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临床试验/NCT03478618
NCT03478618Unknown早期 1 期

Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome

Assiut University0 个研究点目标入组 60 人开始时间: 2018年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
60
主要终点
incidence of hypotension

研究概览

简要总结

To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • more than 36 weeks gestation
  • singleton pregnant women planned for elective caesarian section

排除标准

  • patient refusal.
  • psychiatric disorders.
  • parturient <36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing.
  • absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).

研究组 & 干预措施

Group R

Active Comparator

30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative.

干预措施: Lactated Ringer (Drug)

Group L

Active Comparator

30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative.

干预措施: Lactated Ringer (Drug)

结局指标

主要结局

incidence of hypotension

时间窗: 1 hour

decrease in systolic blood pressure more than 20% of base line

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bola Fawzi Mekhail Sedrak

principal investigator

Assiut University

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