UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043454 |
|---|---|
| Receipt number | R000049625 |
| Scientific Title | Study of intravenous sedation for elderly patients with severe dementia during dental treatment-comparison with healthy subjects by EEG analysis |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/08/02 20:01:02 |
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Basic information
Public title
Study of intravenous sedation for elderly patients with severe dementia during dental treatment-comparison with healthy subjects by EEG analysis
Acronym
Study of intravenous sedation for elderly patients with severe dementia
Scientific Title
Study of intravenous sedation for elderly patients with severe dementia during dental treatment-comparison with healthy subjects by EEG analysis
Scientific Title:Acronym
Study of intravenous sedation for elderly patients with severe dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Anesthesiology | Oral surgery |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the intravenous sedation using midazolam during dental treatment, the intraoperative cerebral blood flow and EEG are measured and compared with between elderly patients with/ without cognitive impairment.
Basic objectives2
Others
Basic objectives -Others
The postoperative cognitive and swallowing declines are evaluated in the elderly patients with severe dementia.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
encephalography; measurement during midazolam administration
Key secondary outcomes
cerebral blood flow; measurement during midazolam administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous sedation with midazolam for the elderly patients with severe dementia
Interventions/Control_2
Intravenous sedation with midazolam for the elderly patients without cognitive impairment
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The elderly patients with severe dementia
Key exclusion criteria
The elderly patients without cognitive impairment
The patients who could not use midazolam for allergy or narrow-angle glaucoma
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Morimoto |
Organization
Kanagawa Dental University
Division name
Division of Geriatric Dentistry, Department of Critical Care Dentistry
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL
046-845-3168
morimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinari |
| Middle name | |
| Last name | Morimoto |
Organization
Kanagawa Dental University
Division name
Division of Geriatric Dentistry, Department of Critical Care Dentistry
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
TEL
046-845-3168
Homepage URL
morimoto@kdu.ac.jp
Sponsor or person
Institute
Division of Geriatric Dentistry, Department of Critical Care Dentistry, Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan
Tel
046-845-3168
morimoto@kdu.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
神奈川歯科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049625
