Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Rate of hypotension
研究概览
简要总结
Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.
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
- Triple (Participant, Care Provider, 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
- 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
- •With contradictions of neuraxial anesthesia
研究组 & 干预措施
Epidural crystalloid
Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section
干预措施: Ringer's Lactate (Drug)
Epidural colloid
Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section
干预措施: Six percent hydroxyethyl starch (Drug)
Spinal crystalloid
Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section
干预措施: Ringer's Lactate (Drug)
Spinal colloid
Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section
干预措施: Six percent hydroxyethyl starch (Drug)
CSEA crystalloid
Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section
干预措施: Ringer's Lactate (Drug)
CSEA colloid
Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section
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
- Consumption of ephedrine and phenylephrine(Anesthesia begin (0 min) to 120 min after anesthesia)
- Duration of hypotension(Anesthesia begin (0 min) to 120 min after anesthesia)
- Oxygen saturation during hypotension(Anesthesia begin (0 min) to 120 min after anesthesia)
- Recurrence of hypotension after ephedrine or phenylephrine(Anesthesia begin (0 min) to 120 min after anesthesia)
- One-min and 5-min Apgar scores(The first and fifth minute after cesarean successful delivery)
- Low umbilical cord pH (artery < 7.20)(At the time of successful delivery (0 min))