UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061099 |
|---|---|
| Receipt number | R000068201 |
| Scientific Title | Comparison of Sedation Outcomes and Discharge Criteria Between Remimazolam and Flunitrazepam in Outpatient Gastrointestinal Endoscopy: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/03/30 |
| Last modified on | 2026/03/29 18:36:24 |
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Basic information
Public title
Comparison of Sedation Outcomes and Discharge Criteria Between Remimazolam and Flunitrazepam in Outpatient Gastrointestinal Endoscopy: A Prospective Observational Study
Acronym
Remimazolam vs flunitrazepam for sedation in outpatient gastrointestinal endoscopy: time to discharge based on standardized discharge criteria (prospective observational study)
Scientific Title
Comparison of Sedation Outcomes and Discharge Criteria Between Remimazolam and Flunitrazepam in Outpatient Gastrointestinal Endoscopy: A Prospective Observational Study
Scientific Title:Acronym
Remimazolam vs flunitrazepam for sedation in outpatient gastrointestinal endoscopy: time to discharge based on standardized discharge criteria (prospective observational study)
Region
| Japan |
Condition
Condition
Gastrointestinal diseases requiring upper or lower endoscopy (e.g., gastroesophageal reflux disease, atrophic gastritis, gastric cancer, colorectal cancer, colorectal polyps)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the novel sedative remimazolam for outpatient gastrointestinal endoscopy, with a focus on recovery time and discharge readiness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time (minutes) from end of endoscopy to discharge readiness (first attainment of PADSS>9/10)
Key secondary outcomes
Compare sedation drug use and the frequency of sedation-related adverse events (SBP <90 mmHg,SpO2 <90%, HR <50 bpm, oxygen supplementation), including whether interventions were required.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive participants aged >= 18 years undergoing upper gastrointestinal endoscopy (EGD) or colonoscopy (CS) under sedation at our clinic who provide written informed consent to this study.
Key exclusion criteria
Known allergy or hypersensitivity to the study drugs
Poor general condition classified as ASA Physical Status Class IV or V
Pregnancy or breastfeeding
Severe COPD or obstructive sleep apnea; severe hepatic impairment (e.g., Child-Pugh C); chronic benzodiazepine use or tolerance; severe renal impairment (eGFR < 30 mL/min/1.73 m^2)
Unable or unwilling to provide written informed consent to this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Imagawa |
Organization
Imagawa Medical Clinic
Division name
Gastroenterology
Zip code
769-1503
Address
285-3, Takeda, Kasada, Toyonaka, Mitoyo-city, Kagawa, Japan
TEL
+81-875-62-2052
imagawa-gi@nifty.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Imagawa |
Organization
Imagawa Medical Clinic
Division name
Gastroenterology
Zip code
769-1503
Address
285-3, Takeda, Kasada, Toyonaka, Mitoyo-city, Kagawa, Japan
TEL
+81-875-62-2052
Homepage URL
imagawa-gi@nifty.com
Sponsor or person
Institute
Imagawa Medical Clinic
Institute
Department
Personal name
Atsushi Imagawa
Funding Source
Organization
Imagawa Medical Clinic
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
Kagawa Medical Association
Address
73-4 Hamano-cho, Takamatsu, Kagawa, Japan
Tel
+81-87-823-0155
kma@kagawa.med.or.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 | 03 | Month | 30 | 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
| 2025 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients were divided into a flunitrazepam group (F group first 70 consecutive cases) and a remimazolam group (R group subsequent 70 consecutive cases). Conscious sedation was performed, defined as a state in which the patient responds to stimuli while maintaining spontaneous respiration and airway patency. The depth of sedation was assessed using the Ramsay Sedation Scale (levels 1-6), with level 4 (asleep but with a brisk response to a light glabellar tap or loud auditory stimulus) as the target level. In elderly patients and those with low body weight, the initial dose was reduced to half of the standard dose. When patients had a previous history of sedation at our institution, the previously effective dose was used as a reference. Additional doses were administered as needed according to the depth of sedation and sedative effect, mainly judged by the presence of body movement.
Management information
Registered date
| 2026 | Year | 03 | Month | 29 | Day |
Last modified on
| 2026 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068201
