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
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
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
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
