UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059792 |
|---|---|
| Receipt number | R000068366 |
| Scientific Title | A prospective observational study on remimazolam use and patient satisfaction in real-world clinical practice |
| Date of disclosure of the study information | 2025/11/16 |
| Last modified on | 2025/11/18 17:49:37 |
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Basic information
Public title
A prospective observational study on remimazolam use and patient satisfaction in real-world clinical practice
Acronym
Daily clinical practice of remimazolam (DOREMI) study
Scientific Title
A prospective observational study on remimazolam use and patient satisfaction in real-world clinical practice
Scientific Title:Acronym
Daily clinical practice of remimazolam (DOREMI) study
Region
| Japan |
Condition
Condition
Patients undergoing upper gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to optimize safe and comfortable sedation management by evaluating real-world patterns of its use, recovery room stay and recovery time, the incidence of complications, patient satisfaction, and symptoms and interference with daily life up to the day after the procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery room stay (time until the Modified Aldrete Score reaches 9)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo upper gastrointestinal endoscopy using remimazolam at the study institution for screening, surveillance, or diagnostic purposes between the date of UMIN registration publication and March 2028.
2. Patients who agree to participate in the study and are 18 years of age or older at the time of obtaining informed consent.
Key exclusion criteria
1. Patients with ASA physical status classification IV or higher
2. Patients with acute angle-closure glaucoma
3. Patients with myasthenia gravis
4. Patients with a history of allergy to any component of remimazolam
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Natsumi |
| Middle name | |
| Last name | Maeda |
Organization
Osaka Metropolitan University
Division name
Department of Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka, Osaka
TEL
0666453811
natsu-0724@omu.ac.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Maeda |
Organization
Osaka Metropolitan University
Division name
Department of Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka, Osaka
TEL
0666453811
Homepage URL
natsu-0724@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Institutional Review Board (IRB), Osaka Metropolitan University Hospital
Address
1-2-7, Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.jp
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
| 2025 | Year | 11 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will investigate real-world use of the novel sedative remimazolam in upper gastrointestinal endoscopy, focusing on recovery room stay and recovery time, the incidence of intra- and post-procedural complications, patient satisfaction, and symptoms or impacts on daily life up to the day after the procedure. We will also exploratorily assess the relationships between these outcomes and patients' baseline characteristics and the administered dose of the sedative.
Management information
Registered date
| 2025 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068366
