UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036776 |
|---|---|
| Receipt number | R000041909 |
| Scientific Title | Effects of local anesthetic agents on sympatheic baroreflex sensitivity |
| Date of disclosure of the study information | 2019/05/16 |
| Last modified on | 2020/11/26 08:55:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of local anesthesia on blood pressure control
Acronym
LABRS
Scientific Title
Effects of local anesthetic agents on sympatheic baroreflex sensitivity
Scientific Title:Acronym
LABRS
Region
| Japan |
Condition
Condition
Dental disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether baroreflex sensitivity, as well as resting blood pressure, remains unchanged by using local ananesthetic agent without vasoconstrictor.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
baroreflex sensitivity
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy young-adult-male aged between 20 and 39.
Key exclusion criteria
Smoker
Those who have inflamation and/or pain sensation
Those who have mepivacaine allergy
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Ogasawara |
Organization
Matsumoto Dental University
Division name
Special Care Dentistry
Zip code
399-0781
Address
1780 Gobara, Hiro-oka, Shiojiri, Nagano, Japan
TEL
0263523100
tadashi.ogasawara@mdu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima University
Division name
Hospital
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5788
Homepage URL
okay@hiroshima-u.ac.jp
Sponsor or person
Institute
Matsumoto Dental University
Institute
Department
Personal name
Funding Source
Organization
Ryokufukai
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Boards of Matsumoto Dental University
Address
1780 Gobara, Hiro-oka, Shiojiri, Nagano, Japan
Tel
0263523100
info_kakenhi@mdu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 16 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will publicly recruit volunteer subjects between 10/1/2018 and 3/30/2023.
Management information
Registered date
| 2019 | Year | 05 | Month | 16 | Day |
Last modified on
| 2020 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041909
