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临床试验/NCT02146898
NCT02146898已完成不适用

The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
change in blood pressure

研究概览

简要总结

The investigators intend to study the impact of patient positioning on the changes in blood pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that the changes in blood pressure relate to the speed with which the spinal medication rises. By slowing the rise of spinal anesthesia, the investigators believe that the incidence and severity of hypotension might be reduced.

详细描述

Spinal anesthesia is the most commonly used anesthetic for cesarean delivery. In part, this is due to the ease of administration, reliability and low rates of adverse effects. Additionally, the avoidance of general anesthesia allows the parturient to participate in the birth experience, despite being in surgery.

Although hyperbaric local anesthetic solutions have a remarkable record of safety, their use is not totally without risk. The side effects of spinal anesthesia are well described, but most notably include hypotension (low blood pressure). Spinal hypotension is primarily due to the vasodilatory effects of local anesthetics, and would occur in virtually all women if not prevented or treated.

The incidence of hypotension in both the literature and in clinical practice ranges from 30% to 50% of all patients. Recent literature using a continuous, non-invasive blood pressure monitor suggests that hypotension occurs with greater frequency and may be associated with a higher incidence of adverse effects to either mother or fetus. The incidence and degree of hypotension have been associated with fetal acidosis, which is a sign of either poor perfusion of the placental bed, or increased metabolism due to the blood pressure medications.

The most effective treatment for spinal hypotension is uterine displacement using a hip wedge; the use of a hip wedge after spinal anesthesia is a standard of care. Other treatment, including fluid administration of either crystalloid or colloid, are either partially effective, clinical impractical, or result in administering large doses of medications that may have negative effects on the fetus.

Epidural anesthesia is associated with a reduction in the incidence and severity of hypotension compared with spinal anesthesia. This is believed to be due to the slower onset of sympathetic blockade with epidural anesthesia; this slow onset allows the physiologic compensation to changes in blood pressure. Unfortunately, the slower onset and lower reliability of epidural anesthesia prevents routine use in clinical practice for cesarean delivery.

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
Single (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

入选标准

  • Singleton pregnancy
  • Term gestation
  • Scheduled cesarean delivery
  • Spinal anesthesia for delivery

排除标准

  • Significant fetal concerns
  • Polyhydramnios
  • Macrosomia
  • Morbid obesity (BMI >40)
  • Chronic hypertension
  • Gestational hypertension
  • Preeclampsia
  • Type 1 diabetes
  • Contraindications to spinal anesthesia

结局指标

主要结局

change in blood pressure

时间窗: 20 minutes

percentage change in blood pressure after spinal anesthesia

次要结局

  • IV fluid administration(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Hess

Chief of Obstetric Anesthesia

Beth Israel Deaconess Medical Center

研究点 (2)

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