UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037628 |
|---|---|
| Receipt number | R000042831 |
| Scientific Title | Usefulness of second derivative of photoplethysmography for estimating blood pressure decrease during spinal anesthesia |
| Date of disclosure of the study information | 2019/08/09 |
| Last modified on | 2019/08/07 10:41:29 |
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Basic information
Public title
Usefulness of second derivative of photoplethysmography for estimating blood pressure decrease during spinal anesthesia
Acronym
Usefulness of second derivative of photoplethysmography for estimating blood pressure decrease during spinal anesthesia
Scientific Title
Usefulness of second derivative of photoplethysmography for estimating blood pressure decrease during spinal anesthesia
Scientific Title:Acronym
Usefulness of second derivative of photoplethysmography for estimating blood pressure decrease during spinal anesthesia
Region
| Japan |
Condition
Condition
Patients undergoing transurethral resection of the bladder tumor under spinal anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether second derivative of photoplethysmography is potentially correlated with hypotension induced by spinal anesthesia for transurethral resection of the bladder tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity and specificity of second derivative of photoplethysmography for estimating blood pressure decrease during 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who had transurethral resection of the bladder tumor under spinal anesthesia
2. Patients who had spinal anesthesia with hyperbaric bupivacaine
Key exclusion criteria
Cases without key inclusion criteria
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | Hardy |
| Last name | Yamada |
Organization
Gunma University Hospital
Division name
Oncology Center
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi-shi Gunma 371-8511, Japan
TEL
027-220-7927
mkhardyyamada@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | Hardy |
| Last name | Yamada |
Organization
Gunma University Hospital
Division name
Oncology Center
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi-shi Gunma 371-8511, Japan
TEL
027-220-7927
Homepage URL
mkhardyyamada@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number JP 19K09319
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Review Committee for People
Address
3-39-15 Showa-machi Maebashi-shi Gunma 371-8511, Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2019 | Year | 08 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this prospective observation study is to investigate the usefulness of second derivative of photoplethysmography for estimating blood pressure decrease during spinal anesthesia.
Management information
Registered date
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042831
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
