NCT01278238已完成不适用
Hemodynamic Effect of Prophylactic Phenylephrine Versus Lower Limb Compression in Women During Caesarean Section Under Spinal Anaesthesia
Anestesiavdelingen Baerum Sykehus1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Invasive arterial bloodpressure
研究概览
简要总结
The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.
The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.
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
- 是
入选标准
- •Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm
排除标准
- •Any form of disease or anomalities:
- •Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Phenylephrine
Active Comparator
干预措施: Phenylephrine (Drug)
Lower limb compression
Active Comparator
干预措施: Lower limb compression (Device)
结局指标
主要结局
Invasive arterial bloodpressure
时间窗: Until end of operation, up to roughly 1 hour
次要结局
- Cardiac Output(Until end of operation, roughly 1 hour)
- pH value from umbilical vessels of the newborn(straight after delivery)
- APGAR score of the newborn(1 + 5 + 10 minutes after delivery)
- Need for rescue pressor (ephedrine, phenylephrine)(Until end of operation, roughly 1 hour)
研究者
Jana Christine Kuhn
Dr.med.
Anestesiavdelingen Baerum Sykehus
研究点 (1)
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