UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021895 |
|---|---|
| Receipt number | R000025210 |
| Scientific Title | Which is more reliable, BIS value or AEP value in the presence of artifacts during orthognathic surgery? |
| Date of disclosure of the study information | 2016/04/13 |
| Last modified on | 2017/04/19 12:49:55 |
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Basic information
Public title
Which is more reliable, BIS value or AEP value in the presence of artifacts during orthognathic surgery?
Acronym
Which is more reliable, BIS value or AEP value in the presence of artifacts during orthognathic surgery?
Scientific Title
Which is more reliable, BIS value or AEP value in the presence of artifacts during orthognathic surgery?
Scientific Title:Acronym
Which is more reliable, BIS value or AEP value in the presence of artifacts during orthognathic surgery?
Region
| Japan |
Condition
Condition
Adult patients who are scheduled for orthognathic surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We attempt to assess which is more reliable for sedation monitoring, BIS value or AEP value in the presence of artifacts during orthognathic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the variability regions of BIS value and AEP value during the operation
Key secondary outcomes
Comparison of BIS value or AEP value with autonomic activity evaluated by heart rate variability
Comparison of BIS value and AEP value with serum cortisol level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects undergo general anesthesia applying both BIS electrodes and AEP electrodes.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients who are scheduled for orthognathic surgery
Key exclusion criteria
ASA PS 3-4
Patients who have a disease of cardiovascular, autonomic nervous, or endocrine system
Patients who have a disease associated with auditory nerve, or auditory neural pathway
Patients with skin abnormality at ear or forehead
Patients who presented positive reaction of Allen test
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chizuko Yokoe |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology
Zip code
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa 238-0004 Japan
TEL
046-822-8842
yokoe@kdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chizuko Yokoe |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology
Zip code
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa 238-0004 Japan
TEL
046-822-8842
Homepage URL
yokoe@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
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
神奈川歯科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 13 | 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
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 13 | Day |
Last modified on
| 2017 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025210
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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