UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024263 |
|---|---|
| Receipt number | 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 10:48:25 |
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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
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
m-keika@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027940
