UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position
Title of the study (Brief title)	Beach chair position and changes in cerebral oxygen saturation
Region	Japan

Condition
Condition	Patients schedules to have arthroscopic shoulder surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate a brain oxygen saturation change in the arthroscope shoulder surgery with the beach chair position using NIRO-200NX which can measure it with both spatial resolved and Lambert-Beer methods.
Basic objectives2	Others
Basic objectives -Others	Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	brain oxygen saturation changes in the arthroscope shoulder surgery with the beach chair position
Key secondary outcomes	postoperative dementia and complications

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 and Female
Key inclusion criteria	The patients with written informed consent
Key exclusion criteria	1 Patients with cerebrovascular disease 2 Patients orthostatic hypotension 3 ASA-PS 3,4,5
Target sample size	21

Research contact person
Name of lead principal investigator	Yuji Morimoto
Organization	Hokkaido University Hospital
Division name	Anesthesiology
Address	N14 W5, Kita-ku, Sapporo
TEL	011-716-1161
Email	morim2@med.hokudai.ac.jp

Public contact
Name of contact person	Yuji Morimoto
Organization	Hokkaido University Hospital
Division name	Anesthesiology
Address	N14 W5, Kita-ku, Sapporo
TEL	011-716-1161
Homepage URL
Email	morim2@med.hokudai.ac.jp

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	2017 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 15 Day
Anticipated trial start date	2015 Year 11 Month 10 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective observational study Observational items: Background, laboratory data, vital signs during operation cerebral oxygenation, postoperative dementia and complications

Management information
Registered date	2017 Year 04 Month 30 Day
Last modified on	2018 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031079