UMIN-CTR Clinical Trial

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
Email	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
Email	notinvasive@snubh.org

Sponsor
Institute	Seoul National University Bundang Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042102