Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- postspinal hypotension
研究概览
简要总结
three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.
详细描述
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.
Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).
Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.
In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •full term
- •singleton
- •pregnant women
- •scheduled for elective cesarean delivery
排除标准
- •cardiac morbidities
- •hypertensive disorders of pregnancy
- •peripartum bleeding
- •baseline systolic blood pressure (SBP) < 100 mmHg
- •body mass index > 35 will be excluded from the study.
研究组 & 干预措施
0.025 mcg /Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min).
干预措施: norepinephrine infusion (0.025 mcg/Kg/min) (Drug)
0.025 mcg /Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min).
干预措施: Bupivacaine (Drug)
0.050 mcg/Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min).
干预措施: norepinephrine infusion (0.050 mcg/Kg/min) (Drug)
0.050 mcg/Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min).
干预措施: Bupivacaine (Drug)
0.075 mcg/Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min)
干预措施: norepinephrine infusion (0.075 mcg/Kg/min) (Drug)
0.075 mcg/Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min)
干预措施: Bupivacaine (Drug)
结局指标
主要结局
postspinal hypotension
时间窗: 30 minutes after spinal anesthesia
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
次要结局
- severe postspinal hypotension(30 minutes after spinal anesthesia)
- Atropine consumption(60 minutes after spinal block)
- intraoperative hypertension(60 minutes after spinal block)
- ephedrine consumption(60 minutes after spinal block)
- heart rate(60 minutes after spinal block)
- incidence of nausea and vomiting(60 minutes after spinal block)
- Post-delivery hypotension(10 minutes after delivery)
- systolic blood pressure(60 minutes after spinal block)
- diastolic blood pressure(60 minutes after spinal block)
- APGAR score(10 minutes after delivery)
研究者
Ahmed Hasanin
Assistant professor
Cairo University