UMIN-CTR Clinical Trial

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
Email	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
Email	meyamada@dent.showa-u.ac.jp

Sponsor
Institute	SHOWA University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056637