UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017164 |
|---|---|
| Receipt number | R000019910 |
| Scientific Title | The changes in electroencephalogram and cerebral blood flow during anesthesia in patients undergoing surgery |
| Date of disclosure of the study information | 2015/04/17 |
| Last modified on | 2015/04/17 19:17:11 |
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Basic information
Public title
The changes in electroencephalogram and cerebral blood flow during anesthesia in patients undergoing surgery
Acronym
The changes in electroencephalogram and cerebral blood flow during anesthesia
Scientific Title
The changes in electroencephalogram and cerebral blood flow during anesthesia in patients undergoing surgery
Scientific Title:Acronym
The changes in electroencephalogram and cerebral blood flow during anesthesia
Region
| Japan |
Condition
Condition
surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is finding the appropriate indicator for anesthetic management by monitoring the changes in EEG and rSO2 induced by surgical stress.
Basic objectives2
Others
Basic objectives -Others
The appropriate anesthetic management includes analgesia and anesthetic depth.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The specific changes by pain and surgical stress may affect on the monitoring index such as bilateral BIS and NIRS.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective surgery
Key exclusion criteria
Patients undergoing emergency surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maiko Hasegawa |
Organization
Kagoshima University Hospital
Division name
Department of Anesthesiology
Zip code
Address
8-35-1 Sakuragaoka Kagoshima-city
TEL
099-275-5430
hase-mai@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Hasegawa |
Organization
Kagoshima University Hospital
Division name
Department of Anesthesiology
Zip code
Address
8-35-1 Sakuragaoka Kagoshima-city
TEL
099-275-5430
Homepage URL
hase-mai@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Kagoshima University School of Medicine
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
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
| 2015 | Year | 04 | Month | 17 | 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
| 2014 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
prospective study
Management information
Registered date
| 2015 | Year | 04 | Month | 17 | Day |
Last modified on
| 2015 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019910
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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