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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009304
Receipt No. R000010926
Scientific Title Investigation of plasma remifentanil elimination rate and improvement of safety
Date of disclosure of the study information 2012/11/10
Last modified on 2012/11/10

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Basic information
Public title Investigation of plasma remifentanil elimination rate and improvement of safety
Acronym Measurement of Remifentanil blood concentration
Scientific Title Investigation of plasma remifentanil elimination rate and improvement of safety
Scientific Title:Acronym Measurement of Remifentanil blood concentration
Region
Japan

Condition
Condition Patients who underwent sceduled operation under general anesthesia using remifentanil
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To figure out the remifentanil
pharmacokinetic
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Assesment of remifentanil blood concentrations at 0,1,3,5,7,10,15,20 and 30 min after termination of remifentanil infusion at 0.2 mcg/kg/min
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 Patients who underwent sceduled operation under general anesthesia using remifentanil
Key exclusion criteria Patients who have severe cardiovascular disease or severe anemia
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Kudo
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 5 Zaifu-cho, Hirosaki 036-8562, Japan
TEL 0172-33-5113
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Kudo
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 5 Zaifu-cho, Hirosaki 036-8562, Japan
TEL 0172-33-5113
Homepage URL
Email

Sponsor
Institute Hirosaki University School of Medicine
Institute
Department

Funding Source
Organization none
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
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 弘前大学医学部附属病院(青森県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2012 Year 11 Month 10 Day
Last modified on
2012 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010926

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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