Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Rate of hypotension
研究概览
简要总结
Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that epidural and spinal anesthesia during cesarean section possesses different responsiveness to fluid (including crystalloid and colloid) management given prior or posterior to anesthesia. Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown. The investigators hypothesized that fluid management during CSEA would produce different effect on hemodynamics in cesarean section compared with epidural and 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
- •Need intraoperative administration of vascular active agents
- •With significant delivery side effects
研究组 & 干预措施
Prior crystalloid
Crystalloid (Ringer's Lactate) was given before CSEA
干预措施: Ringer's Lactate (Drug)
Posterior crystalloid
Crystalloid (Ringer's Lactate) was given after CSEA
干预措施: Ringer's Lactate (Drug)
Prior colloid
Colloid (6% hydroxyethyl starch) was given before CSEA
干预措施: Six percent hydroxyethyl starch (Drug)
Posterior colloid
Colloid (6% hydroxyethyl starch) was given after CSEA
干预措施: Six percent hydroxyethyl starch (Drug)
结局指标
主要结局
Rate of hypotension
时间窗: Anesthesia begin (0 min) to 120 min after anesthesia
次要结局
- Recurrence of hypotension after ephedrine or phenylephrine(Anesthesia begin (0 min) to 120 min after anesthesia)
- Consumption of ephedrine and phenylephrine(Anesthesia begin (0 min) to 120 min after anesthesia)
- Total volume of colloid or crystalloid(Fifteen minutes before anesthesia to 120 min after anesthesia)
- One-min and 5-min Apgar scores(The first and fifth minute after cesarean successful delivery)
- Oxygen saturation during hypotension(Anesthesia begin (0 min) to 120 min after anesthesia)
- Duration of hypotension(Anesthesia begin (0 min) to 120 min after anesthesia)
- Low umbilical cord pH (artery < 7.20)(At the time of successful delivery (0 min))