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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014592
Receipt No. R000016977
Scientific Title Age-dependent change of the minimum alveolar concentrations of desflurane for maintaining bispectral index below 50
Date of disclosure of the study information 2014/07/20
Last modified on 2015/07/24

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Basic information
Public title Age-dependent change of the minimum alveolar concentrations of desflurane for maintaining bispectral index below 50
Acronym Advance of age and requirement of desflurane
Scientific Title Age-dependent change of the minimum alveolar concentrations of desflurane for maintaining bispectral index below 50
Scientific Title:Acronym Advance of age and requirement of desflurane
Region
Japan

Condition
Condition Deseases requiring surgical treatment under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Desflurane is a new inhalational anesthetic with rapid onset and withdrawal, which is useful for general anesthesia in elderly patients. However, its effect on depth of anesthesia in different age groups has not been elucidated. Bispectral index is useful for measuring depth of general anesthesia. We compare the minimum alveolar concentration of desflurane for maintaining bispectral index below 50 in 3 different age groups.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences of the alveolar concentration of desflurane for maintaining bispectral index below 50 (MACBIS 50) among different age groups
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Measuring bispectral index after administrating desflurane for maintaining the end-tidal concentration at a fixed level in patients between 20 and 30 years old undergoing general anesthesia.
Interventions/Control_2 Measuring bispectral index after administrating desflurane for maintaining the end-tidal concentration at a fixed level in patients between 31 and 65 years undergoing general anesthesia.
Interventions/Control_3 Measuring bispectral index after administrating desflurane for maintaining the end-tidal concentration at a fixed level in patients between 66 and 84 years undergoing general anesthesia.
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing general anesthesia under tracheal intubation with American Society of Anesthesiologists physical status I or II
Key exclusion criteria Patients with bronchial asthma, arrhythmia, psychiatric disorder, ischemic heart diseases, low cardiac output with ejection fraction equal to or less than 40%, systolic blood pressure below 80 mmHg or abnormal serum electrolytes
Target sample size 25

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yutaka Oda
Organization Osaka City General Hospital and Children's Hospital
Division name Department of Anesthesiology
Zip code
Address 2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL 06-6929-1221
Email odayou@s5.dion.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yutaka Oda
Organization Osaka City General Hospital and Children's Hospital
Division name Department of Anesthesiology
Zip code
Address 2-13-22 Miyakojima-Hondori, Miyakojima-ku, Osaka
TEL 06-6929-1221
Homepage URL
Email odayou@s5.dion.ne.jp

Sponsor
Institute Department of Anesthesiology, Osaka City General Hospital and Children's Hospital
Institute
Department

Funding Source
Organization none
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
Email

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 大阪市立総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There were significant differences among young, middle-aged and elderly patients in the concentration of desflurane for maintaining bispectral index below 50.
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 Completed
Date of protocol fixation
2014 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 22 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2015 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016977

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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