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临床试验/NCT01835873
NCT01835873已完成不适用

Comparative Study of the Effect of 6% Hydroxyethyl Starch 130/0.42 vs Lactated Ringer's Preload on the Hemodynamic Status of Parturients Undergoing Spinal Anesthesia for Elective Cesarean Delivery. Arterial Pulse Contour Analysis (FloTrac/VigileoTM) is Employed for Continuous Monitoring of Maternal Hemodynamic Parameters

Paraskevi Matsota2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Incidence of spinal anesthesia induced hypotension in elective cesarean deliveries preloaded with either crystalloid or colloid solution.

研究概览

简要总结

Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia obstetric deliveries because of the ability to use fewer drugs, a more direct experience of childbirth and the capability to provide excellent postoperative analgesia. However, the incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead to maternal and fetal morbidities. Certain interventions may reduce the incidence and severity of spinal anesthesia induced hypotension, including the use of vasopressors and intravenous pre- or co-hydration using different types of volume expanders; crystalloid or colloid solutions. Such interventions aim to increase maternal cardiac output, which is the key in attenuating the hypotensive response to spinal anesthesia.

The primary purpose of this study is to compare the efficacy of intravenous prehydration (preloading) of healthy parturients scheduled for caesarean section with either a crystalloid (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of hypotension after spinal anesthesia.

The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by employment of a minimally invasive technique based on arterial pulse contour analysis. Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a secondary outcome. Other secondary outcomes are total amount of vasopressors used, neonatal outcome, intraoperative side effects and maternal satisfaction scores.

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 (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) I and II parturients
  • singleton gestation
  • term gestation (gestational period more than 37 weeks)

排除标准

  • extremes of weight (<50 Kgr or >120 Kgr)
  • extremes of height (<150 cm or >180 cm)
  • baseline heart rate less than 65 bpm
  • active labor
  • known fetal abnormalities
  • placental abruption, placenta previa/accreta
  • pregnancy induced hypertension
  • anemia (hemoglobin < 9 gr/dl)
  • cardiac, respiratory or renal disease
  • diabetes mellitus
  • spinal cord abnormalities
  • previous spinal surgery
  • preexisting neurological dysfunction
  • known allergy to any protocol medication
  • any absolute contraindication to regional anesthesia

研究组 & 干预措施

Lactated Ringer's

Active Comparator

Crystalloid solution - 1000 ml preload

干预措施: Lactated Ringer's (Other)

HES 130/0.42

Active Comparator

Hydroxyethyl starch (HES 130/0.42) - 500 ml preload

干预措施: HES 130/0.42 (Other)

结局指标

主要结局

Incidence of spinal anesthesia induced hypotension in elective cesarean deliveries preloaded with either crystalloid or colloid solution.

时间窗: Maternal hemodynamic data is assessed before volume preload, immediately after volume preload, immediately after spinal anesthesia and at one minute intervals thereafter until placental delivery. Expected average of 40 minutes.

次要结局

未报告次要终点

研究者

发起方
Paraskevi Matsota
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paraskevi Matsota

Assistant Professor of Anesthesiology, MD, PhD

Attikon Hospital

研究点 (2)

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