Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics 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
- 160
- 主要终点
- Cardiac index
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 maternal hemodynamics 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 maternal hemodynamics 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
Cardiac index
时间窗: 1-15 minutes after spinal anesthesia.
Monitoring data
Cardiac output
时间窗: 1-15 minutes after spinal anesthesia.
Monitoring data
Stroke volume variation
时间窗: 1-15 minutes after spinal anesthesia.
Monitoring data
Peripheral vascular resistance
时间窗: 1-15 minutes after spinal anesthesia.
Monitoring data
次要结局
- The incidence of hypertension.(1-15 minutes after spinal anesthesia.)
- pH(Immediately after delivery)
- Base excess(Immediately after delivery)
- Partial pressure of oxygen (PO2)(Immediately after delivery)
- APGAR score(5 min after delivery)
- 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 bradycardia.(1-15 minutes after spinal anesthesia.)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia.)