UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042125 |
|---|---|
| Receipt number | R000046821 |
| Scientific Title | Observational study of bispectral index monitoring as an adjunct to dexmedetomidine deep sedation for endoscopic treatment |
| Date of disclosure of the study information | 2020/10/14 |
| Last modified on | 2024/10/17 09:16:13 |
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Basic information
Public title
Observational study of bispectral index monitoring as an adjunct to dexmedetomidine deep sedation for endoscopic treatment
Acronym
Observational study of bispectral index monitoring as an adjunct to dexmedetomidine deep sedation for endoscopic treatment
Scientific Title
Observational study of bispectral index monitoring as an adjunct to dexmedetomidine deep sedation for endoscopic treatment
Scientific Title:Acronym
Observational study of bispectral index monitoring as an adjunct to dexmedetomidine deep sedation for endoscopic treatment
Region
| Japan |
Condition
Condition
gastrointestinal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In case of endoscopic treatment for GI tumor, we evaluate the score of Bispectral Index System under the dexmedetomidine sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the score of Bispectral Index System between 4 to 6 in Ramsay sedation scale and -3 to -5 in Richmond Agitation-Sedation Scale under the dexmedetomidine sedation
Key secondary outcomes
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
patient undergoing endoscopic treatment for the gastrointesitinal tumor under the dexmedetomidine sedation
Key exclusion criteria
examinees who is considered ungrammaticaly by the endoscopists
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasutoshi |
| Middle name | |
| Last name | Ochiai |
Organization
St. Marianna University, School of Medicine Toyoko Hospital
Division name
Department of Gastroenterology
Zip code
211-0063
Address
3-435, Kosugimachi, Nakahara-ku, Kawasaki
TEL
0447222121
yasutoshi.ochiai@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasutoshi |
| Middle name | |
| Last name | Ochiai |
Organization
St. Marianna University, School of Medicine Toyoko Hospital
Division name
Department of Gastroenterology
Zip code
211-0063
Address
3-435, Kosugimachi, Nakahara-ku, Kawasaki
TEL
0447222121
Homepage URL
yasutoshi.ochiai@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University, School of Medicine Toyoko Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
St. Marianna University, School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel
0449778111
k-sienbu.mail@marianna-u.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
| 2020 | Year | 10 | Month | 14 | 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
| Delay expected |
Results Delay Reason
It is difficult to evaluate the results.
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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
To evaluate the score of Bispectral Index System between 4 to 5 in Ramsay sedation scale and -3 to -4 in Richmond Agitation-Sedation Scale under the dexmedetomidine sedation.
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046821
