UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026941 |
|---|---|
| Receipt number | R000020506 |
| Scientific Title | Pharmacokinetics of fentanyl administered to epidural space |
| Date of disclosure of the study information | 2017/04/11 |
| Last modified on | 2018/10/12 09:57:32 |
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Basic information
Public title
Pharmacokinetics of fentanyl administered to epidural space
Acronym
Pharmacokinetics of fentanyl administered to epidural space
Scientific Title
Pharmacokinetics of fentanyl administered to epidural space
Scientific Title:Acronym
Pharmacokinetics of fentanyl administered to epidural space
Region
| Japan |
Condition
Condition
Patients undergoing elective surgery under general and epidural anesthesia
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the time course of plasma concentration of fentanyl administered to epidural space
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma concentration of fentanyl
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 undergoing elective surgery under general and epidural anesthesia
Key exclusion criteria
Severe cardiac, hepatic, or renal disease, body mass index equal or greater than 35, and allergy to fentanyl or local anesthetics
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masui, Kenichi |
Organization
National Defense Medical College
Division name
Anesthesiology
Zip code
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
04-2995-1692
kenichi@masuinet.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masui, Kenichi |
Organization
National Defense Medical College
Division name
Anesthesiology
Zip code
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
04-2995-1692
Homepage URL
kenichi@masuinet.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 04 | Month | 11 | 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
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Fentanyl is administered epirulally as necessary for surgery. Arterial blood samples are drawn every 3 to 120 minutes.
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020506
