UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014144 |
|---|---|
| Receipt number | R000016473 |
| Scientific Title | Study on awaking from intravenous sedation -Analysis Using Wearable Type of Eye Movement Measuring Apparatus TalkEye Lite- |
| Date of disclosure of the study information | 2014/06/20 |
| Last modified on | 2015/04/30 13:51:04 |
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Basic information
Public title
Study on awaking from intravenous sedation -Analysis Using Wearable Type of Eye Movement Measuring Apparatus TalkEye Lite-
Acronym
Study on awaking from intravenous sedation
Scientific Title
Study on awaking from intravenous sedation -Analysis Using Wearable Type of Eye Movement Measuring Apparatus TalkEye Lite-
Scientific Title:Acronym
Study on awaking from intravenous sedation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is evaluation of recovery after intravenous sedation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Eye movement
2.Romberg's test
3.Electroencephalogram
4.Clinical presentation
5.Sedation score
6.Vital sign
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Intravenous sedation involved a single administration of 0.05mg/kg 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The healty adult male and female volunteers participated this study. We obtained informed concent from all subjects
Key exclusion criteria
Patient of two degree or more of ASAclassification
Age of under 20
Have a drug Allergy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuya Tomita |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
0252671500
ytomita@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuya Tomita |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
0252671500
Homepage URL
ytomita@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 02 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016473
