UMIN-CTR Clinical Trial

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
Email	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
Email	timane@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022835