UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027630
Receipt number R000031658
Scientific Title Molecular genetic elucidation of pharmacokinetics of propofol
Date of disclosure of the study information 2017/06/04
Last modified on 2023/01/04 16:02:13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Molecular genetic elucidation of pharmacokinetics of propofol

Acronym

Relationship between propofol and genes

Scientific Title

Molecular genetic elucidation of pharmacokinetics of propofol

Scientific Title:Acronym

Relationship between propofol and genes

Region

Japan


Condition

Condition

Relationship between propofol and genes

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The aim of this study is to verify the impact of genetic factors after a single intravenous injection of propofol.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of candidate SNPs(UGT1A9,CYP2B6,CYP2C9 affecting pharmacokinetics of propofol

Key secondary outcomes

Validation of candidate SNPs


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

ASA1-2
elective surgery

Key exclusion criteria

weight<70%, >130%
disease or injury affecting the central nervous system
recent use of psychoactive or analgesic medication

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masanori
Middle name
Last name Yamauchi

Organization

Tohoku University School of Medicine

Division name

Department of Anesthesiology and Perioperative Medicine

Zip code

9808574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan

TEL

022-717-7321

Email

a-kanaya@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Kanaya

Organization

Tohoku University School of Medicine

Division name

Department of Anesthesiology and Perioperative Medicine

Zip code

9808574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan

TEL

022-717-7321

Homepage URL


Email

a-kanaya@med.tohoku.ac.jp


Sponsor or person

Institute

Department of Anesthesiology and Perioperative Medicine, Tohoku University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

IRB of Tohoku University

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan

Tel

0227178007

Email

med-kenkyo@grp.tohoku.ac.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

2017 Year 06 Month 04 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

100

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 29 Day

Date of IRB

2017 Year 05 Month 26 Day

Anticipated trial start date

2017 Year 05 Month 29 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

N/A


Management information

Registered date

2017 Year 06 Month 04 Day

Last modified on

2023 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name