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

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.

Study Overview

• Status: Unknown
• Conditions: Aged; Flurbiprofen Axetil; Anesthesia, Spinal; Cerebrospinal Fluid

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.

• Study Type: Observational
• Enrollment (Anticipated): 77

Contacts and Locations

• Study Contact: Name: Yi Feng, MD; Phone Number: 08601088325590; Email: yifeng65@sina.com
• Study Contact Backup: Name: Han Yao; Phone Number: 08601088325581; Email: yaohan2016@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Yi Feng, MD; Phone Number: 08601088325590; Email: yifeng65@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ASA I or lII, both sexes, aged 18-85 yr

Description

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 Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yi Feng, MD

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: cerebrospinal fluid; aged; S-flurbiprofen, R-flurbiprofen
• Other Study ID Numbers: 2019PHB169-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No