UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009416 |
|---|---|
| Receipt number | R000011064 |
| Scientific Title | Changes of arterial oxygen saturation and cerebral oxygen saturation after the use of patent blue in a patient receiving breast cancer operation |
| Date of disclosure of the study information | 2012/11/28 |
| Last modified on | 2015/06/01 13:15:59 |
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Basic information
Public title
Changes of arterial oxygen saturation and cerebral oxygen saturation after the use of patent blue in a patient receiving breast cancer operation
Acronym
Patent blue and cerebral oxygen saturation
Scientific Title
Changes of arterial oxygen saturation and cerebral oxygen saturation after the use of patent blue in a patient receiving breast cancer operation
Scientific Title:Acronym
Patent blue and cerebral oxygen saturation
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in SpO2 and cerebral oxygen saturation, which is measured by INVOS, after patent blue injection under sevoflurane or propofol anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in SpO2 and cerebral oxygen saturation.
Key secondary outcomes
Differences of changes in SpO2 and cerebral oxygen saturation between sevoflurane and propofol anesthesia.
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
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
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
Patients who undergo breast cancer operation to which patent blue is injected.
Key exclusion criteria
Patients who have diseased in central nervous system such as cerebral infarction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadahiko Ishiyama |
Organization
University of Yamanashi Hospital
Division name
Surgical Center
Zip code
Address
1110 Shimokato, Chuo, Yamanashi
TEL
055-273-1111
ishiyama@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahiko Ishiyama |
Organization
University of Yamanashi Hospital
Division name
Surgical Center
Zip code
Address
1110 Shimokato, Chuo, Yamanashi
TEL
055-273-1111
Homepage URL
ishiyama@yamaanshi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi
Organization
Division
Category of Funding Organization
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
山梨大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 28 | 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
Patent Blue did not decrease
arterial blood oxyhaemoglobin saturation, but it did reduce mean (SD) digital and cerebral oxyhaemoglobin saturations
by 1.1 (1.1) % and 6.8 (7.0) %, p < 0.0001 for both. The falsely reduced oximeter readings persisted for at least
2 h. The mean (SD) intra-operative digital pulse oxyhaemoglobin readings were lower with sevoflurane than propofol,
97.8 (1.2) % and 98.8 (1.0) %, respectively, p < 0.0001.
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
| 2012 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 29 | 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
| 2012 | Year | 11 | Month | 28 | Day |
Last modified on
| 2015 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011064
| 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 |
