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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012145
Receipt No. R000014198
Scientific Title A comparison of bispectral index and entropy during sevoflurane anesthesia induction, in normal children and children with cerebral palsy
Date of disclosure of the study information 2013/10/28
Last modified on 2014/04/28

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Basic information
Public title A comparison of bispectral index and entropy during sevoflurane anesthesia induction, in normal children and children with cerebral palsy
Acronym Bispectral index and entropy during sevoflurane anesthesia induction in cerebral palsy
Scientific Title A comparison of bispectral index and entropy during sevoflurane anesthesia induction, in normal children and children with cerebral palsy
Scientific Title:Acronym Bispectral index and entropy during sevoflurane anesthesia induction in cerebral palsy
Region
Asia(except Japan)

Condition
Condition elective surgery
Classification by specialty
Neurology Orthopedics Anesthesiology
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare bispectral index and entropy change
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to predict unresponsiveness by BIS or entropy
Key secondary outcomes

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
5 years-old <
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria CP
Key exclusion criteria MR
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Lee Il-Ok
Organization Korea University
Division name anesthesiology and pain medicine
Zip code
Address gurodong-ro 148, guro-gu, Seoul, Republic of Korea
TEL 82-2-2626-3234
Email iloklee@korea.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Lee Il-Ok
Organization Korea University
Division name anesthesiology and pain medicine
Zip code
Address Korea university guro hospital
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 10 Month 28 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 Enrolling by invitation
Date of protocol fixation
2013 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 28 Day
Last follow-up date
2014 Year 03 Month 28 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 04 Month 04 Day
Date analysis concluded
2014 Year 04 Month 04 Day

Other
Other related information The BIS and entropy
Sedation status (OAA/S)

Management information
Registered date
2013 Year 10 Month 28 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=R000014198

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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