UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016551 |
|---|---|
| Receipt number | 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 11:07:56 |
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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
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
timane@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019210
