autism or pervasive personality disorder
排除标准
- •American Society of Anaesthesiologists (ASA) 3-5
- •Allergy or hypersensitive reaction to dexmedetomidine
- •Known cardiac arrhythmia or congenital heart disease
- •Mentally disabled
研究组 & 干预措施
1mcg/kg
1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction
干预措施: Dexmedetomidine (Drug)
2mcg/kg
2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
proportion of children attained satisfactory sedation
时间窗: one hour
次要结局
- time to onset of sedation(one hour)
研究者
YUEN, Vivian Man-ying
Dr.
The University of Hong Kong