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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027008
Receipt No. 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

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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
Email 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
Email passkey55555@gmail.com

Sponsor
Institute National Hospital Organization Fukuyama Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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