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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032213
Receipt No. R000036363
Scientific Title The study of efficacy of laser blood flow meter during spinal anesthesia
Date of disclosure of the study information 2018/04/12
Last modified on 2018/04/12

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Basic information
Public title The study of efficacy of laser blood flow meter during spinal anesthesia
Acronym The study of efficacy of laser blood flow meter during spinal anesthesia
Scientific Title The study of efficacy of laser blood flow meter during spinal anesthesia
Scientific Title:Acronym The study of efficacy of laser blood flow meter during spinal anesthesia
Region
Japan

Condition
Condition The patients who receive spinal anesthesia
(ASA1-2)
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigae the efficacy of laser blood flow meter for determination of anesthetic level during spinal anesthesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between anesthetic levels and blood flow changes of laser blood flow meter 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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status 1 or 2,undergoing surgery with spinal anesthesia
Key exclusion criteria The patients who meet the following criteria

1)More than ASA phisical status 3
2)dysesthesia
3)motor paralysis
4)dysautonomia
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKAYUKI MURAKAMI
Organization Fukuchiyama City Hospital
Division name Anesthesiology
Zip code
Address 231,Atsunakacho,Fukuchiyama city,Kyoto
TEL 0773222101
Email mura0528@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TAKAYUKI MURAKAMI
Organization Fukuchiyama City Hospital
Division name Anesthesiology
Zip code
Address 231,Atsunakacho,Fukuchiyama city,Kyoto
TEL 0773222101
Homepage URL
Email mura0528@koto.kpu-m.ac.jp

Sponsor
Institute Fukuchiyama City Hospital
Institute
Department

Funding Source
Organization Fukuchiyama City Hospital
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 市立福知山市民病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 12 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
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The 50 patients who receive the spinal anesthesia (ASA1-2) are enrolled.

After laser blood flow meters are placed on around the level of nipple(Th4), navel(Th10), lateral femur(L2) on both sides,Flow volume,pulse amplitude and pulse rate and anesthetic levels are recorded.
We checked these parameters before and after intrathecal administration by every few minutes.

Management information
Registered date
2018 Year 04 Month 12 Day
Last modified on
2018 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036363

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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