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

NCT04128410 | Unknown

• 1 other identifier: 2019PHB169-01
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Flurbiprofen Axetil; Cerebrospinal Fluid; Anesthesia, Spinal; Aged

Keywords

S-flurbiprofen, R-flurbiprofen; cerebrospinal fluid; aged

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (10)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yi Feng, MD: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Study Officials

• Yi Feng, MD

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Yi Feng, MD

CONTACT

08601088325590; yifeng65@sina.com

Han Yao

CONTACT

08601088325581; yaohan2016@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of department of anesthesiology and painmanagement

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)