ED90 of Norepinephrine and Phenylephrine Boluses for Treating Postspinal Anesthesia Hypotension Under Intensive Treatment in Preeclamptic Patients During Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- ED50 and ED90
研究概览
简要总结
The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section
详细描述
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during 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 I to III
- •Scheduled for cesarean section under spinal anesthesia
排除标准
- •Baseline blood pressure ≥160 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
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
干预措施: Phenylephrine (Drug)
Norepinephrine group
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
ED50 and ED90
时间窗: 1-15 minutes after spinal anesthesia
The doses of prophylactic norepinephrine and phenylephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
次要结局
- Partial pressure of oxygen (PO2)(Immediately after delivery)
- APGAR score(5 min after delivery)
- The incidence of hypertension.(1-15 minutes after spinal anesthesia)
- pH(Immediately after delivery)
- Base excess(Immediately after delivery)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia)
- The incidence of post-spinal anesthesia hypotension(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)