UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of general anesthesia with sevoflurane at age-adjusted concentration on electrocorticography, compared with 2.5% in patients with intractable epilepsy
Title of the study (Brief title)	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	Yutaka Oda
Organization	Osaka City General Hospital
Division name	Anesthesiology
Address	2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL	+81-6-6929-1221
Email	odayou@s5.dion.ne.jp

Public contact
Name of contact person	Yutaka Oda
Organization	Osaka City General Hospital
Division name	Anesthesiology
Address	2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL	+81-6-6929-1221
Homepage URL
Email	odayou@s5.dion.ne.jp

Sponsor
Institute	Osaka City General Hospital
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022648