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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025556
Receipt No. R000029414
Scientific Title The Study about the awakening time in continuous intravenous midazolam
Date of disclosure of the study information 2017/01/10
Last modified on 2019/07/10

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Basic information
Public title The Study about the awakening time in continuous intravenous midazolam
Acronym The Study about the awakening time in continuous intravenous midazolam
Scientific Title The Study about the awakening time in continuous intravenous midazolam
Scientific Title:Acronym The Study about the awakening time in continuous intravenous midazolam
Region
Japan

Condition
Condition Caries, teeth loss
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is intended to observe anesthesia awakening time and return permission time for the patient in dental treatment under intravenous sedation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes return permission time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 continuous intravenous midazolam
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria patients of ASA1 or ASA2 scheduled for dental treatment at NDU hospital
Key exclusion criteria 1. Patients commonly used psychotropic drugs, anti-psychotic drugs and sleeping pills
2. Obesity
3. Patients administered before surgery the sedative
4. Patients having history of drug allergy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Katsuhisa
Middle name
Last name Sunada
Organization The Nippon Dental University, School of Life Dentistry at Tokyo
Division name Department of Dental Anesthesiology
Zip code 102-8159
Address 1-9-20 Fujimi Chiyoda-ku, Tokyo 102-8159, Japan
TEL 03-3261-6560
Email iamkeikooo@gmail.com

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Morimoto
Organization The Nippon Dental University, School of Life Dentistry at Tokyo
Division name Department of Dental Anesthesiology
Zip code 102-8159
Address 1-9-20 Fujimi Chiyoda-ku, Tokyo 102-8159, Japan
TEL 03-3261-6560
Homepage URL
Email iamkeikooo@gmail.com

Sponsor
Institute The Nippon Dental University, School of Life Dentistry at Tokyo
Institute
Department

Funding Source
Organization The Nippon Dental University, School of Life Dentistry at Tokyo
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 Institutional ethics committee of The Nippon Dental University, School of Life Dentistry at Tokyo
Address 1-9-20Fujimi, chiyodaku, tokyo
Tel 03-3261-8311
Email iamkeiko@tky.ndu.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
2017 Year 01 Month 10 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
2016 Year 09 Month 29 Day
Date of IRB
2016 Year 10 Month 25 Day
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
2020 Year 12 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 01 Month 06 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029414

Research Plan
Registered date File name
2017/07/07 倫理審査申請書 0824 修正前.doc

Research case data specifications
Registered date File name
2017/07/07 別紙2 修正前.docx

Research case data
Registered date File name


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