NCT00685672已完成4 期
Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Plasma concentration of fentanyl
研究概览
简要总结
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth
详细描述
Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet University Hospital, may be included. A randomized, placebocontrolled, double blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of pain relief, total amount of epidural solution injected, and plasma concentration of fentanyl.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at term in active labor
排除标准
- •age below 18 years
- •BMI > 40
- •drug hypersensitivity
研究组 & 干预措施
1
Experimental
adrenalin
干预措施: adrenalin (Drug)
2
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Plasma concentration of fentanyl
时间窗: hours
次要结局
- length of active labor(hours)
研究者
Leiv Arne Rosseland
Professor
Oslo University Hospital
研究点 (2)
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