Effect of 90% Effective Dose of Metaraminol in Supine and Left Tilt Positions on Cesarean Section：A Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Umbilical artery blood pH
研究概览
简要总结
For hypotension after spinal anesthesia, metaraminol has different 90% effective doses in the supine position and the left-tilt position. We plan to conduct a non-inferiority trial to compare the effects of the two on the fetus and the mother.
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
- None
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
- •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
left-tilt group
After spinal anesthesia, the patient was placed in a 15° left position until the fetus was delivered, and metaraminol was given at an initial rate of 2.00μg/kg/min throughout the process.
干预措施: Metaraminol 2μg/kg/min (Drug)
supine group
After spinal anesthesia, the patient was placed in a supine position until the fetus was delivered, and metaraminol was given at an initial rate of 2.7μg/kg/min throughout the process.
干预措施: Metaraminol 2.7μg/kg/min (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
- hypotension(Intraoperative)
- bradycardia(Intraoperative)
- The incidence of vomiting in pregnant women(Intraoperative)
- Umbilical artery blood base excess(30sec after delivery)
- The incidence of nausea in pregnant women(Intraoperative)
研究者
Yi Feng, MD
Head of Anesthesiology
Peking University People's Hospital