UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010547 |
|---|---|
| Receipt number | R000012333 |
| Scientific Title | A prospective study under endoscopic treatment which examines the convenient propofol use |
| Date of disclosure of the study information | 2013/04/19 |
| Last modified on | 2014/04/21 13:33:28 |
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Basic information
Public title
A prospective study under endoscopic treatment which examines the convenient propofol use
Acronym
A prospective study under endoscopic treatment which examines the convenient propofol use
Scientific Title
A prospective study under endoscopic treatment which examines the convenient propofol use
Scientific Title:Acronym
A prospective study under endoscopic treatment which examines the convenient propofol use
Region
| Japan |
Condition
Condition
The patient who owns the digestive diseases diagnosed as passing and the endoscopic treatment under vein general anesthesia being requirement
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The endoscopic treatment in the deep sedation validates simple sedation by the propofol of minimum quantity in the bottom general anesthesias of vein in the patient which is adapted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
validity by propofol use by this medication method
Key secondary outcomes
evaluation of dose by the background factor difference of patient with the use of propofol
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-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
Treatment will set in necessary 50 cases endoscopically by December 31, 2016 from the ethics committee approved the study. It is kept calm, increasing from the amount of 1 ml/h for 4 minutes of weight at a very small amount for lowest available doses (1 ml for 20 minutes of weight), and maintenance for use of propofol are needed on an attachment 1% at the time of induction of anesthesia 10 seconds.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who owns the digestive diseases diagnosed as passing and the endoscopic treatment under vein general anesthesia being requirement
Key exclusion criteria
1) The example of Informed Consent (IC) refusal.2) The direction which has merged critical liver disease, cardiac disease, a respiratory ailment, etc., and is considered that operative endoscopy is difficult.3)patient who haveallergy to eggs.4)patient who have unknown or serious allergic constitution.
4)the patient whom the doctor specializing in an exam judged to be unfit as focus of our study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kenshi matsumoto |
Organization
Juntendo university
Division name
gastroenterology
Zip code
Address
2-1-1 hongo bunkyo-ku Tokyo
TEL
03-3813-8111
kmatumo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kenshi matsumoto |
Organization
juntendo university
Division name
gastroenterology
Zip code
Address
2-1-1 hongo bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
http://www.juntendo.ac.jp/hospital/clinic_c/gcp/rinsho/rinsho02.html
kmatumo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
順天堂大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
http://www.juntendo.ac.jp/hospital/clinic_c/gcp/rinsho/rinsho02.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.juntendo.ac.jp/hospital/clinic_c/gcp/rinsho/rinsho02.html
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
Preinitiation
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 19 | Day |
Last modified on
| 2014 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012333
