NCT01075490Unknown4 期
Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- number of "rescue" general anesthesia
研究概览
简要总结
This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.
详细描述
Ex premies and term neonates are two subgroups investigated separately. The overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid "rescue" general anesthesia that occur in 20-40 % of patients with plain bupivacaine.
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
- — 至 60 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns less than 60 weeks old post-conceptional, former premature or not
- •Newborns requiring inguinal hernia or lower limbs surgery,
- •infants needing no more critical care assistance
- •Informed consent of parents
排除标准
- •Spinal malformation,
- •Coagulopathy,
- •critical hemodynamics,
- •uncontrolled neurologic or metabolic pathology.
- •infection at injection point.
研究组 & 干预措施
prematurely born, bupivacaine, placebo
Placebo Comparator
干预措施: clonidine (Drug)
prematurely born, bupivacaine, clonidine
Experimental
干预措施: clonidine (Drug)
term neonate, bupivacaine, placebo
Placebo Comparator
干预措施: clonidine (Drug)
term neonate, bupivacaine, clonidine
Experimental
干预措施: clonidine (Drug)
结局指标
主要结局
number of "rescue" general anesthesia
时间窗: end of surgery
次要结局
- duration of spinal anesthesia(during 24h)
- apnea and desaturation occurrence(during 24h)
研究者
研究点 (1)
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