UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001345 |
|---|---|
| Receipt number | R000001634 |
| Scientific Title | Age-associated differences in the minimum alveolar concentration of volatile anesthetics |
| Date of disclosure of the study information | 2008/09/01 |
| Last modified on | 2009/02/04 20:55:44 |
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Basic information
Public title
Age-associated differences in the minimum alveolar concentration of volatile anesthetics
Acronym
Advance of age and requirement of anesthetics
Scientific Title
Age-associated differences in the minimum alveolar concentration of volatile anesthetics
Scientific Title:Acronym
Advance of age and requirement of anesthetics
Region
| Japan |
Condition
Condition
No specific diseases. Patients undergoing operation under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Minimum alveolar concentration of volatile anesthetics (MAC) decreases with advance of age. Although MAC is frequently used as an indicator of the potency of anesthetics, it is determined based on the potency of inhibiting spinal reflex in response to noxious stimuli, not inhibiting the cerebral cortex activity. We examine whether advance of age decreases the concentration of anesthetics required to inhibit the cerebaral cortex activity based on the electroencephalogram
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of anesthetics for maintaining bispectral index below 50
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Isoflurane is used in patients equal to or less than forty years old
Interventions/Control_2
Isoflurane is used in patients between forty-one to sixty-nine years old
Interventions/Control_3
Isoflurane is used in patients equal to or more than seventy years old
Interventions/Control_4
Sevoflurane is used in patients equal to or less than forty years old
Interventions/Control_5
Sevoflurane is used in patients between forty-one to sixty-nine years old
Interventions/Control_6
Sevoflurane is used in patients equal to or more than seventy years old
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing operation under general anesthesia with tracheal intubation
Key exclusion criteria
Patients with cardiovascular or psychiatric diseases, or with abnormal electroencephalogram
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Oda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Oda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka City University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
http://bja.oxfordjournals.org/papbyrecent.dtl
Publication of results
Published
Result
URL related to results and publications
http://bja.oxfordjournals.org/papbyrecent.dtl
Number of participants that the trial has enrolled
Results
Advance of age significantly decreases the concentration of isoflurane and sevoflurane 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
| 2005 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 30 | Day |
Last modified on
| 2009 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001634
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
