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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036530
Receipt No. 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

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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
Email 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
Email morimoto@kdu.ac.jp

Sponsor
Institute Department of Critical Care Medicine and Dentistry, Graduate School of Dentistry, Kanagawa Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041615

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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