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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016551
Receipt No. R000019210
Scientific Title The effect of general anesthesia on the cerebral perfusion time in patients undergoing neuroendovascular surgery : A prospective and randomized study.
Date of disclosure of the study information 2015/02/20
Last modified on 2017/08/18

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Basic information
Public title The effect of general anesthesia on the cerebral perfusion time in patients undergoing neuroendovascular surgery : A prospective and randomized study.
Acronym Comparison of the cerebral perfusion time during general anesthesia for neuroendovascular surgery
Scientific Title The effect of general anesthesia on the cerebral perfusion time in patients undergoing neuroendovascular surgery : A prospective and randomized study.
Scientific Title:Acronym 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
1st name
Middle name
Last name Shigeru Nemoto
Organization Tokyo Medical and Dental University,
Graduate School of Medicine and Dental Sciences
Division name Department of Endovascular Surgery
Zip code
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
Middle name
Last name Tomoko Ishibashi
Organization Tokyo Medical and Dental University, Graduate School of Medicine and Dental Sciences
Division name Department of Anesthesiology
Zip code
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
Address
Tel
Email

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

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 02 Month 16 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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