UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003997 |
|---|---|
| Receipt number | R000004762 |
| Scientific Title | Mechanisms of anesthetic-induced unconsciousness explored by cortico-cortical evoked potential monitoring in humans |
| Date of disclosure of the study information | 2011/08/05 |
| Last modified on | 2020/03/26 18:36:31 |
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Basic information
Public title
Mechanisms of anesthetic-induced unconsciousness explored by cortico-cortical evoked potential monitoring in humans
Acronym
General anesthesia and cortico-cortical evoked potentials
Scientific Title
Mechanisms of anesthetic-induced unconsciousness explored by cortico-cortical evoked potential monitoring in humans
Scientific Title:Acronym
General anesthesia and cortico-cortical evoked potentials
Region
| Japan |
Condition
Condition
brain tumor, epilepsy
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the cerebral effects of general anesthetics.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cortico-cortical evoked potentials.
Key secondary outcomes
Somatosensory evoked potentials.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
To administer propofol or sevoflurane in differential doses.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing implantation of cortical electrodes or awake craniotomy under general anesthesia.
Key exclusion criteria
Any patients with poorly controlled systemic diseases.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Kurata |
Organization
The Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
075-751-3433
jkurata@plum.plala.or.jp
Public contact
Name of contact person
| 1st name | Jiro |
| Middle name | |
| Last name | Kurata |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Anesthesia
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-3433
Homepage URL
jkurata@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Anesthesia, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia, Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 04 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004762
| Research Plan | |
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| 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 |
