UMIN-CTR Clinical Trial

Basic information
Public title	Development of robot sedation system
Acronym	Development of robot sedation system
Scientific Title	Development of robot sedation system
Scientific Title:Acronym	Development of robot sedation system
Region	Japan

Condition
Condition	Adult patient undergoing dental treatment under intravenous sedation
Classification by specialty	Anesthesiology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Applying the machine learning function of artificial intelligence to build a robot sedation system for intravenous sedation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a) Patient information (height, weight, age, complications) b) Vital signs (mean blood pressure, heart rate, SpO2, EtCO2, body temperature, BIS value) c) Dosage of various anesthetics (propofol, midazolam, fentanyl)
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with dental procedures managed under intravenous sedation
Key exclusion criteria	(1) Patients under 20 years old (2) Patients with serious complications before surgery (3) Patients with serious complications
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Hoshijima
Organization	Tohoku University Graduate School of Dentistry
Division name	Dento-oral Anesthesiology
Zip code	980-8575
Address	Seiryomachi 4-1, Aoba, Sendai, Miyagi
TEL	022-717-8420
Email	hiroshi.hoshijima.d1@tohoku.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Hoshijima
Organization	Tohoku University Graduate School of Dentistry
Division name	Dento-oral Anesthesiology
Zip code	980-8575
Address	Seiryomachi 4-1, Aoba, Sendai, Miyagi
TEL	09065018786
Homepage URL
Email	hhoshi6@gmail.com

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Tohoku University Graduate School of Dentistry
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	Tohoku University Graduate School of Dentistry
Address	Seiryomachi 4-1, Aoba, Sendai, Miyagi
Tel	022-717-8420
Email	hiroshi.hoshijima.d1@tohoku.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	2023 Year 01 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2026 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Personal information will be separated from the data used, and will be managed and implemented so that personal information will not be leaked. When publishing the results of the study, do not include information that can identify the subject. In addition, patient information obtained in the study will not be used for purposes other than the purpose of the study. The obtained information will not be disclosed to the outside, and data analysis will be carried out within the research target organization. Personal information will be discarded after the research is completed.

Management information
Registered date	2022 Year 05 Month 12 Day
Last modified on	2022 Year 05 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054421