UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056959 |
|---|---|
| Receipt number | R000065094 |
| Scientific Title | Retrospective observational study of sedation during gastrointestinal endoscopy |
| Date of disclosure of the study information | 2025/02/06 |
| Last modified on | 2026/10/23 10:13:49 |
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Basic information
Public title
Retrospective observational study of sedation during gastrointestinal endoscopy
Acronym
R-SDG
Scientific Title
Retrospective observational study of sedation during gastrointestinal endoscopy
Scientific Title:Acronym
R-SDG
Region
| Japan |
Condition
Condition
Patients who underwent upper gastrointestinal endoscopy or colonoscopy at Keio University Hospital
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of sedation during gastrointestinal endoscopy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of adverse events (decrease in blood pressure, pulse rate, and SpO2) that occurred during sedation for gastrointestinal endoscopy
Key secondary outcomes
(1) Presence/absence, type, and dosage of sedative medication during gastrointestinal endoscopy, antagonist (flumazenil) administration, and analgesic administration
(2) Treatment (infusion of fluids, oxygen administration) for adverse events (decrease in blood pressure, decrease in heart rate, decrease in SpO2)
(3) Falls in the hospital or on the way home
(4) Length of stay in the recovery room
(5) Patient's age, gender, underlying disease, medical history, and medications
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent esophagogastroduodenoscopy or colonoscopy at Keio University Hospital
Key exclusion criteria
Cases in which there are obvious deficiencies in the content related to sedation and medical information such as vital signs before, during, and after gastrointestinal endoscopy.
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakayama |
Organization
Keio University Hospital
Division name
Cancer Center
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
anakayama34@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mundipharma
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 committee of Keio university school of medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-ft_pt@adst.keio.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 | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8037
Results
A total of 3,797 patients were included. The median total dose was 3 mg (IQR, 3-5). The incidence of cardiorespiratory depression was 4.9%. 55.5% of patients were discharged from the recovery unit within 30 minutes. Older age and female sex were identified as risk factors for cardiorespiratory depression, and female sex was additionally associated with prolonged recovery room stay.
Results date posted
| 2026 | Year | 10 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted a retrospective observational study of outpatients aged 20 years or older who underwent upper or lower gastrointestinal routine endoscopy between January 2025 and June 2025. Remimazolam was introduced into clinical practice at our institution in November 2022. In January 2025, sedation with remimazolam was adopted for routine endoscopic sedation.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | 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
None
Management information
Registered date
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065094
