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NCT04128410 Clinical Trial

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

Aged Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04128410
Other study ID # 2019PHB169-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2019
Est. completion date October 2019

Study information
Verified date October 2019
Source Peking University People's Hospital
Contact Yi Feng, MD
Phone 08601088325590
Email yifeng65@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 77
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Yi Feng, MD

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients. The samples will be used to be determined plasma and CSF drug concentrations. perioperation
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