Effect of Prophylactic Intravenous Norepinephrine Infusion on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia for Caesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery.
研究概览
简要总结
Norepinephrine has emerged as a potential alternative for stabilizing blood pressure during spinal anesthesia for cesarean section, purportedly maintaining maternal heart rate and cardiac output more effectively than phenylephrine. However, its application as an intravenous bolus for treating hypotension remains underexplored. Consequently, this current investigation aimed to determine the ED50 and ED95 of norepinephrine for managing maternal hypotension during cesarean section. A prospective trial enrolled 100 patients undergoing elective delivery under spinal anesthesia, with norepinephrine dosage determined using the upper and lower sequential distribution method (UDM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria included women undergoing elective caesarean section undergoing combined lumbar and rigid anaesthesia, healthy singleton pregnancies at full term (more than 37 weeks gestation), American Society of Anaesthesiologists physical status I or II, body weight between 50-100 kg, height between 150-180 cm, and fasting for more than 8 hours.
排除标准
- •The exclusion criteria included individuals with hypertension, cardiovascular diseases, preeclampsia, arrhythmias, diabetes mellitus, spinal cord malformations, abnormal fetal conditions, and those who declined to participate in the study.
研究组 & 干预措施
Norepinephrine Bolus
Participants in this arm will receive norepinephrine as a bolus dose to treat maternal hypotension during cesarean section under spinal anesthesia. The dosage will be determined using the upper and lower sequential distribution method (UDM). The aim is to investigate the effective dose (ED50 and ED95) of norepinephrine in maintaining maternal blood pressure stability and optimizing maternal outcomes during the procedure.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery.
时间窗: From the initiation of anesthesia to the delivery of the fetus.
Intravenous norepinephrine pumped to maintain maternal systolic blood pressure 80% above its basal value prior to delivery of the foetus
次要结局
- Neonatal Apgar score(Immediately After delivery of the foetus)
- Intraoperative adverse reactions(Perioperative period)
- Number of remedial drugs(Perioperative period)
研究者
Chengfei Xu
doctor-in-charge
The Third People's Hospital of Bengbu