UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficiency of vascular elasticity index as a indicator of pain.
Title of the study (Brief title)	The efficiency of vascular elasticity index as a indicator of pain.
Region	Japan

Condition
Condition	Elective surgery patient over 20 yrs
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to confirm the usefulness of the vascular elasticity index as a new quantitative pain monitor in anesthetised patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference of the vascular elasticity index between pre-laryngoscopy and post-laryngoscopy between two groups.
Key secondary outcomes	The difference of the vascular elasticity index between two different concentration of analgesics during surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Duration: At laryngoscopy. Frequency: 1 time at laryngoscopy. Remifentanil concentration:2ng/ml or 6ng/ml at laryngoscopy.
Interventions/Control_2	Duration: During surgry. Frequency: 3 times or less during surgery. Remifentanil concentration:2ng/ml to 6ng/ml or 6ng/ml to 2ng/ml during surgery.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who is planned measuring arterial pressure by arterial catheter and endtracheal intubation. Patients who are given informed consent.
Key exclusion criteria	Patients who have atrial fibrillation. Patients who are not suitable for invasive blood pressure monitoring by a radial artery. Patients who have a severe stenosis of artery or a nerve injury at upper limb. Patients who have severe cerebral vascular disease. Patients who withdrew informed consent.
Target sample size	40

Research contact person
Name of lead principal investigator	Masashi Kawamoto
Organization	Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name	Department of Anesthesiology and Critical Care
Address	1-2-3,Kasumi,Minami-ku,Hiroshima
TEL	081-082-256-3234
Email	anekawa@hiroshima-u.ac.jp

Public contact
Name of contact person	Ryuji Nakamura
Organization	Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name	Department of Anesthesiology and Critical Care
Address	1-2-3,Kasumi,Minami-ku,Hiroshima
TEL	081-082-256-3234
Homepage URL
Email	r-nacamura@hiroshima-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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	広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 06 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 06 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016865