UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023730 |
|---|---|
| Receipt number | R000027335 |
| Scientific Title | Study of the relationship between preoperative light reflection and hypotension after spinal anesthesia |
| Date of disclosure of the study information | 2016/08/23 |
| Last modified on | 2019/08/27 12:16:22 |
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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
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
miyaryou@kuaccm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027335
