Epinephrine Versus Phenylephrine Infusion for Prophylaxis Against Maternal Hypotension After Spinal Anesthesia for Cesarean Delivery: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- incidence of post spinal hypotension
研究概览
简要总结
Subarachnoid block is the common route of anesthesia for cesarean delivery. Maternal hypotension after subarachnoid block is very common despite the vigorous methods for its prevention. Maternal hypotension is sometimes deleterious to the mother and the fetus; thus, it is highly recommended to use prophylactic vasopressors directly after the block and before the blood pressure drops. The aim of this work is to compare the maternal and neonatal effects of epinephrine and phenylephrine when used as prophylactic infusion after subarachnoid block for cesarean delivery.
详细描述
Upon arrival to the operating room, routine monitoring will be applied (electrocardiography, pulse oximetry, and a non-invasive blood pressure monitor). Two 18G-cannula will be inserted, and 10 mg metoclopramide and 50 mg ranitidine will be delivered. Co-load infusion of lactated Ringer's solution will be infused at a rate of 15 mL/Kg over 10 minutes, and 10 mg hyperbaric bupivacaine in addition to 20 mcg fentanyl will be injected in the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in a supine position with left-lateral tilt and will receive the vasopressor infusion according to the allocated study group:
- Phenylephrine group (n=113): will receive phenylephrine infusion at rate of 0.4 mcg/Kg/min. (10 mg /1 mL) will be diluted to reach a final concentration of 10 mcg/mL(5).
- Epinephrine group (n=113): will receive epinephrine infusion dose of 0.03 mcg/Kg/min. epinephrine (1mg/ 1mL ampoule) will be diluted to reach a final concentration of 10 mcg/ml.
The prophylactic vasopressor infusion will be maintained until 5 minutes after delivery of the fetus
Hemodynamic management in both groups will be as follow:
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, admitted for elective cesarean delivery
- •aged between 18 and 40 years
排除标准
- •Patients with uncontrolled cardiac morbidities, hypertensive disorders of pregnancy
- •Peripartum bleeding
- •coagulation disorders
- •Baseline systolic blood pressure (SBP) < 100 mmHg
研究组 & 干预措施
phenylephrine
干预措施: Phenylephrine (Drug)
epinephrine
干预措施: Epinephrine (Drug)
结局指标
主要结局
incidence of post spinal hypotension
时间窗: from spinal anesthesia till delivery of fetus (about 45-60 mins)
systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus
次要结局
- incidence post spinal reactive hypertension(from spinal anesthesia till delivery of fetus (about 45-60 mins))
- fetal outcome(at birth)
研究者
Yasmin Hassab elnaby
assistant professor
Cairo University