UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the electroencephalogram under general anesthesia with sevoflurane and desflurane, from the point of bispectral index and 95% spectral edge frequency
Title of the study (Brief title)	Comparison of the electroencephalogram under general anesthesia with desflurane and sevoflurane
Region	Japan

Condition
Condition	Diseases requiring surgery
Classification by specialty	Surgery in general Endocrine surgery Breast surgery Obsterics and gynecology Orthopedics Emergency medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the differences in bispectral index and 95% spectral edge frequency in patients undergoing surgery under general anesthesia with age-adjusted equipotent desflurane and sevoflurane
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Bispectral index under general anesthesia with desflurane or sevoflurane at an end-tidal concentration of 1 MAC (minimum alveolar concentration), approximately 15-20 min following administration of desflurane or sevoflurane
Key secondary outcomes	Ninety-five % spectral edge frequency under general anesthesia with desflurane or sevoflurane at an end-tidal concentration of 1 MAC (minimum alveolar concentration)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	To perform general anesthesia with desflurane at an end-tidal concentration of 1 minimum alveolar concentration (MAC)
Interventions/Control_2	To perform general anesthesia with sevoflurane at an end-tidal concentration of 1 minimum alveolar concentration (MAC)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing surgery under general anesthesia
Key exclusion criteria	Patients with (1) bronchial asthma, (2)arrhythmia, (3) psychiatric diseases or neuromuscular diseases, (4) ischemic heart diseases or decreased cardiac function with left ventricular ejection fraction equal to or less than 40%, (5) hypotension with systolic blood pressure equal to or less than 80 mmHg, (6) serum sodium levels equal to or less than 135 mEq/l; or equal to or more than 148 mEq/l
Target sample size	120

Research contact person
Name of lead principal investigator	Yutaka Oda
Organization	Osaka City General Hospital
Division name	Department of Anesthesiology
Address	2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL	06-6929-1221
Email	odayou@s5.dion.ne.jp

Public contact
Name of contact person	Yutaka Oda
Organization	Osaka City General Hospital
Division name	Department of Anesthesiology
Address	2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL	06-6929-1221
Homepage URL
Email	odayou@s5.dion.ne.jp

Sponsor
Institute	Osaka City General Hospital
Institute
Department

Funding Source
Organization	Department funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	2016 Year 03 Month 14 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 14 Day
Last follow-up date	2016 Year 08 Month 20 Day
Date of closure to data entry	2016 Year 08 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Both BIS and SEF95 were lower in patients receiving age-adjusted 1 MAC desflurane than those receiving 1 MAC sevoflurane.
Other related information

Management information
Registered date	2016 Year 03 Month 11 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024542