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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027630
Receipt No. R000031658
Scientific Title Molecular genetic elucidation of pharmacokinetics of propofol
Date of disclosure of the study information 2017/06/04
Last modified on 2018/12/04

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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 affecting pharmacokinetics of propofol by japonica array
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
Middle name
Last name Masanori Yamauchi
Organization Tohoku University School of Medicine
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
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
Middle name
Last name Akihiro Kanaya
Organization Tohoku University School of Medicine
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
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
Institute Department of Anesthesiology and Perioperative Medicine, Tohoku University School of Medicine
Institute
Department

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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 29 Day
Last follow-up date
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
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.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


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