UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025556 |
|---|---|
| Receipt number | 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 | 2019/11/05 16:22:26 |
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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
iamkeikooo@gmail.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Murata |
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
nmurata.0210@gmail.com
Sponsor or person
Institute
The Nippon Dental University, School of Life Dentistry at Tokyo
Institute
Department
Personal name
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
nmurata.0210@gmail.com
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 | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.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 |
