UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036951 |
|---|---|
| Receipt number | R000042102 |
| Scientific Title | A comparison of the hemodynamic stability between Inhaled general anesthesia and Total Intraveous Anesthesia (TIVA) undergoing coil embolization |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2020/07/03 08:56:49 |
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Basic information
Public title
A comparison of the hemodynamic stability between Inhaled general anesthesia and Total Intraveous Anesthesia (TIVA) undergoing coil embolization
Acronym
hemodynamic stability
Scientific Title
A comparison of the hemodynamic stability between Inhaled general anesthesia and Total Intraveous Anesthesia (TIVA) undergoing coil embolization
Scientific Title:Acronym
hemodynamic stability
Region
| Asia(except Japan) |
Condition
Condition
retrospective
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Need no amendment
Basic objectives2
Others
Basic objectives -Others
hemodynammic stability
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
vital sign (BP,HR)
Key secondary outcomes
amount of used inotropics
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing coil embolization by Inhaled general anesthesia or Total Intraveous Anesthesia (TIVA) at the Seoul National University Bundang Hospital
Key exclusion criteria
Patients who underwent simultaneous neurosurgical procedures with intracranial aneurysm embolization
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Sung Ju |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam Gyeonggi-do
TEL
82317873641
struka@snubh.org
Public contact
Name of contact person
| 1st name | Bo Young |
| Middle name | |
| Last name | Kim |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam Gyeonggi-do
TEL
82317873641
Homepage URL
notinvasive@snubh.org
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
Seoul National University Bundang Hospital
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
Institutional Review Board of Seoul National University Bundang Hospital
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam Gyeonggi-do
Tel
82317873941
ctc01@snubh.org
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
| 2019 | Year | 06 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
after fixing the patient enrollment, electrical medical record will be reviewed. Data of HR, BP and inotropics used will be collected and analyzed.
Management information
Registered date
| 2019 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042102
