UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047598 |
|---|---|
| Receipt number | R000054277 |
| Scientific Title | Study of the side Effects and effectiveness of Sedatives in Endoscopy |
| Date of disclosure of the study information | 2022/04/27 |
| Last modified on | 2023/04/28 11:15:12 |
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Basic information
Public title
Study of the side Effects and effectiveness of Sedatives in Endoscopy
Acronym
Study of the side Effects and effectiveness of Sedatives in Endoscopy
Scientific Title
Study of the side Effects and effectiveness of Sedatives in Endoscopy
Scientific Title:Acronym
Study of the side Effects and effectiveness of Sedatives in Endoscopy
Region
| Japan |
Condition
Condition
Upper gastrointestinal endoscopy, colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sedatives are used to reduce discomfort in upper gastrointestinal endoscopy and colonoscopy. This study investigates the occurrence of side effects of these drugs and the optimal dose. In particular, the analysis will focus on the administration of pethidine alone. Also, we will confirm the discomfort reducing effect.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of side effects. Correlation between drug dose and side effects. Cut-off value that is less likely to cause side effects.
Key secondary outcomes
Discomfort reduction effect.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants undergoing endoscopic screening.
Key exclusion criteria
Participants who refused to use the information for research.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Majima |
Organization
Kameda Medical Center
Division name
Department of Health Management
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
maji-ken@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Majima |
Organization
Kameda Medical Center
Division name
Department of Health Management
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
Homepage URL
maji-ken@umin.ac.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda General Hospital Clinical Research Review Committee Office
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
Tel
04-7092-2211
I can not publish it.
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
| 2022 | Year | 04 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study. Data to be collected for the analysis of upper gastrointestinal endoscopy are as follows. Sedative usage status, recovery room record information including side effects and the presence or absence of rest extension, participants discomfort level, participants satisfaction, renal function, liver function, age, sex, current medical history, past medical history, BMI, height, smoking status, alcohol intake, history of endoscopy, endoscope model, with or without antispasmodic agent, biopsy performed during examination, administration of Lugols solution, with or without hiatal hernia, endoscopist information, inspection time.
For the analysis of colonoscopy are as follows. Sedative usage status, recovery room record information including side effects and the presence or absence of rest extension, participants discomfort level, participants satisfaction, renal function, liver function, age, sex, BMI, current medical history, past medical history, history of endoscopy, endoscope model, with or without antispasmodic agent, insertion time, withdrawal time, endoscopist information, with or without diverticulum.
Management information
Registered date
| 2022 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054277
