Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes in Preeclamptic Patients During Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- pH
研究概览
简要总结
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following 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 impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following 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
- Single (Participant)
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
Standard group
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
干预措施: Alpha-Agonist (Drug)
Intensive 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: α-adrenergic receptor agonist (Drug)
结局指标
主要结局
pH
时间窗: Immediately after delivery
From umbilical arterial blood gases.
Base excess
时间窗: Immediately after delivery
From umbilical arterial blood gases.
次要结局
- 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 hypertension.(1-15 minutes after spinal anesthesia.)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia.)
- APGAR score(5 min after delivery)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia.)
- Partial pressure of oxygen (PO2)(Immediately after delivery)