临床试验/NCT00974961

NCT00974961Unknown4 期

Comparison of the Effects of Levobupivacaine and Bupivacaine on Heart Rate Variability in Spinal Anesthesia

National Taiwan University Hospital1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2009年9月最近更新: 2010年3月18日

适应症

干预措施

试验速览

阶段: 4 期
发起方: National Taiwan University Hospital
入组人数: 70
试验地点: 1
主要终点: HRV values

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.

详细描述

Obtain the heart rate variability (in means and standard deviation, including the high frequency, low frequency and its ratio) data of before and after spinal anesthesia with ECG (and Heart Rate Variability Analyzer) in 2 groups. Meanwhile, record the blood pressure on each subject.

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: Single (Participant)

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Indicated for spinal anesthesia

排除标准

•Allergic reaction to local anesthetics
•Coagulopathy
•Severe spinal deformity
•Cardiac diseases
•Metabolic diseases (such as DM, thyroid or adrenal diseases)

研究组 & 干预措施

Levobupivacaine

Active Comparator

Lumbar puncture with Levobupivacaine for spinal anesthesia

干预措施: bupivacaine, levobupivacaine (Drug)

Bupivacaine

Active Comparator

Lumbar puncture with Bupivacaine for spinal anesthesia

干预措施: bupivacaine, levobupivacaine (Drug)

结局指标

主要结局

HRV values

时间窗: 5 minutes after drug administration

次要结局

未报告次要终点

研究者

发起方

National Taiwan University Hospital

申办方类型

Other

研究点 (1)

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