UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034363 |
|---|---|
| Receipt number | R000039171 |
| Scientific Title | Analysis of multi-channel EEG during anesthesia |
| Date of disclosure of the study information | 2018/10/02 |
| Last modified on | 2021/04/11 23:26:53 |
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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 | Satoshi |
| Middle name | |
| Last name | Hagihira |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata City, Osaka
TEL
072-804-2683
hagihirs@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hagihira |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata City, Osaka
TEL
072-804-2683
Homepage URL
hagihirs@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
IRB of Kansai Medical University
Address
2-3-1, Shin-machi, Hirakata City, Osaka
Tel
072-804-0101
hagihirs@hirakata.kmu.ac.jp
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039171
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/11/08 | 研究計画書_脳波_final3.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
