UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036530 |
|---|---|
| Receipt number | R000041615 |
| Scientific Title | Management of intravenous sedation for the elderly patients with progressed dementia during dental treatment- a comparison between midazolam and dexmedetomidine |
| Date of disclosure of the study information | 2019/04/16 |
| Last modified on | 2019/09/07 09:18:17 |
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Basic information
Public title
Management of intravenous sedation for the elderly patients with progressed dementia during dental treatment- a comparison between midazolam and dexmedetomidine
Acronym
Intravenous sedation for the progressed dementia
Scientific Title
Management of intravenous sedation for the elderly patients with progressed dementia during dental treatment- a comparison between midazolam and dexmedetomidine
Scientific Title:Acronym
Intravenous sedation for the progressed dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Anesthesiology |
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are no studies of the behavior management using intravenous sedation for the elderly dementia patients suggesting severe refusal. The objectives of this study is to establish the management methods without deterioration of cognitive function in the dental settings that the repetitive treatments are necessary. In this study, a comparison between midazolam and dexmedetomidine is performed.
Basic objectives2
Others
Basic objectives -Others
The comparison of the cognitive and swallowing function between pre- and post-sedation in the elderly dementia patients are performed. In addition to this, cerebral blood flow, electroencephalogram, nutrition and body composition analysis are used to evaluate the risk of postoperative cognitive dysfunction and dysphagea between anesthesia methods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The cerabral blood flow and EEG during intravenous sedation
Key secondary outcomes
The cognitive function and swallowing function at pre- and post-sedation
The nutrition and body composition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
midazolam
Interventions/Control_2
dexmedetomidine
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
with dementia
>=60 years old
Key exclusion criteria
without dementia
<60 years old
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Morimoto |
Organization
Graduate School of Dentistry, Kanagawa Dental University
Division name
Department of Critical Care Medicine and Dentistry
Zip code
2388580
Address
82, Inaoka-cho, Yokosuka, kanagawa, 238-8580, Japan
TEL
+819059605429
morimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinari |
| Middle name | |
| Last name | Morimoto |
Organization
Graduate School of Dentistry, Kanagawa Dental University
Division name
Department of Critical Care Medicine and Dentistry
Zip code
2388580
Address
82, Inaoka-cho, Yokosuka, kanagawa, 238-8580, Japan
TEL
+819059605429
Homepage URL
morimoto@kdu.ac.jp
Sponsor or person
Institute
Department of Critical Care Medicine and Dentistry, Graduate School of Dentistry, Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Critical Care Medicine and Dentistry, Graduate School of Dentistry, Kanagawa Dental University
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
Kanagawa Dental University
Address
82, Inaoka-cho, Yokosuka, kanagawa, Japan
Tel
+819059605429
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 16 | 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
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 16 | Day |
Last modified on
| 2019 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041615
