UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012145 |
|---|---|
| Receipt number | 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 | 2022/11/21 14:23:14 |
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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
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
iloklee@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 28 | Day |
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
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014198
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
