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临床试验/NCT04025918
NCT04025918已完成2 期

Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

KK Women's and Children's Hospital0 个研究点目标入组 216 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
相关药物

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

Experimental

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

Active Comparator

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

Experimental

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

Active Comparator

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

Experimental

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

Active Comparator

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

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sng Ban Leong

Principal Investigator

KK Women's and Children's Hospital

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