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Recruitment status Completed
Unique ID issued by UMIN UMIN000014144
Receipt No. R000016473
Official scientific title of the study 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

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Basic information
Official scientific title of the study Study on awaking from intravenous sedation -Analysis Using Wearable Type of Eye Movement Measuring Apparatus TalkEye Lite-
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Yuya Tomita
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Dental Anesthesiology
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL 0252671500
Email ytomita@ngt.ndu.ac.jp

Public contact
Name of contact person Yuya Tomita
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Dental Anesthesiology
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL 0252671500
Homepage URL
Email ytomita@ngt.ndu.ac.jp

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016473


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