UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021448 |
|---|---|
| Receipt number | R000024542 |
| Scientific Title | Comparison of the electroencephalogram under general anesthesia with sevoflurane and desflurane, from the point of bispectral index and 95% spectral edge frequency |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2017/09/11 20:10:55 |
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Basic information
Public title
Comparison of the electroencephalogram under general anesthesia with sevoflurane and desflurane, from the point of bispectral index and 95% spectral edge frequency
Acronym
Comparison of the electroencephalogram under general anesthesia with desflurane and sevoflurane
Scientific Title
Comparison of the electroencephalogram under general anesthesia with sevoflurane and desflurane, from the point of bispectral index and 95% spectral edge frequency
Scientific Title:Acronym
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 |
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Yutaka Oda |
Organization
Osaka City General Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
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
Department of Anesthesiology
Zip code
Address
2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
Homepage URL
odayou@s5.dion.ne.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department funding
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
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
| 2016 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Both BIS and SEF95 were lower in patients receiving age-adjusted 1 MAC desflurane than those receiving 1 MAC 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024542
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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