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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020857
Receipt No. R000024070
Scientific Title Study on the arousal judgment of midazolam use intravenous sedation using the wearable eye movement apparatus TaikEye Lite -Part 2 Effects of flumazenil-
Date of disclosure of the study information 2016/02/05
Last modified on 2020/02/05

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Basic information
Public title Study on the arousal judgment of midazolam use intravenous sedation using the wearable eye movement apparatus TaikEye Lite
-Part 2 Effects of flumazenil-
Acronym Study on awakening judgment at the time of antagonist combination of intravenous sedation
Scientific Title Study on the arousal judgment of midazolam use intravenous sedation using the wearable eye movement apparatus TaikEye Lite
-Part 2 Effects of flumazenil-
Scientific Title:Acronym Study on awakening judgment at the time of antagonist combination of intravenous sedation
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Performs arousal determination using the eye movement measuring apparatus when Antagonists used under sedation, is conducted for the purpose of consideration of the criteria of determination go home.
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 findings
5,Sedation score
6,Vital signs
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Midazolam 0.05mg/kg was administered intravenously, and then 2mg administered flumazenil.
Interventions/Control_2 Midazolam 0.05mg/kg was administered intravenously, and then administering a full saline.
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 infprmed concent from all subjects.
Key exclusion criteria Patient of two deggree or more of ASAclassification
Age of under 20
Have a drug Allergy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yosihide
Middle name
Last name Saitou
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Dental Anesthesiology
Zip code 951-8580
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL 0252671500
Email sai10yo@ngt.ndu.ac.jp

Public contact
Name of contact person
1st name Yosihide
Middle name
Last name Saitou
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Dental Anesthesiology
Zip code 951-8580
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL 0252671500
Homepage URL
Email sai10yo@ngt.ndu.ac.jp

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

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 The Nippon Dental University School of Life Dentistry at Niigata
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
Tel 025-267-1500
Email sai10yo@ngt.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
2016 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 40
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
2016 Year 02 Month 03 Day
Date of IRB
2016 Year 04 Month 11 Day
Anticipated trial start date
2016 Year 02 Month 05 Day
Last follow-up date
2019 Year 03 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
2016 Year 02 Month 03 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024070

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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