Comparison of Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia During Cesarean Section: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Cardiac output (CO)
研究概览
简要总结
The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for 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. However, hemodynamic effects of the prophylactic norepinephrine infusion is still unknown. The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal 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
- Double (Participant, Care Provider)
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
Phenylephrine group
Phenylephrine infusion simultaneous with spinal anesthesia
干预措施: Phenylephrine (Drug)
Norepinephrine group
Norepinephrine infusion simultaneous with spinal anesthesia
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Cardiac output (CO)
时间窗: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system
Stroke volume (SV)
时间窗: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system
Systemic vascular resistance (SVR)
时间窗: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system
次要结局
- Overall stability of systolic blood pressure control versus baseline(1-30 minutes after spinal anesthesia)
- Overall stability of heart rate control versus baseline(1-30 minutes after spinal anesthesia)
- The incidence of post-spinal anesthesia hypotension(1-30 minutes after spinal anesthesia.)
- The incidence of severe post-spinal anesthesia hypotension.(1-30 minutes after spinal anesthesia.)
- The incidence of hypertension.(1-30 minutes after spinal anesthesia)
- The incidence of bradycardia.(1-30 minutes after spinal anesthesia)
- The incidence of nausea and vomiting.(1-30 minutes after spinal anesthesia)
- pH(Immediately after delivery)
- Partial pressure of oxygen (PO2)(Immediately after delivery)
- Base excess (BE)(Immediately after delivery)
- APGAR score(5 min after delivery)