Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- Incidence of post spinal hypotension
研究概览
简要总结
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration.
The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
详细描述
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia.
The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in 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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia
- •AGE>15 years
- •ASA II status
- •No history of hypertension, preeclampsia or cardiopathy
排除标准
- •cesarean section under genearl anesthesia or epidural analgesia during labor
研究组 & 干预措施
norepinephrin group
The patients of this group will recieve 0.5 micro gr/kg of norepinephin intravenously, the infusion will start during the intrathecal injection and during 10 minutes
干预措施: Norepinephrine (Drug)
Ephedrin group
The patients of this group will recieve 0,3mg/kg of Ephedrin intravenously, the infusion will start during the intrathecal injection and during 10 minutes
干预措施: Ephedrine (Drug)
结局指标
主要结局
Incidence of post spinal hypotension
时间窗: during the first 20 minutes after spinal anesthesia
decrease of systolic arterial blood pressure \> 20% baseline
次要结局
- Lowest systolic blood pressure(uring the first 20 minutes after spinal anesthesia)
- Incidence of bradycardia(during the first 20 minutes after spinal anesthesia)
- incidence of nausea and/or vomiting(during the first 20 minutes after spinal anesthesia)
- Apgar score(20min after spinal anesthesia)
- fetal ph(20min after spinal anesthesia)
- fetal blood lactates(20min after spinal anesthesia)
研究者
Mhamed Sami Mebazaa
Head of the anesthesia intensive care department
Mongi Slim Hospital