Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of hypotensive episodes.
研究概览
简要总结
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.
详细描述
Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.
排除标准
- •Patient refusal either to study enrollment or to spinal anesthesia.
- •Any absolute contraindication to spinal anesthesia e.g. coagulopathy, skin infection at site of injection.
- •Allergy to any of study drugs.
- •Patients with cardiac morbidities, hypertensive disorders or peripartum bleeding
- •BMI > 40 kg/m²
- •Baseline systolic blood pressure < 100 mmHg.
研究组 & 干预措施
NEP group
Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline.
干预措施: Norepinephrine (Drug)
PHE group
Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate.
干预措施: Phenylephrine (Drug)
结局指标
主要结局
Incidence of hypotensive episodes.
时间窗: 15-20 minutes
Hypotension is defined as \<80% of baseline or systolic blood pressure (SBP) \<100 mmHg.
次要结局
- Incidence of maternal bradycardia.(15-20 minutes)
- Incidence of reactive hypertension(20 minutes)
- nausea and vomiting(20 minutes)
- Total dose of vasopressor(20 minutes)
研究者
Shimaa Abbas Hassan
Principal Investigator
Assiut University