Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 95
- 主要终点
- The incidence of post-spinal anesthesia hypotension
研究概览
简要总结
The purpose of this study is to investigate the suitable infusion dose of phenylephrine 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. Practical guidelines for obstetric anesthesia from the American Society of Anesthesiologists and an international consensus statement on the management of hypotension with vasopressors indicate either IV ephedrine or phenylephrine may be used to correct hypotension. But the suitable infusion dose of phenylephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of phenylephrine 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
0.625 μg/kg/min group
A maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block
干预措施: Phenylephrine (Drug)
Control group
Normal saline infusion simultaneous with subarachnoid block
干预措施: Normal saline (Drug)
0.3125 μg/kg/min group
A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block
干预措施: Phenylephrine (Drug)
0.9375 μg/kg/min group
A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block
干预措施: Phenylephrine (Drug)
结局指标
主要结局
The incidence of post-spinal anesthesia hypotension
时间窗: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) \< 80% of the baseline
次要结局
- Overall stability of heart rate control versus baseline(1-15 minutes after spinal anesthesia)
- APGAR score(5 min after delivery)
- The incidence of hypertension.(1-15 minutes after spinal anesthesia)
- pH(Immediately after delivery)
- Partial pressure of oxygen(Immediately after delivery)
- Base excess(Immediately after delivery)
- Overall stability of systolic blood pressure control versus baseline(1-15 minutes after spinal anesthesia)
- The incidence of severe post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- The incidence of nausea and vomiting(1-15 minutes after spinal anesthesia)
- The incidence of bradycardia(1-15 minutes after spinal anesthesia)