UMIN-CTR Clinical Trial

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
Last 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
Email	rtanaka@shinshu-u.ac.jp

Public contact
1st 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
Email	rtanaka@shinshu-u.ac.jp

Sponsor
Institute	Shinshu university school of medicine
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020445