UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in cerebral blood volume and oxygenation during steep Trendelenburg position in robotic prostatectomy by using new style near infrared spectroscopy
Title of the study (Brief title)	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	Nobuhiro Tanaka
Organization	Hokkaido University Hospital
Division name	Anesthesiology
Address	N14 W5, Kita-ku, Sapporo
TEL	011-716-1161
Email	dorami1105@hotmail.com

Public contact
Name of contact person	Nobuhiro Tanaka
Organization	Hokkaido University Hospital
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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