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临床试验/NCT02937792
NCT02937792Unknown不适用

Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
vital signs

研究概览

简要总结

To test the safety of high dose spinal in elective CS after prolonged sitting position.

详细描述

This is a prospective double-blind randomized study, designed to include cases in two groups (using epical program for sample size calculation), one study groups and one control group (parallel). Each group should have at least 30 female patients scheduled for elective caesarean section with a total of 60 cases.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance

排除标准

  • Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal

研究组 & 干预措施

experimental

Experimental

one group with intrathecal 15 mg bupivacaine

干预措施: intrathecal 15 mg bupivacaine (Drug)

结局指标

主要结局

vital signs

时间窗: 45 minutes

blood pressure, heart rate

次要结局

  • complications(45 minutes)

研究者

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

Hassan Mohamed Ali

lecturer in anesthesia department Cairo university

Cairo University

研究点 (1)

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