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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011430
Receipt No. R000013382
Official scientific title of the study Patient's factors influenced on propofol blood concentrations when using target controlled infusion system(DiprifusorTM)
Date of disclosure of the study information 2013/08/10
Last modified on 2013/12/19

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Basic information
Official scientific title of the study Patient's factors influenced on propofol blood concentrations when using target controlled infusion system(DiprifusorTM)
Title of the study (Brief title) Patient's factors influenced on propofol blood concentrations
Region
Japan

Condition
Condition Patients scheduled for general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigating patient's factor influenced on propofol blood concentrations when using target contorolled infusion system(Diprifusor TM)
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measured blood propofol concentrations
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Propofol infusion is injected intravenously with target controlled infusion system.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Patients scheduled for elective surgery under general anesthesia.
Key exclusion criteria Drug or alcohol abuse, and hepatic or renal impairment.
Target sample size 100

Research contact person
Name of lead principal investigator Michiaki Yamakage
Organization Sapporo medical university school of medicine
Division name Department of anesthesiolofy
Address S1W16, chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email yamakage@sapmed.ac.jp

Public contact
Name of contact person Yukitoshi Niiyama
Organization Sapporo medical university school of medicine
Division name Department of anesthesiology
Address S1W16, chuo-ku, Sapporo, Japan
TEL 011-611-2111
Homepage URL
Email niiyama@sapmed.ac.jp

Sponsor
Institute Sapporo mecdical university school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 札幌医科大学麻酔科学講座

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 10 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 08 Month 01 Day
Anticipated trial start date
2013 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2013 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013382


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