UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020857
Receipt number 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 20:48:54

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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 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

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

Value
https://center6.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