Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 14
- 主要终点
- Incidence of hypotension
研究概览
简要总结
The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section
详细描述
Intravenous fluid administration prior to spinal anesthesia for cesarean section is an established part of anesthetic practice for the prevention of maternal hypotension. Systematic reviews of clinical data suggest the usefulness of administering colloids to decrease the incidence of hypotension This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. Ringer's lactate solution in prevention of hypotension during spinal anesthesia for elective 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective cesarean section applying spinal anesthesia
- •≥ week 37 of gestation
- •Singleton pregnancy
排除标准
- •Suspicion of any hypertensive disease
- •Parturient in labor
研究组 & 干预措施
Group A
500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
干预措施: HES 130/0.4 (6%) in sodium chloride (solution for infusion) (Drug)
Group B
1000 mL Ringer's Lactate solution
干预措施: Ringer's Lactate solution (Drug)
结局指标
主要结局
Incidence of hypotension
时间窗: Time between induction of spinal anesthesia until delivery
次要结局
- Minimum of systolic blood pressure until delivery(between induction of anesthesia and delivery)
- Maternal heart rate between induction of anesthesia and delivery(between induction of anesthesia and delivery)
- Onset and duration of hypotension between induction of anesthesia and delivery(between induction of anesthesia and delivery)
- Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value(between induction of anesthesia and delivery)