UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	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
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	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
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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