Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The incidence of bradycardia
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
详细描述
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the efficacy and safety in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing 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
- Triple (Participant, Care Provider, Outcomes Assessor)
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 ≥32 weeks
- •American Society of Anesthesiologists physical status classification II to III
- •Scheduled for cesarean section under spinal anesthesia
排除标准
- •Baseline blood pressure ≥180 mmHg
- •Body height < 150 cm
- •Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- •Eclampsia or chronic hypertension
- •Hemoglobin < 7g/dl
- •Fetal distress, or known fetal developmental anomaly
研究组 & 干预措施
Control group
Phenylephrine infusion simultaneous with subarachnoid block
干预措施: Phenylephrine (Drug)
Norepinephrine group
Norepinephrine infusion simultaneous with subarachnoid block
干预措施: Norepinephrine (Drug)
结局指标
主要结局
The incidence of bradycardia
时间窗: 1-15 minutes after spinal anesthesia.
Heart rate \< 60 beats/min
次要结局
- Overall stability of systolic blood pressure control versus baseline(1-15 minutes after spinal anesthesia)
