UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061643 |
|---|---|
| Receipt number | R000070529 |
| Scientific Title | Efficacy and Safety of Remimazolam Sedation in Outpatient Endoscopic Ultrasonography: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/21 |
| Last modified on | 2026/05/20 18:40:32 |
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Basic information
Public title
Efficacy and Safety of Remimazolam Sedation in Outpatient Endoscopic Ultrasonography: A Multicenter Randomized Controlled Trial
Acronym
Y-ROSE Study
Scientific Title
Efficacy and Safety of Remimazolam Sedation in Outpatient Endoscopic Ultrasonography: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
Y-ROSE Study
Region
| Japan |
Condition
Condition
Pancreatobiliary diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of remimazolam sedation for outpatient pancreatobiliary endoscopic ultrasonography (EUS) in a multicenter randomized trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ate of achieving a Modified Aldrete score of 9 or higher at 30 minutes after completion of the procedure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Participants will be randomly assigned to receive midazolam intravenously, and outpatient pancreatobiliary endoscopic ultrasonography (EUS) will be performed under sedation.
Interventions/Control_2
Participants will be randomly assigned to receive remimazolam intravenously, and outpatient pancreatobiliary endoscopic ultrasonography (EUS) will be performed under sedation.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 years or older.
2.Patients scheduled to undergo outpatient EUS for evaluation of pancreatobiliary diseases.
3/Patients from whom written informed consent has been obtained.
Key exclusion criteria
1.Patients undergoing upper gastrointestinal endoscopy on the same day as the EUS examination.
2.Patients who have already participated in this study.
3.Patients with an allergy to benzodiazepines.
4.Patients with acute angle-closure glaucoma.
5.Patients with myasthenia gravis.
6.Patients with an American Society of Anesthesiologists Physical Status (ASA-PS) classification of III or higher.
7.Pregnant or breastfeeding women.
8.Patients deemed inappropriate for participation in this study by the attending physician for any other reason.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Suzuki |
Organization
Yokohama Rosai Hospital
Division name
Department of Gastroenterology
Zip code
220-0073
Address
3211 Kozukue-cho, Kohoku-ku, Yokohama, Kanagawa, Japan
TEL
045-474-8111
d07sm056@gmail.com
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Suzuki |
Organization
Yokohama Rosai Hospital
Division name
Department of Gastroenterology
Zip code
220-0073
Address
3211 Kozukue-cho, Kohoku-ku, Yokohama, Kanagawa, Japan
TEL
045-474-8111
Homepage URL
d07sm056@gmail.com
Sponsor or person
Institute
Clinical Research Center, Yokohama Rosai Hospital, Japan Organization of Occupational Health and Safety
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
Yokohama Rosai Hospital Ethics Committee
Address
3211 Kozukue-cho, Kohoku-ku, Yokohama, Kanagawa, Japan
Tel
045-474-8111
d07sm056@gmail.com
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
横浜労災病院、横浜市立大学附属病院、NTT東日本関東病院、横浜医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 20 | Day |
Last modified on
| 2026 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070529
