UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016130 |
|---|---|
| Receipt number | 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 17:15:16 |
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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
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
r-nacamura@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016865
| Research Plan | |
|---|---|
| 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 |
