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临床试验/NCT01741610
NCT01741610已完成4 期

Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading

Cukurova University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
90
试验地点
2
主要终点
Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading

研究概览

简要总结

This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

详细描述

Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • elective caesarean section under spinal anaesthesia

排除标准

  • Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,
  • Pregnancy preinduced hypertension,
  • Being in active labour or requiring emergency caesarean section,
  • Any contraindication to regional anaesthesia such as local infection or bleeding disorders.

结局指标

主要结局

Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading

时间窗: Four Years

The primary study endpoint was the ephedrine requirement (incidence of hypotension).

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

Hakki Unlugenc

Prof Dr.

Cukurova University

研究点 (2)

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