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

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ClinicalTrials.gov Identifier: NCT04128410
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yi Feng, MD, Peking University People's Hospital

Brief 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.

Condition or disease
Flurbiprofen Axetil Cerebrospinal Fluid Anesthesia, Spinal Aged

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 77 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Group/Cohort
T1
At 5 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T2
At 10 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T3
At 15 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T4
At 20 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T5
At 25 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T6
At 30 minutes after flurbiprofen axetil injected intravenously, 14 patients' samples were required to be collected,including 7 younger patients
T7
At 35 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T8
At 40 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T9
At 45 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected
T10
At 50 minutes after flurbiprofen axetil injected intravenously, 7 aged patients' samples were required to be collected



Primary Outcome Measures :
  1. The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients. [ Time Frame: perioperation ]
    The samples will be used to be determined plasma and CSF drug concentrations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ASA I or lII, both sexes, aged 18-85 yr
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128410


Contacts
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Contact: Yi Feng, MD 08601088325590 yifeng65@sina.com
Contact: Han Yao 08601088325581 yaohan2016@sina.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Yi Feng, MD    08601088325590    yifeng65@sina.com   
Sponsors and Collaborators
Yi Feng, MD
Investigators
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Study Chair: Yi Feng, MD Peking University People's Hospital

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Responsible Party: Yi Feng, MD, Director of department of anesthesiology and painmanagement, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04128410    
Other Study ID Numbers: 2019PHB169-01
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yi Feng, MD, Peking University People's Hospital:
S-flurbiprofen, R-flurbiprofen
cerebrospinal fluid
aged
Additional relevant MeSH terms:
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Flurbiprofen
Flurbiprofen axetil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action