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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024263
Receipt No. R000027940
Scientific Title The effects of regional anesthesia on brain waves and cerebral blood flow in patients undergoing general anesthesia
Date of disclosure of the study information 2016/10/04
Last modified on 2018/10/08

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Basic information
Public title The effects of regional anesthesia on brain waves and cerebral blood flow in patients undergoing general anesthesia
Acronym The effects of regional anesthesia on brain waves and cerebral blood flow in patients undergoing general anesthesia
Scientific Title The effects of regional anesthesia on brain waves and cerebral blood flow in patients undergoing general anesthesia
Scientific Title:Acronym 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
1st name
Middle name
Last name Mina Masuda
Organization Kagoshima University Hospital
Division name Department of Anesthesiology
Zip code
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
1st name
Middle name
Last name Keika Mukaihara
Organization Kagoshima University Hospital
Division name Department of Anesthesiology
Zip code
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)

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 10 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 08 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027940

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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