Cardiovascular Effects of Carbetocin During Elective Caesarean Delivery: A Randomized Controlled Trial Comparing Infusion Versus Bolus Administration Using Nexfin™
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- percent change in cardiac output parameters as measured by non-invasive cardiac output monitor
研究概览
简要总结
The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.
详细描述
Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •elective cesarean delivery under spinal,
- •low risk for post partum hemorrhage,
- •able to understand english
排除标准
- •cesarean under general anesthesia,
- •bleeding condition,
- •placenta previa,
- •unable to understand english
研究组 & 干预措施
Infusion
carbetocin is given slowly
干预措施: carbetocin (Drug)
Bolus
carbetocin is given quickly
干预措施: carbetocin (Drug)
结局指标
主要结局
percent change in cardiac output parameters as measured by non-invasive cardiac output monitor
时间窗: 10 minutes
the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period
次要结局
- incidence of side effects occurring within timeframe below(30 minutes)