UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019625
Receipt number R000022685
Scientific Title The mechanism of action of anti-inflammatory effects of propofol in macrophages
Date of disclosure of the study information 2015/11/09
Last modified on 2019/05/07 10:44:50

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Basic information

Public title

The mechanism of action of anti-inflammatory effects of propofol in macrophages

Acronym

The mechanism of action of anti-inflammatory effects of propofol in macrophages

Scientific Title

The mechanism of action of anti-inflammatory effects of propofol in macrophages

Scientific Title:Acronym

The mechanism of action of anti-inflammatory effects of propofol in macrophages

Region

Japan


Condition

Condition

sepsis acute_respiratory_distress_syndrome surgical stress

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is said to have anti-inflammatory effects in the intravenous anesthetics typified by propofol.
In this study, we aim to elucidate the mechanism of its anti-inflammatory action.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Production of inflammatory cytokines

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Propofol concentration was varied to observe the changes in macrophages

Interventions/Control_2

No propofol was varied to observe the changes in macrophages

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

In 20 years of age or older , history healthy people with no history we are interested in helping us to understand bled the significance of research

Key exclusion criteria

Patients with diabetes mellitus , hyperlipidemia , autoimmune diseases , have a steroid oral

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Tsukasa
Middle name
Last name Kochiyama

Organization

Juntendo university

Division name

Anesthesiology

Zip code

113-0031

Address

2-1-1Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

tsukasa.coach.1109@gmail.com


Public contact

Name of contact person

1st name Tsukasa
Middle name
Last name Kochiyama

Organization

Juntendo university

Division name

Anesthesiology

Zip code

1130031

Address

2-1-1Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

tsukasa.coach.1109@gmail.com


Sponsor or person

Institute

Juntendo university

Institute

Department

Personal name



Funding Source

Organization

juntendo university graduate school

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University

Address

2-1-1Hongo, Bunkyo-ku, Tokyo

Tel

03-3813-3111

Email

ju-masui@juntendo-urayasu.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 09 Day


Related information

URL releasing protocol

https://doi.org/10.1155/2019/1919538

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1155/2019/1919538

Number of participants that the trial has enrolled

6

Results

Propofol suppresses the progression of inflammation through the attenuation of IL-6 and IL-1-beta production in human M1 macrophages. Nrf2 is involved in the inhibitory activity of propofol via GABAA receptor during M1 polarization. Therefore, propofol administration can suppress postoperative inflammation following invasive surgical procedures.

Results date posted

2019 Year 05 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Volunteer

Participant flow

Peripheral blood was obtained from healthy volunteers, all of whom provided written informed consent.

Adverse events

none

Outcome measures

RT-PCR,ELISA,Western blot,siRNA

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 11 Month 01 Day

Date of IRB

2015 Year 11 Month 07 Day

Anticipated trial start date

2015 Year 11 Month 09 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 04 Day

Last modified on

2019 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022685


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name