UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061833 |
|---|---|
| Receipt number | R000070670 |
| Scientific Title | Impact of Changing Standard Sedation Agents on Patient Satisfaction in Endoscopic Procedures: A Comparative Study of Remimazolam and Midazolam Using an Interrupted Time Series Design |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/08 18:07:15 |
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Basic information
Public title
Impact of Changing Standard Sedation Agents on Patient Satisfaction in Endoscopic Procedures: A Comparative Study of Remimazolam and Midazolam Using an Interrupted Time Series Design
Acronym
REMI-SATIS
Scientific Title
Impact of Changing Standard Sedation Agents on Patient Satisfaction in Endoscopic Procedures: A Comparative Study of Remimazolam and Midazolam Using an Interrupted Time Series Design
Scientific Title:Acronym
REMI-SATIS
Region
| Japan |
Condition
Condition
digestive tract disorder
Classification by specialty
| Gastroenterology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes in patient satisfaction resulting from changing the standard drug for endoscopic sedation from midazolam to remimazolam.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average values for the following patient satisfaction items 1-6.
(5-point scale: 1: Very dissatisfied, 2: Dissatisfied, 3: Neutral, 4: Satisfied, 5: Very satisfied)
1.Time from the start of drug administration to the onset of sedation
2.Satisfaction with the reduction of discomfort during the examination
3.Depth of sedation during the examination
4.Time spent awake after the examination
5.Would you like to use this drug again?
6.Amnesia during endoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Phase 1 (Pre-intervention / Midazolam use period)
Duration: 3 weeks x 2 cycles (total 6 weeks)
Target number: 50 patients
Content: Midazolam will be used as the standard sedative, and data from consecutive cases will be collected as much as possible. The administration method will follow the package insert.
2. Phase 2 (Washout / Training Period)
Duration: 1 week x 2 cycles (total 2 weeks)
Content: Switching medications. Educating staff and familiarizing them with the administration rhythm. Data from this period will be excluded from the primary analysis.
3. Phase 3 (Post-intervention / Remimazolam use period)
Duration: 3 weeks x 2 cycles (total 6 weeks)
Target number: 50 patients
Content: Remimazolam will be used as the standard sedative, and data from consecutive cases will be collected as much as possible. The administration method will follow the package insert.
Two cycles are planned for each phase, but if the target number of patients (described below) is not reached, up to four cycles will be permitted. However, five or more cycles will not be performed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for elective upper gastrointestinal endoscopy (screening) or colonoscopy (screening or cold polypectomy; CSP)
1. Men and women aged 20 years or older
2. Patients with an American Society of Anesthesiologists (ASA) preoperative condition classification of Class I to II
3. Patients who have given written informed consent to participate in this study
Key exclusion criteria
1. Patients with a history of hypersensitivity to benzodiazepine drugs.
2. Patients with severe hepatic impairment (Child-Pugh class C) or those requiring dialysis.
3. Patients with ASA classification III or higher.
4. Patients with drug dependence, organic brain damage, or diseases related to upper airway obstruction (e.g., severe obesity, micrognathia, tonsillar hypertrophy, sleep apnea syndrome).
5. Pregnant, breastfeeding, or potentially pregnant women.
6. Patients requiring emergency endoscopy.
7. Patients scheduled for procedures requiring hospitalization, such as endoscopic mucosal resection (EMR).
8. Other patients deemed unsuitable as research subjects by the attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YOSHIDA |
| Middle name | |
| Last name | MAKOTO |
Organization
National Hospital Organization Hokkaido Cancer Center
Division name
Gastroenterology
Zip code
003-0804
Address
3-54 Kikusui 4-jo 2-chome, Shiroishi-ku, Sapporo-shi, Hokkaido 003-0804, Japan
TEL
0118119111
yoshimako10@gmail.com
Public contact
Name of contact person
| 1st name | UESUGI |
| Middle name | |
| Last name | ATSUSHI |
Organization
National Hospital Organization Hokkaido Cancer Center
Division name
Gastroenterology
Zip code
003-0804
Address
3-54 Kikusui 4-jo 2-chome, Shiroishi-ku, Sapporo-shi, Hokkaido 003-0804, Japan
TEL
0118119111
Homepage URL
uesugi.atsushi.ke@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Hokkaido Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Hokkaido Cancer 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
Ethics Review Committee, Hokkaido Cancer Center, National Hospital Organization
Address
3-54 Kikusui 4-jo 2-chome, Shiroishi-ku, Sapporo-shi, Hokkaido 003-0804, Japan
Tel
0118119111
yamamoto.ryojiro.pd@mail.hosp.go.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
| 2026 | Year | 06 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070670
