UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010640 |
|---|---|
| Receipt number | R000012445 |
| Scientific Title | The impact of hyperventilation on regional cerebral oxygen saturation measured by NIRS under propofol general anesthesia |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2013/05/03 10:25:55 |
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Basic information
Public title
The impact of hyperventilation on regional cerebral oxygen saturation measured by NIRS under propofol general anesthesia
Acronym
The impact of hyperventilation on regional cerebral oxygen saturation under propofol general anesthesia
Scientific Title
The impact of hyperventilation on regional cerebral oxygen saturation measured by NIRS under propofol general anesthesia
Scientific Title:Acronym
The impact of hyperventilation on regional cerebral oxygen saturation under propofol general anesthesia
Region
| Japan |
Condition
Condition
regional cerebral oxygen saturation under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I validate impact of Respirator condition under general anesthesia, particular hyperventilation, on regional cerebral oxygen saturation measured by NIRS . In addition, I compare whether there is a difference in propofol anesthesia and sevoflurane anesthesia that change
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference on regional cerebral oxygen saturation under hyperventilation conditions in propofol anesthesia and sevoflurane anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
sevoflurane
Interventions/Control_2
propofol
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy Men and women over 20 years old
Key exclusion criteria
patients with neurologic disease, cardiac disease, renal disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Matsukawa |
Organization
Faculty of Medicine, University of Yamanashi
Division name
Department of Anesthesiology
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL
0552731111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Faculty of Medicine, University of Yamanashi
Division name
Department of Anesthesiology
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, University of Yamanashi
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 03 | Day |
Last modified on
| 2013 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012445
| Research Plan | |
|---|---|
| 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 |
