UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009015 |
|---|---|
| Receipt number | R000010577 |
| Scientific Title | Prospective observational study about factors (genotyping of metabolic enzyme, sex and age etc) which influence the blood concentration of propofol during continuous infusion |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2015/10/01 09:37:15 |
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Basic information
Public title
Prospective observational study about factors (genotyping of metabolic enzyme, sex and age etc) which influence the blood concentration of propofol during continuous infusion
Acronym
Study about the factors which influence the blood concentration of propofol during continuous infusion
Scientific Title
Prospective observational study about factors (genotyping of metabolic enzyme, sex and age etc) which influence the blood concentration of propofol during continuous infusion
Scientific Title:Acronym
Study about the factors which influence the blood concentration of propofol during continuous infusion
Region
| Japan |
Condition
Condition
the patients undergoing a surgery by administration of propofol
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To reveal the relationship between the blood concentration of propofol and genetic polymorphism (UGT1A9 I399C>T, *5, CYP2B6 *4, *5, *6 (G516T, A785G), *23, *26), age, sex, blood pressure, weight, body temperature and BIS values.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the blood concentration of propofol and genetic polymorphism (UGT1A9 I399C>T, *5, CYP2B6 *4, *5, *6 (G516T, A785G), *23, *26), age, sex, blood pressure, weight, body temperature and BIS values.
Key secondary outcomes
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
1.Patients who is undergoing surgery which will be longer than 4 hours at Kyushu University Hospital or Kyushu Medical Center
2.Use of target controlled propofol infusion pumps TE-371 (TERUMO, Japan)
3.Direct measurement of arterial pressure monitoring
4.Patients who can understand this study and give informed consent
5.Patients who are older than 20 years old
Key exclusion criteria
1.Hemoglobin<10 g/dL
2.American Society of Anesthesiologists Physical Status class III or higher
3.Child-Pugh score class B and C
4.Estimate glomerular filtration rate < 60 mL/min/1.73 m2
5.Surgery of liver and kidney
6.Not appropriate to this study by other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sasaguri |
Organization
Faculty of Medicical Science, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6082
sasaguri@clipharm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yoshihara |
Organization
Faculty of Medicical Science, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6082
Homepage URL
tatsuya@clipharm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology,
Faculty of Medicical Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The blood sample is collected at 4 hours after propofol continuous administration started, and the plasma concentrations of propofol are analyzed. Blood pressure, pulse rate, body temperature and BIS values before blood collection are recorded. Genetic polymorphisms of CYP2B6 and UGT1A9 are analyzed.
Management information
Registered date
| 2012 | Year | 10 | Month | 01 | Day |
Last modified on
| 2015 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010577
