The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Foetal heartrate
研究概览
简要总结
The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women
- •Over 18 years old
- •Undergoing elective caesarean section
- •Height over 160 cm or under 180 cm
排除标准
- •Allergic reactions to ephedrine or phenylephrine
- •High blood levels of bilirubin
- •HELPP syndrome
- •Preeclampsia (pregnancy-induced hypertension)
- •Non singleton pregnancies
研究组 & 干预措施
Ephedrine
干预措施: Ephedrine (Drug)
Phenylephrine
干预措施: Phenylephrine (Drug)
结局指标
主要结局
Foetal heartrate
时间窗: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
From before induction of spinal anaesthesia to 15 min after delivery
Frontal lobe cerebral oxygenation
时间窗: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.
次要结局
- Mean arterial pressure(Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)
- Umbilical cord pH and Base excess(Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.)
- Cardiac output(Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)
研究者
Visti Foss
Principal Investigator
Naestved Hospital