UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062607 |
|---|---|
| Receipt number | R000071666 |
| Scientific Title | Exploratory Analysis Factors Influencing Optimal Bispectral Index Values During Gastrointestinal Endoscopic Sedation |
| Date of disclosure of the study information | 2026/08/18 |
| Last modified on | 2026/08/18 20:57:47 |
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Basic information
Public title
Exploratory Analysis of Factors Influencing Optimal Bispectral Index Values During Gastrointestinal Endoscopic Sedation (BEST study)
Acronym
Bispectral index during gastrointestinal Endoscopic SedaTion
Scientific Title
Exploratory Analysis Factors Influencing Optimal Bispectral Index Values During Gastrointestinal Endoscopic Sedation
Scientific Title:Acronym
Bispectral Index Evaluation during Gastrointestinal Endoscopic SedaTion
Region
| Japan |
Condition
Condition
Patients with suspected gastrointestinal disease who undergo esophagogastroduodenoscopy or colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using Bispectral Index (BIS) monitoring, this study aims to identify factors associated with optimal BIS values during gastrointestinal endoscopic sedation and to determine age-specific optimal BIS values.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploratory Analysis of Factors Influencing BIS Values
Key secondary outcomes
Correlations between age, BIS values, and sedation assessment scales (MOAA/S and Ramsay score); median and optimal BIS values according to age group; safety outcomes (respiratory depression, body movement, hypotension, bradycardia, perforation, bleeding, and pneumonia); sedative and analgesic doses (remimazolam, midazolam, and pethidine); procedure time; patient and endoscopist satisfaction (Likert scale); recovery assessed by the Aldrete score; interval and frequency of additional drug administration; time from initial administration to procedure initiation; procedure completion rate; and procedure interruption rate due to patient movement.
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
Age.>18 years.
Scheduled for sedated upper gastrointestinal endoscopy.
Scheduled for sedated lower gastrointestinal endoscopy.
Key exclusion criteria
Performance Status>3.
Patients with severe cardiac dysfunction(New York Heart Association Classlll or higher),pulmonary dysfunction requiring continuous of intermittent oxygen therapy,hepatic dysfunction(Child-Pugh Class C),renal dysfunction(eGFR<30mL/min/1.73m2),or uncontrolled diabetes mellitus(HbA1c>9.0%).
Patients with glaucoma,myasthenia gravis,or alcohol intoxication/alcohol dependence.
Patients with psychiatric disorders or dementia who are considered unable to participate in the study.
Patients judged by the investigateor to be inappropriate for patricipation in the study for any reason.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Gastroenterology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561623311
mebi@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Gastroenterology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561623311
Homepage URL
mebi@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical University
Institute
Department
Personal name
Satoshi Ono
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi medical university
Address
1-1 Yazakokarimata, Nagakute, Aichi
Tel
0561623311
mebi@aichi-med-u.ac.jjp
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 | 08 | Month | 18 | 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
| 2026 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071666
