UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030088
Receipt number 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 10:15:08

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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 or person

Institute

Department of Anesthesiology, Nagoya University Hospital

Institute

Department

Personal name



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

Value
https://center6.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