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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034363
Receipt No. R000039171
Scientific Title Analysis of multi-channel EEG during anesthesia
Date of disclosure of the study information 2018/10/02
Last modified on 2018/10/02

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Basic information
Public title Analysis of multi-channel EEG during anesthesia
Acronym Basic study for monitoring consciousness (2)
Scientific Title Analysis of multi-channel EEG during anesthesia
Scientific Title:Acronym Basic study for monitoring consciousness (2)
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
1st name
Middle name
Last name Satoshi Hagihira
Organization Kansai Medical University
Division name Department of Anesthesiology
Zip code
Address 2-5-1 Shinmachi, Hirakata City, Osaka
TEL 072-804-2683
Email hagihirs@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hagihira
Organization Kansai Medical University
Division name Department of Anesthesiology
Zip code
Address 2-5-1 Shinmachi, Hirakata City, Osaka
TEL 072-804-2683
Homepage URL
Email hagihirs@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
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)

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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 02 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This protocol is renewal of UMIN000024662 at the new institute.

Management information
Registered date
2018 Year 10 Month 02 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=R000039171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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