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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023670
Receipt No. R000027265
Scientific Title Changes in cerebral blood volume and oxygenation during steep Trendelenburg position in robotic prostatectomy by using new style near infrared spectroscopy
Date of disclosure of the study information 2016/08/29
Last modified on 2018/02/18

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Basic information
Public title Changes in cerebral blood volume and oxygenation during steep Trendelenburg position in robotic prostatectomy by using new style near infrared spectroscopy
Acronym Changes in cerebral blood volume and oxygenation during robotic prostatectomy
Scientific Title Changes in cerebral blood volume and oxygenation during steep Trendelenburg position in robotic prostatectomy by using new style near infrared spectroscopy
Scientific Title:Acronym Changes in cerebral blood volume and oxygenation during robotic prostatectomy
Region
Japan

Condition
Condition Patients scheduled to have robotic prostatectomy
Classification by specialty
Urology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes in cerebral blood volume and oxygenation during steep Trendelenburg position in robotic prostatectomy, cerebral hemoglobin concentration and oxygenation was continuously measured by using new style near infrared spectroscopy, tNIRS-1.
Basic objectives2 Others
Basic objectives -Others Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cerebral total hemoglobin concentration as an index of cerebral blood volume
Key secondary outcomes Cerebral oxygen saturation

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Key inclusion criteria Patients who have robotic prostatectomy in the urology department of Hokkaido University Hospital
Key exclusion criteria 1 Patient with the complications of the cerebrovascular disease
2 Patient with the orthostatic hypotension
3 ASA-PS3,4,5
4 the operation is changed to laparotomy
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Tanaka
Organization Hokkaido University Hospital
Division name Anesthesiology
Zip code
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Email dorami1105@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Tanaka
Organization Hokkaido University Hospital
Division name Anesthesiology
Zip code
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email dorami1105@hotmail.com

Sponsor
Institute Hokkaido University Hospital
Anesthesiology
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 29 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 Completed
Date of protocol fixation
2016 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 29 Day
Last follow-up date
2017 Year 09 Month 10 Day
Date of closure to data entry
2017 Year 10 Month 10 Day
Date trial data considered complete
2017 Year 10 Month 10 Day
Date analysis concluded
2017 Year 11 Month 30 Day

Other
Other related information Prospective observational study

Study period: until 2017.9.10

Patients who have robotic prostatectomy in the urology department of Hokkaido University Hospital and meet the criteria

Observational items: Background, laboratory data, vital signs during operation, cerebral hemoglobin concentration and oxygenation

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2018 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027265

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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