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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010894
Receipt No. R000012704
Scientific Title Correlation of bispectral index values from two different montage : frontal montage vs madible montage
Date of disclosure of the study information 2013/06/14
Last modified on 2014/04/28

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Basic information
Public title Correlation of bispectral index values from two different montage : frontal montage vs madible montage
Acronym comparison of BIS values from frontal and mandible montage
Scientific Title Correlation of bispectral index values from two different montage : frontal montage vs madible montage
Scientific Title:Acronym comparison of BIS values from frontal and mandible montage
Region
Asia(except Japan)

Condition
Condition elective surgery
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we evaluated the correlation of bispectral index values from frontal and mandible montage
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes similarity of two bispectral index fron frontal and mandible montage
Key secondary outcomes confidence of SQI and EMG

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 frontal montage
Interventions/Control_2 madible montage
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status 1-2 who was scheduled for elective surgery
Key exclusion criteria patients with a history of neurosurgery, disabling central nervous or cerebrovascular disease and receiving CNS active or psychiatric medication.
Target sample size 58

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Il-Ok Lee
Organization Korea University
Division name Anesthesiology and Pain Medicine
Zip code
Address Gurodong-ro 148, Guro-gu, Seoul, Korea
TEL 82-2-2626-3234
Email iloklee@korea.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Il-Ok Lee
Organization Korea University
Division name Anestheology and Pain medicine
Zip code
Address 148 gurodong-ro, guro-u, Seoul
TEL 82-2-2626-3234
Homepage URL
Email iloklee@korea.ac.kr

Sponsor
Institute Korea University
Institute
Department

Funding Source
Organization Korea university
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 06 Month 14 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
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
2013 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 20 Day
Last follow-up date
2013 Year 12 Month 13 Day
Date of closure to data entry
2013 Year 12 Month 13 Day
Date trial data considered complete
2013 Year 12 Month 13 Day
Date analysis concluded
2013 Year 12 Month 27 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 07 Day
Last modified on
2014 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012704

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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