Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- incidence of hypotension
研究概览
简要总结
Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients.
详细描述
Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. Ephedrine could be used to treat hypotension but lead to lower fetal pH, which may be related to worse fetal outcome.Norepinephrine could improve the hypotension to the same extent as phenylephrine. In this study, we tend to compare the effects of norepinephrine and ephedrine on hypotension in parturients and on fetal acid status.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective cesarean section
排除标准
- •Patients with severe pre-eclampsia
- •Patients with contraindications for spinal anesthesia
- •Patients with multiple pregnancy
- •Patients with gestation <38w
研究组 & 干预措施
norepinephrine
norepinephrine is injected after spinal anesthesia
干预措施: Norepinephrine (Drug)
ephedrine
ephedrine is injected after spinal anesthesia
干预措施: Ephedrine (Drug)
结局指标
主要结局
incidence of hypotension
时间窗: from immediately after spinal anesthesia to 30min after spinal anesthesia
次要结局
- pH value of fetal arterial blood(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
- lowest neonatal cerebral oxygen saturation(from clamp of the umbilical cord to 10 min later, 10min in total)
- lactate level of fetal arterial blood(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
- number of rescue vasoactive agent(from immediately after spinal anesthesia to 30min after spinal anesthesia)
- incidence of bradycardia(from immediately after spinal anesthesia to 30min after spinal anesthesia)
- incidence of dizzy(from immediately after spinal anesthesia to 30min after spinal anesthesia)
- fetal arterial partial pressure of oxygen(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
- arterial base excess of fetal arterial blood(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
- incidence of nausea and vomiting(from immediately after spinal anesthesia to 30min after spinal anesthesia)
- incidence of chest congestion(from immediately after spinal anesthesia to 30min after spinal anesthesia)
- incidence of dyspnea(from immediately after spinal anesthesia to 30min after spinal anesthesia)
- Apgar scores of the neonates(from clamp of umbilical cord to 5min after clamping)
研究者
Zhihong LU
Dr
Air Force Military Medical University, China