UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Which is more reliable, BIS value or AEP value in the presence of artifacts during orthognathic surgery?
Title of the study (Brief title)	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	Chizuko Yokoe
Organization	Kanagawa Dental University
Division name	Department of Anesthesiology
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	Chizuko Yokoe
Organization	Kanagawa Dental University
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 11 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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