Prophylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section: A Multicenter, Single-blind, Crossover, Factorial Cluster Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- pH
研究概览
简要总结
This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.
详细描述
Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced 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 spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2*2 crossover and cluster randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 ≥37 weeks
- •American Society of Anesthesiologists physical status classification II
- •Scheduled for cesarean section under spinal anesthesia
排除标准
- •Body height < 150 cm
- •Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- •Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
- •Hemoglobin < 7g/dl
- •Fetal distress, or known fetal developmental anomaly
研究组 & 干预措施
Prophylactic norepinephrine group
A maintenance dose of norepinephrine (0.05 ug/kg/min) infusion simultaneous with spinal anesthesia. 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: Norepinephrine (Drug)
Rescue norepinephrine 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. Spinal anesthesia-induced hypotension is managed by administering a 6 μg intravenous bolus of norepinephrine.
干预措施: Norepinephrine (Drug)
Prophylactic phenylephrine group
A maintenance dose of phenylephrine (0.625 ug/kg/min) infusion simultaneous with spinal anesthesia. 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: Phenylephrine (Drug)
Rescue phenylephrine 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. Spinal anesthesia-induced hypotension is managed by administering a 75 μg intravenous bolus of phenylephrine.
干预措施: Phenylephrine (Drug)
结局指标
主要结局
pH
时间窗: Immediately after delivery
From umbilical arterial blood gases.
Base excess (BE)
时间窗: Immediately after delivery
From umbilical arterial blood gases.
次要结局
- Partial pressure of oxygen (PO2)(Immediately after delivery)
- The incidence of hypertension(1-15 minutes after spinal anesthesia)
- The incidence of nausea and vomiting(1-15 minutes after spinal anesthesia)
- The incidence of post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- The incidence of bradycardia(1-15 minutes after spinal anesthesia)
- The incidence of severe post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- APGAR score(5 min after delivery)
- APGAR score(1 min after delivery)
