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临床试验/NCT00987701
NCT00987701已完成不适用

Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2009年9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
5,000
试验地点
1
主要终点
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

研究概览

简要总结

Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.

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
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • First time of delivery
  • ASA status I-II
  • No premature
  • No genetic and infectious diseases

排除标准

  • Subjects with cardiac and pulmonary disorders
  • Dislocation of placenta
  • Pregnant hypertension
  • Allergy to local anesthetics
  • Unwilling to cooperation
  • With significant delivery side effects

研究组 & 干预措施

Crystalloid resuscitation

Active Comparator

Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia

干预措施: Ringer's Lactate (Drug)

Colloid resuscitation

Active Comparator

Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia

干预措施: Six percent hydroxyethyl starch (Drug)

结局指标

主要结局

Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

时间窗: Immediate after birth (0 min)

次要结局

  • Apgar scoring(One min and 5min after birth.)
  • Umbilical-cord gases analysis(At the time baby was born (0min))
  • Neonatal sepsis evaluation(One hour after the baby was born)
  • Neonatal antibiotic treatment(One hour after the baby was born)
  • Incidence of maternal side effects(Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women))
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)(1month after birth)

研究者

发起方
Nanjing Medical University
申办方类型
Other

研究点 (1)

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