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临床试验/NCT02102607
NCT02102607已完成不适用

Effect of Age on the Median Effective Dose(ED50) for Motor Block With Intrathecal Ropivacaine

China Three Gorges University, Yichang, China1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
the dose of intrathecal ropivacaine

研究概览

简要总结

The primary aim of this study was to determine the median effective dose (ED50) for motor block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the effect of age on ED50 required for motor block.

详细描述

This study was performed in adult patients undergoing transurethral, urological or lower limb surgery under combined spinal and epidural anesthesia. Patients were stratified according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component of the anesthetic was established by bolus administration of various up-and-down doses of 0.75% ropivacaine, determined by Dixon's method, with the first patient receiving 15 mg, and with testing intervals of 1.5 mg according to failure or success of the preceding patient's motor block. The degree of motor block after intrathecal administration of each dose was evaluated by the modified Bromage and Hip motor function score. The primary outcome was obtained by administration of the mean dosage that was determined from the midpoints of all independent pairs of patients involving a crossover from failure to success during 5 minutes after the spinal injection. The ED50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Other endpoints were included on the basis of sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.

研究设计

研究类型
Observational

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia

排除标准

  • Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant

结局指标

主要结局

the dose of intrathecal ropivacaine

时间窗: at 5-min after administered ropivacaine

次要结局

未报告次要终点

研究者

发起方
China Three Gorges University, Yichang, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mingquan Chen

the First College of Clinical Medical Science, China Three Gorges University (China)

China Three Gorges University, Yichang, China

研究点 (1)

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