UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021895
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yokoe@kdu.ac.jp

Sponsor
Institute Kanagawa Dental University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.