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临床试验/NCT04128410
NCT04128410Unknown不适用

A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients

Yi Feng, MD1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2019年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
77
试验地点
1
主要终点
The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients.

研究概览

简要总结

The project will apply the methods of clinical observation experiment to study the central transport characteristics of flurbiprofen axetil by detecting S-flurbiprofen and R-flurbiprofen concentrations in cerebral-spinal fluid(CSF) after intravenous injection of flurbiprofen axetil in elderly patients.

详细描述

The patients undergoing spinal anesthesia for lower extremity surgery will be studied. Flurbiprofen axetil 100mg will be injected intravenously. CSF 1ml and blood 2ml will be obtained simultaneously every 5 minutes after intravenous injection in 50 min( T1~T10).CSF and blood samples will be used to detected S-flurbiprofen and R-flurbiprofen concentrations by using Liquid Chromatography-Mass Spectrometry. And the CSF/blood S-flurbiprofen and R-flurbiprofen concentrations ratio were calculated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing lower extremity surgery under spinal or combined spinal-epidural anesthesia will be selected.

排除标准

  • asthma, liver insufficiency, renal insufficiency, peptic ulcer, allergy to NSAIDs, and a history use of NSAIDs within two weeks before operation.

结局指标

主要结局

The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients.

时间窗: perioperation

The samples will be used to be determined plasma and CSF drug concentrations.

次要结局

未报告次要终点

研究者

发起方
Yi Feng, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yi Feng, MD

Director of department of anesthesiology and painmanagement

Peking University People's Hospital

研究点 (1)

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