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 |
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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(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
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
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
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
