UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017646 |
|---|---|
| Receipt number | R000020445 |
| Scientific Title | The effects of general anesthesia on visual pathway function in human |
| Date of disclosure of the study information | 2015/05/30 |
| Last modified on | 2019/03/25 16:15:00 |
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Basic information
Public title
The effects of general anesthesia on visual pathway function in human
Acronym
The effects of general anesthesia on visual pathway function
Scientific Title
The effects of general anesthesia on visual pathway function in human
Scientific Title:Acronym
The effects of general anesthesia on visual pathway function
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to determine actions of propofol and sevoflurane on electroretinogram (ERG) and visual evoked potential (VEP).
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electroretinogram
Key secondary outcomes
visual evoked potential
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
ERG and VEPs are measured at three different end-tidal concentrations of sevoflurane (0.5-1.5 minimum alveolar concentration).
Interventions/Control_2
ERG and VEPs are measured at three different effect-site concentrations of propofol (1.0-3.0 microgram/ml).
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients (ASA I-II) scheduled for non-neurological elective surgeries are enrolled in this study.
Key exclusion criteria
Patients with decreased visual acuity are excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Ryusuke |
Organization
Shinshu university school of medicine
Division name
Department of anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto Nagano Japan
TEL
0263-37-2670
rtanaka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanaka Ryusuke |
Organization
Shinshu university school of medicine
Division name
Department of anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto Nagano Japan
TEL
0263-37-2670
Homepage URL
rtanaka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 30 | 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 | 03 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020445
