UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of efficacy of laser blood flow meter during spinal anesthesia
Title of the study (Brief title)	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	TAKAYUKI MURAKAMI
Organization	Fukuchiyama City Hospital
Division name	Anesthesiology
Address	231,Atsunakacho,Fukuchiyama city,Kyoto
TEL	0773222101
Email	mura0528@koto.kpu-m.ac.jp

Public contact
Name of contact person	TAKAYUKI MURAKAMI
Organization	Fukuchiyama City Hospital
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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