UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060378 |
|---|---|
| Receipt number | R000069066 |
| Scientific Title | A Prospective Comparative Study of the Sedative Efficacy and Safety of Remimazolam (Anerem) versus Midazolam in Endoscopic Submucosal Dissection |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/16 14:36:54 |
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Basic information
Public title
A Comparative Study of the Sedative Effects and Safety of Anerem (Remimazolam) and Midazolam in Endoscopic Submucosal Dissection (ESD)
Acronym
ESD Sedation Comparison Study (Remimazolam vs Midazolam)
Scientific Title
A Prospective Comparative Study of the Sedative Efficacy and Safety of Remimazolam (Anerem) versus Midazolam in Endoscopic Submucosal Dissection
Scientific Title:Acronym
ESD-REMIMID Study
Region
| Japan |
Condition
Condition
Gastrointestinal neoplasms indicated for Endoscopic Submucosal Dissection (ESD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the field of gastrointestinal endoscopy, benzodiazepines are essential sedative agents for reducing patient discomfort and ensuring the safe performance of endoscopic procedures. In recent years, the short-acting benzodiazepine sedative Anerem (remimazolam) has been newly approved, and its indications in gastrointestinal endoscopic procedures have been expanding.
However, previous clinical studies have mainly focused on short-duration diagnostic or therapeutic procedures, and the clinical usefulness of remimazolam in prolonged and invasive procedures such as endoscopic submucosal dissection (ESD) has not been sufficiently evaluated. In particular, data regarding the stability of sedation, rapidity of recovery, safety, and their association with patient characteristics remain limited.
The aim of this study is to compare the clinical efficacy and safety of sedation with remimazolam and midazolam in patients undergoing ESD, and to elucidate the true pharmacological effects of these agents after adjusting for patient background factors, including alcohol consumption history, prior benzodiazepine use, and renal function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recovery from sedation (time from completion of ESD to full recovery of consciousness)
Key secondary outcomes
Time to induction of sedation (time from initiation of sedative administration to achievement of a Richmond Agitation-Sedation Scale (RASS) score of -2 to -3)
Stability of sedation (assessed using RASS and bispectral index (BIS) monitoring)
Completion rate of ESD (presence or absence of treatment interruption and successful resection)
Incidence of adverse events (including oxygen desaturation, hypotension, respiratory depression, and bradycardia)
Occurrence of paradoxical reactions
Physician, nurse, and patient satisfaction (assessed using a 5-point Likert scale questionnaire)
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In this study, patients undergoing endoscopic submucosal dissection (ESD) are assigned to one of the following two intervention groups for procedural sedation:
Remimazolam group:
Sedation is performed using remimazolam (Anerem).
Sedative agents are administered according to institutional standard protocols, and dosing is adjusted to maintain an appropriate level of sedation during the procedure.
Interventions/Control_2
In this study, patients undergoing endoscopic submucosal dissection (ESD) are assigned to one of the following two intervention groups for procedural sedation:
Midazolam group:
Sedation is performed using midazolam.
Sedative agents are administered according to institutional standard protocols, and dosing is adjusted to maintain an appropriate level of sedation during the procedure.
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. Age: 18 years or older
2. ASA Physical Status Classification: Class I or II
3. Patients scheduled to undergo endoscopic submucosal dissection (ESD) for early esophageal cancer, early gastric cancer, or colorectal neoplasms
4. Provision of written informed consent to participate in this study
Key exclusion criteria
1. Severe hepatic impairment (Child-Pugh class C) or severe renal failure (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2)
2. Pregnant or breastfeeding women
3. History of airway obstruction or severe respiratory disease
4. History of allergy or hypersensitivity to benzodiazepines
5. Regular use of other sedative agents, such as propofol
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tomioka |
Organization
Saitama Medical College International Medical Center
Division name
Department of Gastroenterology
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
+81-(42)-984-4111
a-tomioka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tomioka |
Organization
Saitama Medical College International Medical Center
Division name
Department of Gastroenterology
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
+81-(42)-984-4111
Homepage URL
a-tomioka@saitama-med.ac.jp
Sponsor or person
Institute
Akria Tomioka, Department of Gastroenterology, Saitama Medical College International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical College International Medical 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
Institutional Review Board for Clinical Research, Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel
+81-(42)-984-4111
imc_irb@saitama-med.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
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069066
