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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009416
Receipt No. 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

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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
Email 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
Email ishiyama@yamaanshi.ac.jp

Sponsor
Institute University of Yamanashi
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011064

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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