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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016130
Receipt No. R000016865
Scientific Title The efficiency of vascular elasticity index as a indicator of pain.
Date of disclosure of the study information 2015/01/06
Last modified on 2018/12/26

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Basic information
Public title The efficiency of vascular elasticity index as a indicator of pain.
Acronym The efficiency of vascular elasticity index as a indicator of pain.
Scientific Title The efficiency of vascular elasticity index as a indicator of pain.
Scientific Title:Acronym 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
1st name
Middle name
Last name Masashi Kawamoto
Organization Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name Department of Anesthesiology and Critical Care
Zip code
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
1st name
Middle name
Last name Ryuji Nakamura
Organization Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name Department of Anesthesiology and Critical Care
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
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

Other
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

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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