UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of multi-channnel EEG during anesthesia
Title of the study (Brief title)	Basic study for monitoring consciousness
Region	Japan

Condition
Condition	anesthetized patients
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Currently, EEG monitor is widely used to assess the hypnotic level. These monitors used 1-2 channels of EEG obtained from frontal leads, and often interfered by EMG or other artifacts. The aim of this study is to obtain multi-channels of EEG, remove artifacts by ICA, and then observe the changes of reconstructed EEG signal during the recovery from anesthesia.
Basic objectives2	Others
Basic objectives -Others	Based on the results, we will try to make a monitor of consciousness especially in lightly sedated level.
Trial characteristics_1	Others
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	We will observe the changes re-constructed EEGs during recovery from anesthesia, and compare several features of EEG just before and just after recovery from anesthesia.
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who scheduled elective surgery in a supine position, and obtained written informed consent after careful explanation about the study protocols.
Key exclusion criteria	We exclude the patients who reported neurologic or psychiatric disorders, or medication with drugs known to influence anesthetic or analgesic requirements.
Target sample size	60

Research contact person
Name of lead principal investigator	Satoshi Hagihira
Organization	Osaka Prefectural Osaka General Medical Center
Division name	Surgical Center
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka City
TEL	06-6692-1201
Email	hagihira@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	Satoshi Hagihira
Organization	Osaka Prefectural Osaka General Medical Center
Division name	Surgical Center
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka City
TEL	06-6692-1201
Homepage URL
Email	hagihira@anes.med.osaka-u.ac.jp

Sponsor
Institute	Osaka Prefectural Osaka General Medical Center
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2016 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 11 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	This study was stopped because the main researcher moved to other institute. After approval of the IRB at the new institute, this study will be restarted with new UMIN-ID.
Other related information	This is an observational study.

Management information
Registered date	2016 Year 10 Month 31 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028328