UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of regional anesthesia on brain waves and cerebral blood flow in patients undergoing general anesthesia
Title of the study (Brief title)	The effects of regional anesthesia on brain waves and cerebral blood flow in patients undergoing general anesthesia
Region	Japan

Condition
Condition	patients undergoing unilateral surgery
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the changes in brain waves and blood flow when regional anesthesia has been performed under general anesthesia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patients who receive unilateral surgery are randomly divided into the group with or without regional anesthesia under general anesthesia, and the differences in the brain waves and cerebral blood flow are investigated.
Key secondary outcomes	blood pressure, heart rate, muscle relaxants monitoring,oxygen saturation(SpO2),arterial oxygen partial pressure(PaO2),arterial carbon dioxide partial pressure(PaCO2),analgesic drugs, the concentration of hemoglobin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	General anesthesia with regional anesthesia duration:during operation dose:0.3% ropivacaine 25ml
Interventions/Control_2	General anesthesia duration:during operation dose:0
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	patients receiving unilateral operation under general anesthesia
Key exclusion criteria	patients receiving cerebral vascular disorder patients receiving coagulation abnormality
Target sample size	100

Research contact person
Name of lead principal investigator	Mina Masuda
Organization	Kagoshima University Hospital
Division name	Department of Anesthesiology
Address	8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
TEL	099-275-5430
Email	mm37@m2kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Keika Mukaihara
Organization	Kagoshima University Hospital
Division name	Department of Anesthesiology
Address	8-35-1 Sakuragaoka, Kagoshima-shi, Kgoshima, Japan
TEL	099-275-5430
Homepage URL
Email	m-keika@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Hospital
Institute
Department

Funding Source
Organization	Kagoshima University
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 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 04 Day
Anticipated trial start date	2016 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 03 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027940