Comparison of Different 6% Hydroxyethyl Starch (130/0.4) Coload Volumes on the 90% Effective Dose of Norepinephrine Infusion Prophylaxis for Hypotension During Spinal Anesthesia for Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- ED 50
研究概览
简要总结
The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for 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. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years
- •Primipara or multipara
- •Singleton pregnancy ≥37 weeks
- •American Society of Anesthesiologists physical status classification I to II
- •Scheduled for 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 ≥180 mmHg
- •Hemoglobin < 7g/dl
- •Fetal distress, or known fetal developmental anomaly
研究组 & 干预措施
0 ml/kg Hydroxyethyl starch coload group
No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia
干预措施: Hydroxyethyl starch coload - 0 ml/kg (Drug)
5 ml/kg Hydroxyethyl starch coload group
5 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
干预措施: Hydroxyethyl starch coload - 5 ml/kg (Drug)
10 ml/kg Hydroxyethyl starch coload group
10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
干预措施: Hydroxyethyl starch coload - 10 ml/kg (Drug)
结局指标
主要结局
ED 50
时间窗: 1-15 minutes after spinal anesthesia
The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) of patients
ED 90
时间窗: 1-15 minutes after spinal anesthesia
The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 90% (ED90) of patients
次要结局
- The incidence of post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- The incidence of severe post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- The incidence of bradycardia(1-15 minutes after spinal anesthesia)
- The incidence of nausea and vomiting(1-15 minutes after spinal anesthesia)
- The incidence of hypertension(1-15 minutes after spinal anesthesia)
- pH(Immediately after delivery)
- Partial pressure of oxygen (PO2)(Immediately after delivery)
- Base excess (BE)(Immediately after delivery)
- APGAR score(5 min after delivery)