Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.
研究概览
简要总结
Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a very common problem leading to several complications to both patients and their babies. It can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important complication is the decreasing blood flow to babies; which may lead to fetal acidosis.
Many interventions has been studied in order to prevent hypotension after spinal anesthesia in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine, phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic drug) can be effectively used to prevent hypotension after spinal anesthesia in normal patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish reflex.
This aim of this study is to compare the efficacy of ephedrine and ondansetron in the prevention of maternal hypotension after spinal anesthesia in cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Elective cesarean section
- •Patient accept spinal anesthesia
- •ASA classification I-II
- •Term, Singleton pregnancy
- •Understand all process in this study
排除标准
- •DM any type that not the gestational DM
- •Hypertensive disorder
- •Complicated pregnancy such as placenta previa, preeclampsia
- •Allergic to study drugs
- •Long QT syndrome
- •Contraindication to spinal anesthesia
研究组 & 干预措施
Group P
Normal saline 10 ml
干预措施: Placebo (Drug)
Group E
Ephedrine 10 mg in Normal Saline 10 ml
干预措施: Ephedrine (Drug)
Group O
Ondansetron 8 mg in Normal saline 10 ml
干预措施: Ondansetron (Drug)
结局指标
主要结局
Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.
时间窗: After spinal block to until baby delivered
Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery.
次要结局
- Maternal symptom: Nausea and vomiting after spinal anesthesia(After spinal anesthesia until baby delivered)