UMIN-ICDS 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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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