Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 主要终点
- Hypotension
研究概览
简要总结
Hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (CNAP, CNSystems, Austria).
详细描述
Hypotension occurs commonly during spinal anesthesia for cesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure (CNAP, CNSystems, Austria) monitoring feeding hemodynamic data to a laptop computer, which triggers syringe pumps to deliver phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure fell to below 90% of baseline.
A randomised controlled trial was done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) was given every 60 seconds by the attending anesthesiologist when systolic blood pressure was below 90% of baseline as measured by conventional intermittent non-invasive blood pressure monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 21-45 years old,
- •weight 40-90 kg,
- •height 145-170 cm
排除标准
- •contraindications to spinal anaesthesia,
- •allergy to drugs used in the study, and
- •those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease
研究组 & 干预措施
vasopressor delivery automated system
vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
干预措施: Vasopressor automated delivery system (Device)
manual vasopressor delivery
manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
干预措施: Manual vasopressor delivery system (Device)
vasopressor delivery automated system
vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
干预措施: Phenylephrine (Drug)
manual vasopressor delivery
manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
干预措施: Phenylephrine (Drug)
vasopressor delivery automated system
vasopressor delivery automated system that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
干预措施: Ephedrine (Drug)
manual vasopressor delivery
manual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
干预措施: Ephedrine (Drug)
结局指标
主要结局
Hypotension
时间窗: 1 day
Incidence of systolic blood pressure less than 80% of baseline systolic blood pressure
次要结局
- Hypertension(1 day)
- Nausea and vomiting(1 day)
研究者
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital
