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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030088
Receipt No. R000034348
Scientific Title The study for the effect of light sedation using administration of dexmedetomidine on decrease of the value of pulse oximetry during dental procedure in young healthy patients and for the prophylaxis effect of oxygen inhalation on the sedation-induced desaturation
Date of disclosure of the study information 2018/03/31
Last modified on 2019/06/19

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Basic information
Public title The study for the effect of light sedation using administration of dexmedetomidine on decrease of the value of pulse oximetry during dental procedure in young healthy patients and for the prophylaxis effect of oxygen inhalation on the sedation-induced desaturation
Acronym Administration of dexmedetomidine and oxygen desaturation during detal procedure
Scientific Title The study for the effect of light sedation using administration of dexmedetomidine on decrease of the value of pulse oximetry during dental procedure in young healthy patients and for the prophylaxis effect of oxygen inhalation on the sedation-induced desaturation
Scientific Title:Acronym Administration of dexmedetomidine and oxygen desaturation during detal procedure
Region
Japan

Condition
Condition Horizontal third molar impaction
Classification by specialty
Anesthesiology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to clarify the effect of supplemental inhalation of oxygen preventing from desaturation during dental procedures.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The changes in the value of pulseoxymetry.
Key secondary outcomes The satisfaction of patients for the procedure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 No inhalation of oxygen
Interventions/Control_2 Low rate inhalation of oxygen using conventional nasal cannula
Interventions/Control_3 Oxygen inhalation using high flow nasal cannula system
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
40 years-old >=
Gender Male and Female
Key inclusion criteria Relatively health and young patients without apparent complications
Key exclusion criteria The patients who shows moderate and severe complications
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Saori
Middle name
Last name Tahararu
Organization Nagoya University Hospital
Division name Department of Anesthesiology
Zip code 4668550
Address 65 Tsurumai-cho, Showaku, Nagoya
TEL 0527442340
Email yuadachi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Yushi
Middle name
Last name Adachi
Organization Nagoya University Hospital
Division name Department of Surgical Intensive Care Medicine
Zip code 4668550
Address 65 Tsurumai-cho, Showaku, Nagoya
TEL 0527442340
Homepage URL
Email yuadachi@med.nagoya-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Nagoya University Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology, Nagoya University Hospital
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 Ethical Committee, Nagoya University Hospital
Address 65 Tsurumai-cho, Showa-ku, Nagoya
Tel 0527442340
Email ethics@med.nagoya-u.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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 22 Day
Date of IRB
2018 Year 04 Month 15 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2020 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
2017 Year 11 Month 22 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034348

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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