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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042451
Receipt No. R000048459
Scientific Title Evaluation of sedation level by using SedLine during intravenous sedation for dental treatment
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/13

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Basic information
Public title Evaluation of sedation level by using SedLine during intravenous sedation for dental treatment
Acronym Evaluation of sedation level by using SedLine
Scientific Title Evaluation of sedation level by using SedLine during intravenous sedation for dental treatment
Scientific Title:Acronym Evaluation of sedation level by using SedLine
Region
Japan

Condition
Condition Dental Caries, periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the suitable Patient State Index in intravenous sedation for dental treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient State Index at the start of dental treatment.
Key secondary outcomes 1)Average Patient State Index during dental treatment.
2)The estimated propofol concentration in target controlled infusion at the start of dental treatment.
3)Blood pressure, heart rate, and oxygen saturation during sedation.
4)Total amount of midazolam and propofol for sedation.
5)Amnesia during dental treatment.
6)Satisfaction with sedation.

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 1)Patients whose age is over 20 years.
2)Patients whose American Society of Anesthesiology physical state(ASA PS) is 1 or 2.
Key exclusion criteria 1)Patients who needed management by deep sedation.
2)Patients who taking centrally acting drugs, such as anti-epileptic drugs and/or antipsychotic drugs.
3)Patients who are contraindicated for the use of midazolam or propofol.
4)Patients who are judged to be inappropriate for study participation.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Higuchi
Organization Okayama University Hospital
Division name Department of Dental Anesthesiology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan
TEL 086-235-6721
Email higuti@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Higuchi
Organization Okayama University Hospital
Division name Department of Dental Anesthesiology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan
TEL 086-235-6721
Homepage URL
Email higuti@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Okayama 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 The Ethics Committee of Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel 086-235-6938
Email mae6605@adm.okayama-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
2020 Year 11 Month 16 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
2020 Year 08 Month 05 Day
Date of IRB
2020 Year 08 Month 14 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 11 Month 13 Day
Last modified on
2020 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048459

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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