6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ED 50 and ED 90
研究概览
简要总结
The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
详细描述
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension are still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-40 years
- •Primipara or multipara
- •Singleton pregnancy ≥ 37 weeks
- •American Society of Anesthesiologists physical status classification I to II
- •Scheduled for elective cesarean section under spinal anesthesia
排除标准
- •Body height < 150 cm
- •Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- •Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
- •Hemoglobin < 7g/dl
- •Coagulation or renal function disorders
- •Known allergy to hydroxyethyl starch
- •Fetal distress, or known fetal developmental anomaly
研究组 & 干预措施
Hydroxyethyl starch (130/0.4) coload group
An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia.
干预措施: Hydroxyethyl starch 130/0.4 (Drug)
结局指标
主要结局
ED 50 and ED 90
时间窗: 1-15 minutes after spinal anesthesia
The dose of 6% Hydroxyethyl starch (130/0.4) that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
次要结局
- The incidence of hypertension.(1-15 minutes after spinal anesthesia)
- The incidence of post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia)
- pH(Immediately after delivery)
- The incidence of severe post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia)
- Partial pressure of oxygen (PO2)(Immediately after delivery)
- Base excess (BE)(Immediately after delivery)
- APGAR score(5 min after delivery)