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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041782
Receipt No. R000047689
Scientific Title The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Date of disclosure of the study information 2020/09/14
Last modified on 2020/09/14

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Basic information
Public title The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Acronym The relationship between a depth of anesthesia and administration of Remimazolam
Scientific Title The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Scientific Title:Acronym The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to verify the relationship between a depth of anesthesia and administration of Remimazolam
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time of loss of consciousness
Key secondary outcomes EEG changes by an administration of Remimazolam

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >=
Gender Male and Female
Key inclusion criteria ASA1-2
elective surgery
Key exclusion criteria weight<70%, >130%
disease or injury affecting the central nervous system
recent use of psychoactive or analgesic medication
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Kanaya
Organization Sendai Medical Center
Division name The department of Anesthesiology
Zip code 983-8520
Address 2-11-12, Myagino, Miyagino-ku, Sendai, Japan
TEL 022-293-1111
Email canal_village0207@yahoo.co.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Kanaya
Organization Sendai Medical Center
Division name The department of Anesthesiology
Zip code 983-8520
Address 2-11-12, Myagino, Miyagino-ku, Sendai, Japan
TEL 022-293-1111
Homepage URL
Email canal_village0207@yahoo.co.jp

Sponsor
Institute Sendai Medical center
Institute
Department

Funding Source
Organization Ministry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethical Review Board of Sendai Medical Center
Address 2-11-12, Myagino, Miyagino-ku, Sendai, Japan
Tel 022-293-1111
Email 113-kanri02@mail.hosp.go.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
2020 Year 09 Month 14 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
2020 Year 09 Month 10 Day
Date of IRB
2020 Year 09 Month 10 Day
Anticipated trial start date
2020 Year 09 Month 14 Day
Last follow-up date
2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 09 Month 14 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047689

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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