Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Elective Cesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.
研究概览
简要总结
The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.
详细描述
The purpose of this study is to determine the effective dose 90% (ED90) of metaraminol to treat hypotension after spinal anesthesia in elective cesarean sections (CS). It is a double-blind study that uses the biased-coin up-down sequential allocation method to determine the ED90 of metaraminol.
Baseline systolic blood pressure (SBP) will be determined by three automated measures 3 minutes apart just before CS. During the period from induction of spinal anesthesia to fetal delivery SBP will be monitored every minute and metaraminol will be administered every time it is lower than baseline value. If SBP falls below 80% of baseline value, the treatment will be considered a failure. An adequate response will be defined as the absence of hypotension during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective CS under spinal anesthesia
- •Normal singleton pregnancy beyond 36 weeks gestation
- •ASA physical status I/II
- •Age over 18 years
排除标准
- •Patient refusal
- •Allergy to metaraminol
- •Preexisting or pregnancy-induced hypertension
- •Cardiovascular or cerebrovascular disease
- •Fetal abnormalities
结局指标
主要结局
The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.
时间窗: From spinal induction until delivery (on average 30-60min)
Bolus doses of metaraminol will be used every time SBP falls below baseline values and maternal responses to doses will be used to build a dose response curve from where ED90 will be estimated.
次要结局
- Maternal Demographics (Age, Height, Weight and Gestational Age)
- Incidence of Nausea and Vomiting(From spinal induction until delivery (on average 30-60min))
- Time between skin incision and delivery
- Time between uterine incision and delivery
- Total dose of metaraminol
- Number of Participants with Hypertension or Bradycardia as a Measure of Safety and Tolerability(From spinal induction until delivery (on average 30-60min))
- Umbilical blood gases
- Fetal well-being with Apgar scores