UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009304 |
|---|---|
| Receipt number | 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 00:45:43 |
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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
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
Sponsor or person
Institute
Hirosaki University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010926
