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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002009
Receipt No. 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

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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
Email 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
Email kumai@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine, Department of Pharmacogenomics
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002446

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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