UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049731 |
|---|---|
| Receipt number | R000056637 |
| Scientific Title | Validity of Oxygen Administration in Intravenous Sedation in Dentistry Using Oxygenation Reserve (ORi) as an Index |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2022/12/08 15:49:09 |
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Basic information
Public title
Validity of Oxygen Administration in Intravenous Sedation in Dentistry Using Oxygenation Reserve (ORi) as an Index
Acronym
Validity of Oxygen Administration in Intravenous Sedation in Dentistry Using Oxygenation Reserve (ORi) as an Index
Scientific Title
Validity of Oxygen Administration in Intravenous Sedation in Dentistry Using Oxygenation Reserve (ORi) as an Index
Scientific Title:Acronym
Validity of Oxygen Administration in Intravenous Sedation in Dentistry Using Oxygenation Reserve (ORi) as an Index
Region
| Japan |
Condition
Condition
Dental disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During sedation, oxygen is administered at a rate of 3 L to 5 L/min to prevent pulse oximetry and drug-induced desaturation. Because the oral cavity is the operative field in dentistry, the use of a neosurgical cannula is commonly used for oxygen administration, which may result in inadequate oxygen administration or ineffective administration routes. In this study, we will evaluate the appropriate oxygen dosage and the appropriateness of oxygen administration during sedation in the dental field by applying ORi and SpO2 monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORi
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone surgical dental procedures at Showa University Dental Hospital and Showa University Northern Yokohama Hospital and are at least 20 years of age.
American Society of Anesthesiologists physical status1or2
Key exclusion criteria
Patients with contraindications to propofolor/and midazolam.
Patients deemed by the principal investigator and principal investigator to be appropriate for non-participation in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | MEGURU |
| Middle name | |
| Last name | YAMADA |
Organization
SHOWA University
Division name
Department of Perioperative Medicine, Division of Anesthesiology
Zip code
145-8515
Address
2-1-1,Kitasenzoku,Oota-ku,Tokyo,Japan
TEL
03-3787-1151
meyamada@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Meguru |
| Middle name | |
| Last name | Yamada |
Organization
SHOWA University
Division name
Department of Perioperative Medicine, Division of Anesthesiology
Zip code
145-8515
Address
2-1-1,Kitasenzoku,Oota-ku,Tokyo,Japan
TEL
03-3787-1151
Homepage URL
meyamada@dent.showa-u.ac.jp
Sponsor or person
Institute
SHOWA University
Institute
Department
Personal name
Funding Source
Organization
SHOWA University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8,Hatanodai,Shinagawa-ku,Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 08 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2022 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056637
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
