UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014592 |
|---|---|
| Receipt number | 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 21:54:55 |
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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
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
odayou@s5.dion.ne.jp
Public contact
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
odayou@s5.dion.ne.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City General Hospital and Children's Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016977
