UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015289 |
|---|---|
| Receipt number | R000009224 |
| Scientific Title | Clinical trial using the urethra catheter having a function to operate on for infiltration anesthesia for urethra mucous membrane |
| Date of disclosure of the study information | 2014/09/30 |
| Last modified on | 2014/09/30 11:33:20 |
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Basic information
Public title
Clinical trial using the urethra catheter having a function to operate on for infiltration anesthesia for urethra mucous membrane
Acronym
Clinical trial using the urethra catheter having a function to operate on for infiltration anesthesia for urethra mucous membrane
Scientific Title
Clinical trial using the urethra catheter having a function to operate on for infiltration anesthesia for urethra mucous membrane
Scientific Title:Acronym
Clinical trial using the urethra catheter having a function to operate on for infiltration anesthesia for urethra mucous membrane
Region
| Japan |
Condition
Condition
The patient that it was planned general anesthesia
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect at the time of the urethra catheter withdrawal with the intraurethral administration of Xylocaine from a catheter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Medicinal solution intraurethral administration
Interventions/Control_2
Nothing
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Urethra catheter detains you for the perioperative period (the patient that size 14F) is planned.)
Patient equivalent to PS1 of the ASA-PS(ASA physical status) classification or PS2
Generally PS1: is good. There are no complications.
I have PS2: slight whole body disease, but the daily living activity is normal.
The patient who I use it together with general anesthesia, and does not perform the pain-killer dosage of an epidural or the continuation
Key exclusion criteria
1) An urethral patient operated on.
2) It is a patient with a history of the past of hypersensitivity for a Xylocaine or amide type local anesthetic.
3) A patient accepted arrhythmia in an electrocardiogram or the patient who is taking antiarrhythmic.
4) The patient whom it is not got the evaluation that disturbance of consciousness or mutual understanding is difficult, and is fair from.
5) The patient whom it was judged the judgment of the doctor to be inappropriate as an object
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kazuhiro kubo |
Organization
gunma university
Division name
department of anaethesia
Zip code
Address
Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi City 3718511, Japan
TEL
027-220-8460
kubo1218@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazuhriro kubo |
Organization
gunma university
Division name
department of anaethesia
Zip code
Address
Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi City 3718511, Japan
TEL
027-220-8460
Homepage URL
kubo1218@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
群馬大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 30 | Day |
Last modified on
| 2014 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009224
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
