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临床试验/NCT02245191
NCT02245191Unknown不适用

Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation in Patients With Preeclampsia Under Spinal Anesthesia for Cesarean

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年7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
入组人数
60
试验地点
1
主要终点
Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use

研究概览

简要总结

It is a prospective clinical trial with random distribution that intends to investigate maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean delivery in patients with pre-eclampsia.

详细描述

Spinal anesthesia has become the main anesthetic technique for cesarean delivery due to avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and promotion of early mother-neonate bonding. Spinal anesthesia should be safe and comfortable for mother and child when referring to the side effects, including hypotension. The choice of the best vasopressor in this context is approaching to a resolution, favoring phenylephrine use. However, studies on high-risk pregnancies are still required, such as uteroplacental insufficiency, preeclampsia and intra-uterine growth restriction cases. The purpose of this study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with preeclampsia under spinal anesthesia for cesarean delivery. Sixty pregnant patients will be recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol, making a total of three groups with 20 patients each. Variables to be analyzed are uterine arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean arterial blood pressure and maternal peripheral vascular resistance. These variables will be recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after vasopressor bolus. Averages will be calculated in these intervals and then compared to the alteration caused by spinal anesthesia and the return to basal levels after drug intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Preeclampsia patients
  • After 34 weeks pregnant

排除标准

  • Patients' refusal
  • Obstetric Emergency
  • Contraindications to spinal anesthesia

研究组 & 干预措施

Ephedrine Group

Experimental

Patients who will receive ephedrine after spinal anesthesia

干预措施: Ephedrine (Drug)

Phenylephrine Group

Experimental

Patients who will receive Phenylephrine after spinal anesthesia

干预措施: Phenylephrine (Drug)

Metaraminol

Experimental

Patients who will receive Metaraminol after spinal anesthesia

干预措施: Metaraminol (Drug)

结局指标

主要结局

Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use

时间窗: One year

Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia

时间窗: One year

Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.

时间窗: One year

Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.

时间窗: One year

The main purpose of this study is evaluate if one of related drugs (ephedrine, phenylephrine or metaraminol) is superior than others to keep the maternal cardiac output, uteroplacental and fetal cerebral bloodflow despite the hemodynamic changes that is peculiar after spinal anesthesia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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