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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023729
Receipt No. R000027333
Scientific Title Study of the relationship between preoperative light reflection and hypotension during induction of anesthesia
Date of disclosure of the study information 2016/08/23
Last modified on 2019/08/27

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Basic information
Public title Study of the relationship between preoperative light reflection and hypotension during induction of anesthesia
Acronym Study of light reflection and hypotension
Scientific Title Study of the relationship between preoperative light reflection and hypotension during induction of anesthesia
Scientific Title:Acronym Study of light reflection and hypotension
Region
Japan

Condition
Condition Patients undergoing general anesthesia
Classification by specialty
Anesthesiology Operative medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To discover a new prophecy factor of hypotension during induction of anesthesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The association of the light reflex (pupil diameter, MAX/MIN Latency, Average contraction speed/ dilated speed) and hypotension during anesthesia induction
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
21 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing general anesthesia
Patients informed consented
Key exclusion criteria Patients undergoing epidural anesthesia
ASA physical status <= 4
Emergency cases
History of eye disease, brain infarction, ischemic heart disease, heart failure.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Sumio
Middle name
Last name Hoka
Organization Kyushu University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 8128582
Address Maidashi3-1-1, Higashi-ku, Fukuoka
TEL +81926425714
Email shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Ryohei
Middle name
Last name Miyazaki
Organization Kyushu University Hospital
Division name Operating rooms
Zip code 8128582
Address Maidashi3-1-1, Higashi-ku, Fukuoka
TEL +81926425714
Homepage URL
Email miyaryou@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University IRB
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel +816425714
Email ijkseimei@jimu.kyushu-u.ac.jp

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
2016 Year 08 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 79
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 08 Month 17 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
2016 Year 07 Month 30 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2019 Year 08 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research perticipants: All patients who underwent general anesthesia at Kyushu University Hospital from September 2016.
We measured pupil diameter, MAX or MIN latency, contraction or dilation speed using pupil recorder (NPi 100).

Management information
Registered date
2016 Year 08 Month 23 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027333

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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