UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006043 |
|---|---|
| Receipt number | R000007140 |
| Scientific Title | The hemodynamic effects of local anethetic injection into the carotid sinus area by urtrasound-guided technique during carotid artery stenting |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2013/08/02 21:46:56 |
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Basic information
Public title
The hemodynamic effects of local anethetic injection into the carotid sinus area by urtrasound-guided technique during carotid artery stenting
Acronym
Local anethetic injection into the carotid sinus during carotid artery stenting
Scientific Title
The hemodynamic effects of local anethetic injection into the carotid sinus area by urtrasound-guided technique during carotid artery stenting
Scientific Title:Acronym
Local anethetic injection into the carotid sinus during carotid artery stenting
Region
| Japan |
Condition
Condition
Patients scheduled carotid artery stenting
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether local anesthetic injection into the carotid sinus area by
ultrasound-guided technique reduces hypotention and bradycardia during CAS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of hemodynamic depression which is considered to be an occurrence of hypotension or bradycardia during CAS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Local anesthetic injection of the carotid sinus area by urtrasound-guided technique
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled carotid artery stenting
2.Carotid artery stenosis is 50% or over
3.Age (20<= <80 year-old)
4.Patients given written informed consent
Key exclusion criteria
1.Ischemic stroke within 48 hours
2.Hemorrhagic stroke within 90 days
3.Congestive heart failure at NYHA III or IV
4.Prior radical neck dissection or neck radiotherapy
5.bleeding tendency
6.Patients who are ineligible in the opinion of the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yoshihito morita |
Organization
Juntendo university hospital
Division name
Anesthesiology and pain Medicine
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo university hospital
Division name
Anesthesiology and pain Medicine
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology and Pain Medicine, Juntendo University
Institute
Department
Personal name
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)
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
| 2011 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | 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
| 2011 | Year | 07 | Month | 26 | Day |
Last modified on
| 2013 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007140
