UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of general anesthesia on the cerebral perfusion time in patients undergoing neuroendovascular surgery : A prospective and randomized study.
Title of the study (Brief title)	Comparison of the cerebral perfusion time during general anesthesia for neuroendovascular surgery
Region	Japan

Condition
Condition	Patients undergoing neuroendovascular surgery
Classification by specialty	Anesthesiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the cerebral perfusion time under sevoflurane or propofol anesthesia.
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(anterior cerebral artery, middle cerebral artery, ophthalmic artery, cerebral and cervical veins) under sevoflurane and propofol anesthesia
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	To switch anesthetic from sevoflurane to propofol during procedure
Interventions/Control_2	To switch anesthetic from propofol to sevoflurane during procedure
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	1) Patients with an aneurysm in anterior circulation undergoing elective neuroendovascular surgery (coiling). 2) ASA-PS (ASA: American Society of Anesthesiologists, Physical Status) < III
Key exclusion criteria	1) Patients with a known hypersensitivity to propofol injectable emulsion or any of its component or sevoflurane 2) ASA-PS (ASA: American Society of Anesthesiologists, Physical Status) > IV 3) Patient refusal to the present study 4) Patient considered inappropriate to entry by surgeons or anesthesiologists
Target sample size	20

Research contact person
Name of lead principal investigator	Shigeru Nemoto
Organization	Tokyo Medical and Dental University, Graduate School of Medicine and Dental Sciences
Division name	Department of Endovascular Surgery
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	Tomoko Ishibashi
Organization	Tokyo Medical and Dental University, Graduate School of Medicine and Dental Sciences
Division name	Department of Anesthesiology
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)

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	東京医科歯科大学医学部附属病院（東京都） Tokyo Medical and Dental University, University Hospital of Medicine

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
Anticipated trial start date	2015 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 16 Day
Last modified on	2017 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019210