UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036047 |
|---|---|
| Receipt number | R000041057 |
| Scientific Title | effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2021/01/25 16:35:24 |
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Basic information
Public title
effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Acronym
effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Scientific Title
effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Scientific Title:Acronym
effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Felipressin contained in the dental local anesthetic is a structural isomer of vasopressin. Vasopressin is clinically used for hemostasis utilizing the vasoconstrictor action, but its usefulness when added to dental local anesthesia is not clear. We examined the utility of lidocaine with vasopressin in rats. As a result, it was confirmed that low concentration vasopressin prolonged local anesthetic effect of lidocaine and did not affect circulation dynamics. This time for volunteers, we aim to study the anesthetic response time of vasopressin-added lidocaine and the influence on circulatory dynamics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure the anesthetic response time from 60 minutes after administration.
Key secondary outcomes
Measure blood pressure, pulse rate, percutaneous oxygen concentration from 60 minutes after administration.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers between 18 and 65 years old, ASA 2 degrees or less
Key exclusion criteria
When the target teeth are repaired with inactivated teeth, carious teeth, secondary cavities or more
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sunada Katsuhisa |
Organization
The Nippon Dental University
Division name
Dental Anesthesiology Course
Zip code
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
0332618311
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujimori Shoko |
Organization
The Nippon Dental University
Division name
Dental Anesthesiology Course
Zip code
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
0332618311
Homepage URL
shokosakura0805@gmail.com
Sponsor or person
Institute
The Nippon Dental University
Dental Anesthesiology Course
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
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
日本歯科大学歯科麻酔学講座研究室
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subject's first vital (pulse, blood pressure, percutaneous oxygen saturation) is measured and then the medication is administered. Electric stimulation is given to the test teeth at 2 minute intervals up to 10 minutes after administration and vital is measured. From 10 minutes onward, measure electric stimulus and vital every 5 minutes until 60 minutes.
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041057
