UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027008 |
|---|---|
| Receipt number | R000030969 |
| Scientific Title | Randomized blind group comparison test on urinary catheter discomfort alleviation effect by xylocaine concentration when urinary catheter with lumen for medical solution administration is used |
| Date of disclosure of the study information | 2017/04/17 |
| Last modified on | 2018/02/11 13:36:58 |
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Basic information
Public title
Randomized blind group comparison test on urinary catheter discomfort alleviation effect by xylocaine concentration when urinary catheter with lumen for medical solution administration is used
Acronym
Randomized blind group comparison trial of reduction of urethral discomfort by NMOC catheter
Scientific Title
Randomized blind group comparison test on urinary catheter discomfort alleviation effect by xylocaine concentration when urinary catheter with lumen for medical solution administration is used
Scientific Title:Acronym
Randomized blind group comparison trial of reduction of urethral discomfort by NMOC catheter
Region
| Japan |
Condition
Condition
Patient planned to use a urethral catheter at the perioperative period
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Oto-rhino-laryngology | Orthopedics |
| Urology | Anesthesiology | Oral surgery |
| Plastic surgery | Intensive care medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A side slit urethral catheter called NMOC - 3 WAY catheter has been approved and released to alleviate urethral catheter discomfort. There is a report that the NMOC-3 WAY catheter can improve urinary catheter discomfort, which allows a surface anesthetic such as xylocaine to be injected into the urethral mucosa from a side slit for chemical solution. By using the NMOC - 3 WAY catheter, it can be expected to prevent disturbance caused by catheter stimulation after surgery, reduce discomfort during catheter insertion, and so on. However, there is no data concerning the concentration and amount of xylocaine injected from the side tube, and it is administered by judgment of each anesthesiologist.
Generally 1% xylocaine or 2% xylocaine is used. When 2% xylocaine is used, the risk of local anesthetic poisoning increases. There is a possibility that 1% xylocaine may not be effective enough. Therefore, in order to investigate whether xylocaine concentration injected from the side tube of the NMOC-3 WAY catheter has a different effect, a prospective randomized test is conducted. NMOC - 3 WAY catheters have not been reported clinically examined scientific articles. Therefore, it is unknown whether administration of xylocaine injected from the side tube is really effective, so it is necessary to compare it with the salty group. Compared with three groups of physiological saline (placebo) group, 1% xylocaine group, 2% xylocaine group.
There is a report that postoperative pain exacerbates delirium and delirium affects the patient's life prognosis. In this clinical trial, there is a possibility of decreasing the incidence of delirium after surgery by relieving discomfort of the urinary catheter. Delirium is also evaluated in secondary evaluation items.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
VAS scale of urinary catheter discomfort before exiting the operating room and before bedtime on the day of surgery.
VAS scale of wound pain before exit from the operating room and before bedtime on the day of surgery.
Key secondary outcomes
CAM-ICU score of delirium on the night of surgery, general state before surgery, surgical invasion, changes in vital signs during and after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
It is classified into three groups with chemical liquid injected from the side tube of NMOC-3 WAY catheter.
Saline solution (Placebo) 5 ml
Interventions/Control_2
It is classified into three groups with chemical liquid injected from the side tube of NMOC-3 WAY catheter.
1% Xylocaine 5 ml
Interventions/Control_3
It is classified into three groups with chemical liquid injected from the side tube of NMOC-3 WAY catheter.
2 % Xylocaine 5 ml
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 who undergo general anesthesia without epidural anesthesia for surgery of gastrointestinal surgery, orthopedic surgery, urology, respiratory surgery.
Male patient who intends to place a urinary catheter.
Patients whose age at registration is 20 years or older.
Patients who are class 1 (normal health patients) or class 2 (patients with mild systemic diseases and whose daily activities are restricted) in the ASA-PS (ASA physical status) classification.
Patients who have written consent for this study.
Key exclusion criteria
Patients who undergo urethral surgery.
Patients with a history of hypersensitivity to xylocaine or amide type local anesthetic.
Patients who have suffered a feeling after having undergone surface anesthesia in dental practice.
Persons who can bear arrhythmia on the electrocardiogram or patients taking oral antiarrhythmic drugs.
Patient who has consciousness disorder or who has difficulty communicating and may not obtain a valid evaluation.
Patients with moderate renal failure or liver failure.
Patients who underwent epidural anesthesia.
Patients taking opioid analgesics.
Patients who have difficulty communicating after surgery.
Patients with delirium and delirium treatment medicine.
Emergency operation.
Patients who did not obtain consent to this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suita koukyou |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Zip code
Address
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
TEL
086-235-7778
passkey55555@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suita koukyou |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Zip code
Address
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
TEL
086-235-7778
Homepage URL
passkey55555@gmail.com
Sponsor or person
Institute
National Hospital Organization Fukuyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Fukuyama Medical Center
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
| 2017 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 16 | Day |
Last modified on
| 2018 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030969
