UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019603 |
|---|---|
| Receipt number | R000022648 |
| Scientific Title | Effect of general anesthesia with sevoflurane at age-adjusted concentration on electrocorticography, compared with 2.5% in patients with intractable epilepsy |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2016/12/30 20:19:34 |
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Basic information
Public title
Effect of general anesthesia with sevoflurane at age-adjusted concentration on electrocorticography, compared with 2.5% in patients with intractable epilepsy
Acronym
Effect of sevoflurane concentration on the electrocorticography
Scientific Title
Effect of general anesthesia with sevoflurane at age-adjusted concentration on electrocorticography, compared with 2.5% in patients with intractable epilepsy
Scientific Title:Acronym
Effect of sevoflurane concentration on the electrocorticography
Region
| Japan |
Condition
Condition
intractable epilepsy
Classification by specialty
| Neurology | Pediatrics | Anesthesiology |
| Neurosurgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal concentration of an inhalational anesthetic for surgical treatment of intractable epilepsy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of spikes during anesthesia
Key secondary outcomes
The area where spikes are detected during anesthesia
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Electrocorticogram is recorded with the end-tidal concentration of sevoflurane at 1.5 x age-adjusted minimum alveolar concentration, followed by recording with the end-tidal concentration of sevoflurane at 2.5%, irrespective of the patients' age.
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
| 3 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgical treatment of intractable epilepsy with American Society of Anesthesiologists physical status I-III
Key exclusion criteria
Patients with ischemic heart disease or decreased cardiac function with left ventricular ejection fraction equal to or less than 40%
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Oda |
Organization
Osaka City General Hospital
Division name
Anesthesiology
Zip code
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
+81-6-6929-1221
odayou@s5.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Oda |
Organization
Osaka City General Hospital
Division name
Anesthesiology
Zip code
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
+81-6-6929-1221
Homepage URL
odayou@s5.dion.ne.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka City General Hospital
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
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 | 11 | 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
The incidence and the number of leads with epileptic discharge in pediatric patients receiving 1.5 MAC sevoflurane were signifcantly larger than those receiving 2.5% sevoflurane.
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
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 02 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2016 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022648
