UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053500 |
|---|---|
| Receipt number | R000061062 |
| Scientific Title | Intervention Study on Sedation Depth Monitoring for Endoscopy and Surgery in Operating and Procedure Rooms |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2025/01/31 09:17:59 |
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Basic information
Public title
Intervention Study on Sedation Depth Monitoring for Endoscopy and Surgery in Operating and Procedure Rooms
Acronym
SDM Study (Sedation Depth Monitoring Study)
Scientific Title
Intervention Study on Sedation Depth Monitoring for Endoscopy and Surgery in Operating and Procedure Rooms
Scientific Title:Acronym
SDM Study (Sedation Depth Monitoring Study)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore appropriate management methods for moderate sedation in gastrointestinal endoscopy and general anesthesia in surgical operations.
Basic objectives2
Others
Basic objectives -Others
It evaluates patients' vital signs, brain waves, and the amount of medication used, pursuing effective methods of sedation and anesthesia. Additionally, it investigates the impact of the operating room environment (such as music) on the depth of sedation and anesthesia, and comprehensively evaluates factors contributing to postoperative delirium. Through this, the study seeks to explore potential improvements in sedation monitoring methods and the optimization of the operating and procedure room environment, aiming to achieve better sedation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The impact of auditory stimulation on sedation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Intervention through music
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
1) Patients at National Cancer Center Hospital East, undergoing gastrointestinal endoscopy (examination/treatment) under moderate sedation, or undergoing surgery under general anesthesia.
2) Individuals who are aged 20 years or older at the time of consent acquisition.
3) Patients who have provided written consent for participation in this study."
Key exclusion criteria
1) Patients with hearing impairment (cases where the response to auditory stimuli was insufficient during the operational check of the earphone-type electroencephalogram device).
2) Individuals deemed inappropriate by the research director for any reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Yano |
Organization
National Cancer Center Hospital East
Division name
Department of gastroenterology and endoscopy
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-City, Chiba, Japan
TEL
04-7133-1111
toyano@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Watanabe |
Organization
National Cancer Center Hospital East
Division name
Department of gastroenterology and endoscopy
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-City, Chiba, Japan
TEL
04-7133-1111
Homepage URL
takaswat@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
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
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa-City, Chiba, Japan
Tel
04-7133-1111
irst@ml.res.ncc.go.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
| 2024 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061062
