UMIN-CTR Clinical Trial

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

Condition
Condition	Patients undergoing spinal anesthesia
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To discover a new prophecy factor of hypotension after spinal anesthesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association of the light reflex (pupil diameter, MAX/MIN Latency, Average contraction speed/ dilated speed) and hypotension after spinal anesthesia.
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 spinal anesthesia Patients informed consented
Key exclusion criteria	ASA physical status <= 4 Emergency cases History of eye disease, brain infarction, ischemic heart disease, heart failure. WBC>=10000, CRP>=0.3mg/dL, PT-INR>1.2, APTT>41sec, Platelet<100000/uL,
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	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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	2016 Year 08 Month 23 Day
Date of IRB	2016 Year 07 Month 31 Day
Anticipated trial start date	2016 Year 09 Month 01 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	Research perticipants: All patients who underwent spinal anesthesia at Kyushu University Hospital from September 2016. We investigated the relationship between light refection and hypotension after spinal anesthesia. 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/icdr_e/ctr_view.cgi?recptno=R000027335