Effect of Three Weight-adjusted Vasopressors for With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Umbilical artery blood pH
研究概览
简要总结
This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.
详细描述
At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. We compare the effects of three drugs on the fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .
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
- 是
入选标准
- •Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
- •height 150-180 cm;
- •American Society of Anesthesiologists (ASA) physical status II-III;
- •body mass index (BMI) <35 kg/m2.
排除标准
- •transverse presentation, fetal macrosomia;
- •uterine abnormalities (eg, large fibroids, bicornuate uterus);
- •polyhydramnios;
- •ruptured membranes, oligohydramnios;
- •intrauterine growth restriction;
- •gestational or nongestational hypertension, diabetes, or eclampsia;
- •hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for >10 years) or renal failure;
- •contraindications for combined spinal-epidural anesthesia;
- •participants who declined to sign informed consent forms.
研究组 & 干预措施
metaraminol group
During the cesarean section, metaraminol 2ug/kg/min is preventively infused after anesthesia to prevent and treat hypotension.
干预措施: metaraminol (Drug)
phenylephrine group
During cesarean section, preventive infusion of phenylephrine 0.54ug/kg/min after anesthesia to prevent and treat hypotension.
干预措施: Phenylephrine (Drug)
norepinephrine group
During cesarean section, preventive infusion of norepinephrine 0.08ug/kg/min after anesthesia to prevent and treat hypotension.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Umbilical artery blood pH
时间窗: 30 seconds after delivery
pH value of fetal umbilical artery blood
次要结局
- Umbilical artery blood base excess(30sec after delivery)
- The incidence of vomiting in pregnant women(Intraoperative)
- bradycardia(Intraoperative)
- hypotension(Intraoperative)
- The incidence of nausea in pregnant women(Intraoperative)
研究者
Chao Xu
Head of Otolaryngology
Xuzhou Medical University