UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010646 |
|---|---|
| Receipt number | R000012438 |
| Scientific Title | Clinical research on the influence of propofol on electroencephalography recorded by intracranial electrodes |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2023/12/08 18:31:21 |
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Basic information
Public title
Clinical research on the influence of propofol on electroencephalography recorded by intracranial electrodes
Acronym
Clinical research on the influence of propofol on electroencephalography recorded by intracranial electrodes
Scientific Title
Clinical research on the influence of propofol on electroencephalography recorded by intracranial electrodes
Scientific Title:Acronym
Clinical research on the influence of propofol on electroencephalography recorded by intracranial electrodes
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of propofol on intracranial electroencephalography (EEG).
To establish the optimal method for propofol anesthesia during intraoperative EEG monitoring.
Basic objectives2
Others
Basic objectives -Others
Influence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalographic changes
Key secondary outcomes
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Cessation of analgesics and traquillisers
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with intractable epilepsy who is seleceted for awake craniotomy
Key exclusion criteria
Patients who disagree with this research
Pregnant women
Children under 15 years old
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
6068507
Address
54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
TEL
075-751-3653
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Inada |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
6068508
Address
54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
TEL
075-751-3695
Homepage URL
inada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Department of Neurosurgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital Ethics Comittee
Address
54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
Tel
075-751-3695
ethcom@kuhp.kyoto-u.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
| 2013 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
https://kyoto.bvits.com/rinri/Apply/show.aspx?TYPE=8&ID=9732
Publication of results
Unpublished
Result
URL related to results and publications
https://kyoto.bvits.com/rinri/Apply/show.aspx?TYPE=8&ID=9732
Number of participants that the trial has enrolled
10
Results
We analyzed the influence of HFOs under propofol anesthesia, that could be distinguish the epileptogenic zone from non-epileptogenic zone.
Results date posted
| 2022 | Year | 12 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients of refractory epilepsy
Participant flow
Record the electro-corticogram under general anesthesia
Adverse events
None
Outcome measures
Distinguish the epileptogenic zone frome non-epileptogenic zone
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 05 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012438
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
