Comparison of the Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension in Patients With Severe Preeclampsia During Caesarean Section
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
研究概览
简要总结
The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.
详细描述
Preeclampsia, which affects 5% to 7% of patients, 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 patients with preeclampsia are apparently higher than healthy patients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in patients with preeclampsia for cesarean section. In preeclampsia patients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% patients 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 patients undergoing cesarean section. However, the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus is still unknown. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean 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
Prophylactic phenylephrine bolus simultaneous with spinal anesthesia
干预措施: Phenylephrine (Drug)
Norepinephrine group
Prophylactic norepinephrine bolus simultaneous with spinal anesthesia
干预措施: Norepinephrine (Drug)
结局指标
主要结局
The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
时间窗: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) \< 80% of the baseline
次要结局
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia)
- The incidence of hypertension.(1-15 minutes after spinal anesthesia)
- pH(Immediately after delivery)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia)
- Base excess (BE)(Immediately after delivery)
- APGAR score(5 min after delivery)
- The incidence of severe post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia)
- The incidence of post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- Partial pressure of oxygen (PO2)(Immediately after delivery)