UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051953 |
|---|---|
| Receipt number | R000059291 |
| Scientific Title | Evaluation of the usefulness of the protocol for deep sedation for prostate biopsy in the Department of Anesthesiology, Showa University Northern Yokohama Hospital. |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2023/08/20 09:33:21 |
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Basic information
Public title
Evaluation of the usefulness of the protocol for deep sedation for prostate biopsy in the Department of Anesthesiology, Showa University Northern Yokohama Hospital.
Acronym
Evaluation of the usefulness of the protocol for deep sedation for prostate biopsy in the Department of Anesthesiology, Showa University Northern Yokohama Hospital.
Scientific Title
Evaluation of the usefulness of the protocol for deep sedation for prostate biopsy in the Department of Anesthesiology, Showa University Northern Yokohama Hospital.
Scientific Title:Acronym
Evaluation of the usefulness of the protocol for deep sedation for prostate biopsy in the Department of Anesthesiology, Showa University Northern Yokohama Hospital.
Region
| Japan |
Condition
Condition
Sedation for prostate biopsy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Deep sedation often carries the risk of airway obstruction. Furthermore, airway management is often performed by a physician in another department, rather than by an anesthesiologist who routinely performs airway management. Since April 2020, our anesthesiology department has developed a protocol for deep sedation for prostate biopsy regarding preoperative sedation risk assessment, airway management, and sedation drug administration. In this study, we will investigate the frequency of intraoperative and postoperative complications in relation to the preoperative risk assessment and discuss future issues to improve the safety of sedation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
airway management during sedation
Key secondary outcomes
Patient's background and risk factors
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
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
Patients undergoing prostate biopsy with deep sedation
Key exclusion criteria
Patients who do not mention information about snoring or sleep apnea
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | YAMAMURA |
| Middle name | |
| Last name | AYA |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
ayayamamura128@gmail.com
Public contact
Name of contact person
| 1st name | AYA |
| Middle name | |
| Last name | YAMAMURA |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
Homepage URL
ayayamamura128@gmail.com
Sponsor or person
Institute
Showa University
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-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
| 2023 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
52
Results
Results were presented at the 47th Annual Meeting of Japanese Society of Sleep Research 2022 in KYOTO
Results date posted
| 2023 | Year | 08 | Month | 20 | Day |
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
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Results were presented at the 47th Annual Meeting of Japanese Society of Sleep Research 2022 in KYOTO
Management information
Registered date
| 2023 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059291
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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