Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- incidence of bradycardia
研究概览
简要总结
This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section
详细描述
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally.
The aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. All parturients will also receive colloid co-hydration.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult parturients, American Society of Anesthesiologists (ASA) I-II,
- •singleton gestation>37 weeks
- •elective cesarean section
排除标准
- •Body Mass Index (BMI) >40 kg/m2
- •Body weight <50 kg
- •Body weight>100 kg
- •height<150 cm
- •height>180 cm
- •multiple gestation
- •fetal abnormality
- •fetal distress
- •active labor
- •cardiac disease
- •pregnancy-induced hypertension
- •thrombocytopenia
- •coagulation abnormalities
- •use of antihypertensive medication during pregnancy
- •communication or language barriers
- •lack of informed consent
- •contraindication for regional anesthesia
结局指标
主要结局
incidence of bradycardia
时间窗: intraoperative
any incidence of maternal bradycardia (heart rate\<60/min) will be recorded
incidence of hypotension
时间窗: intraoperative
any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded
次要结局
- neonatal blood gases(1 minute post delivery)
- incidence of hypertension(intraoperative)
- need for atropine(intraoperative)
- modification or cessation of the infusion(intraoperative)
- Neonatal Apgar score at 1 minutes(1 minute post delivery)
- need for vasoconstrictor(intraoperative)
- type of vasoconstrictor administered(intraoperative)
- total dose of vasoconstrictor administered(intraoperative)
- incidence of nausea/vomiting(intraoperative)
- number of bolus doses of vasoconstrictor administered(intraoperative)
- adrenaline in neonatal blood(5 minutes post delivery)
- glucose in neonatal blood(1 minute post delivery)
- noradrenaline in neonatal blood(5 minutes post delivery)
- Neonatal Apgar score at 5 minutes(5 minutes post delivery)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital