The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The frequency of post-spinal hypotension
研究概览
简要总结
To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.
详细描述
Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.
Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.
Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.
The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women scheduled for cesarean section under spinal anesthesia
- •Gestational age of at least 37 weeks
排除标准
- •Patient refusal
- •Contraindications of spinal anesthesia
- •Allergy to the study drug
- •Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m
- •patients with cardiac morbidities
- •Hypertensive disorders of pregnancy.
- •Prepartum hemorrhage
研究组 & 干预措施
Norepinephrine (0.1)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.
干预措施: Norepinephrine (0.1) (Drug)
Norepinephrine (0.075)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.
干预措施: Norepinephrine (0.075) (Drug)
结局指标
主要结局
The frequency of post-spinal hypotension
时间窗: During the first hour after the subarachnoid block
次要结局
- Heart rate(During the first hour after the subarachnoid block)
- Arterial blood pressure (Systolic, diastolic, and mean)(During the first hour after the subarachnoid block)
- Doses of atropine and ephedrine(Intraoperative)
- Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score(1, 5, and 10 minutes after delivery)
研究者
Zakaria Ahmed Zakaria
Principal Investigator
Assiut University