NCT02025426终止4 期
Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Cerebral Tissue Oxygen Saturation
研究概览
简要总结
Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Age ≥18 yrs
- •Pre-eclampsia (mild, or severe)
- •Non-laboring women
- •CD under spinal anesthesia
排除标准
- •Height < 5'0"
- •Allergy to phenylephrine or ephedrine, or any other standardized medication
- •Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III and IV)
- •Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- •History of recent amphetamine or cocaine use.
- •Subject enrollment in another study involving a study medication within 30 days of CD
- •Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
研究组 & 干预措施
Phenylephrine
Active Comparator
Phenylephrine for maintaining blood pressure within 10 % of baseline
干预措施: Phenylephrine (Drug)
Ephedrine
Active Comparator
Ephedrine for maintaining blood pressure within 10 % of baseline
干预措施: Ephedrine (Drug)
结局指标
主要结局
Cerebral Tissue Oxygen Saturation
时间窗: Intraoperative from spinal placement till 10 min after delivery
次要结局
- Cardiac Output(Intraoperative from spinal placement till 10 min after delivery)
研究者
研究点 (1)
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