NCT00926705已完成3 期
An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Intraoperative and postoperative fentanyl requirement (in microg/kg)
研究概览
简要总结
The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-12 years undergoing hypospadias repair
排除标准
- •Allergy to Dexmedetomidine
- •Preoperative use of sedatives or analgesics
- •cardiac diseases
- •Children with mental retardation
研究组 & 干预措施
Fentanyl
Active Comparator
This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
干预措施: Fentanyl (Drug)
Dexmedetomidine and Fentanyl
Experimental
This group received a combination of Dexmedetomidine (1 ug/kg) and Fentanyl (1.79 ug/kg). Total number of patients in this group 24.
干预措施: Dexmedetomidine and Fentanyl (Drug)
结局指标
主要结局
Intraoperative and postoperative fentanyl requirement (in microg/kg)
时间窗: 6/2008-1/2009
次要结局
未报告次要终点
研究者
研究点 (1)
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