UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002009 |
|---|---|
| Receipt number | R000002446 |
| Scientific Title | The Effect of genetic polymorphism of CYP2B6 and UGT1A9 on the Pharamcokinetics and Pharmacodynamics of Propofol |
| Date of disclosure of the study information | 2009/05/26 |
| Last modified on | 2014/11/06 13:40:26 |
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Basic information
Public title
The Effect of genetic polymorphism of CYP2B6 and UGT1A9 on the Pharamcokinetics and Pharmacodynamics of Propofol
Acronym
The genetic polymorphism is related to pharmacodynamics of propofol
Scientific Title
The Effect of genetic polymorphism of CYP2B6 and UGT1A9 on the Pharamcokinetics and Pharmacodynamics of Propofol
Scientific Title:Acronym
The genetic polymorphism is related to pharmacodynamics of propofol
Region
| Japan |
Condition
Condition
The patients are surgical operation with propofol in the St. Marianna University Hospital
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In this experiment, we are investigate that the effect of genetic polymorphism of CYP2B6 and UGT1A9 on the pharamcokinetics and pharmacodynamics of propofol
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The recovery of consciousness time, polymorphism of CYP2B6 and UGT1A9
Key secondary outcomes
Pharmacokinetics parameter of propofol
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
The patients using propofol as an anesthetics
Key exclusion criteria
The patients did not informed consent. The propofol administration dosage is varied. The patients are transfusion during surgical operation. The patients have infection. The patients is under the confusion, ileus, agnosis, resection of stomach, disorder of liver function, disorder of kidney function, suppress of breathing, chronic obstructive pulmonary disease, asthma, heart failure with chronic pulmonary disease, and/or seizure. The medical doctor is estimate that the patients cannot entry of study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Kumai |
Organization
St. Marianna University School of Medicine
Division name
Department of Pharmacogenomics
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL
044-977-8111
kumai@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Kumai |
Organization
St. Marianna University School of Medicine
Division name
Department of Pharmacogenomics
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL
044-977-8111
Homepage URL
kumai@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Department of Pharmacogenomics
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine, Department of Pharmacogenomics
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
St. Marianna University School of Medicine, Department of Anesthesiology., Showa Pharmaceutical University, Department of Drug Metabolism and Pharmacokinetics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The blood is collect at steady state of propofol to estimate of maximum concentration of propofol. And, the blood is collect at 10min, 20min, 30min, and 60min after last administration of propofol. The awakening time of patient estimate using the awakening score after last administration of propofol. Genomic DNA is extract from white blood cell. And, genetic polymorphisms of CYP2B6 and UGT1A9 are analysis by PCR-RFLP method and direct sequence analysis. Plasma concentration of propofol is analysis by HPLC method.
Management information
Registered date
| 2009 | Year | 05 | Month | 26 | Day |
Last modified on
| 2014 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002446
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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