UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023670
Receipt number 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 16:05:11

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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 or person

Institute

Hokkaido University Hospital
Anesthesiology

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


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

Value
https://center6.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