UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018153 |
|---|---|
| Receipt number | R000021025 |
| Scientific Title | Evaluation of the urethral catheter related symptoms administering Lidocaine via the catheter. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/07/01 18:16:17 |
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Basic information
Public title
Evaluation of the urethral catheter related symptoms administering Lidocaine via the catheter.
Acronym
Evaluation of the urethral catheter related symptoms administering Lidocaine via the catheter.
Scientific Title
Evaluation of the urethral catheter related symptoms administering Lidocaine via the catheter.
Scientific Title:Acronym
Evaluation of the urethral catheter related symptoms administering Lidocaine via the catheter.
Region
| Japan |
Condition
Condition
Patients planned with 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 urethral catheter withdrawal with the intraurethral administration of lidocaine from the catheter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the catheter related symptoms
Key secondary outcomes
Change of the catheter related symptoms
Base
Study type
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
| Medicine |
Interventions/Control_1
Lidocaine administration
Interventions/Control_2
Saline administration
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
Key inclusion criteria
Patients with Urethral catheter(14F).
Patients with ASA-PS 1 or 2.
Patients with catheter symptoms 3/5 or more, 30 minutes after surgery.
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 | Tomonobu Sato |
Organization
Gunma University Hospital
Division name
Department of anethesiology
Zip code
Address
Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi City 3718511, Japan
TEL
027-220-8454
m14702011@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonobu Sato |
Organization
Gunma University Hospital
Division name
Department of anethesiology
Zip code
Address
Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi City 3718511, Japan
TEL
027-220-8454
Homepage URL
m14702011@gunma-u.ac.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
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
| 2015 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | 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
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2015 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021025
