UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019625
Receipt No. 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 (Ver. 8)

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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
Last 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
1st 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
Institute Juntendo university
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022685