UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000034348