UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019773 |
|---|---|
| Receipt number | R000022835 |
| Scientific Title | The effect of general anesthesia on the cerebral perfusion time in patients with carotid artery stenosis : A retrospective study |
| Date of disclosure of the study information | 2015/11/13 |
| Last modified on | 2020/03/18 15:21:50 |
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Basic information
Public title
The effect of general anesthesia on the cerebral perfusion time in patients with carotid artery stenosis : A retrospective study
Acronym
The effect of general anesthesia on the cerebral perfusion time in patients with carotid artery stenosis.
Scientific Title
The effect of general anesthesia on the cerebral perfusion time in patients with carotid artery stenosis : A retrospective study
Scientific Title:Acronym
The effect of general anesthesia on the cerebral perfusion time in patients with carotid artery stenosis.
Region
| Japan |
Condition
Condition
Carotid artery stenosis or occlusion
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the cerebral perfusion time under awake and general anesthesia in patients with carotid artery stenosis .
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time of the arrival of the contrast medium in the major cerebral vessels (ACA, MCA, OA, Veins) under awake vs propofol or awake vs sevoflurane.
Key secondary outcomes
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
Patients undergone AG for diagnosis and CAS under general anesthesia in Tokyo Medical and Dental University from Jan. 1, 2012 to Feb 28, 2017.
Key exclusion criteria
Patients who refused the participation of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Nemoto |
Organization
Tokyo Medical and Dental University,
Graduate School of Medicine and Dental Sciences
Division name
Department of Endovascular Surgery
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5325
nemoto.evs@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Ishibashi |
Organization
Tokyo Medical and Dental University, Graduate School of Medicine and Dental Sciences
Division name
Department of Anesthesiology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5325
Homepage URL
timane@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-6111
mkan-rinsho.adm@tmd.ac.jp
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
| 2015 | Year | 11 | Month | 13 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
We measure the time of the arrival of the contrast medium from the base line in ICA to each cerebral blood vessels with angiographic image under awake and general anesthesia.
Management information
Registered date
| 2015 | Year | 11 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022835
