UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037660 |
|---|---|
| Receipt number | R000042946 |
| Scientific Title | Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/10 16:59:58 |
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Basic information
Public title
Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Acronym
Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Scientific Title
Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Scientific Title:Acronym
Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SVR before and after using local anesthetic for dental use
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
| 15 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients planning dental treatment in the operating room of Showa University Dental Hospital
Key exclusion criteria
1) Patients with contraindications to anesthetics and local anesthetics used during surgery
2) Patients suffering from severe liver / kidney disorder or heart disease that may affect the operation
3) Patients judged to be ineligible based on the judgment of the doctor in charge
4) Patients who have not given consent for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kanamrua |
| Middle name | |
| Last name | masako |
Organization
showa university
Division name
Department of Perioperative Medicine,Division of Anesthesiology
Zip code
145-8515
Address
2-1-1 Kitasenzuka, Ota-ku, Tokyo
TEL
03-3787-1151
ka76ra@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | kanamura |
| Middle name | |
| Last name | masako |
Organization
showa university
Division name
Department of Perioperative Medicine,Division of Anesthesiology
Zip code
145-8515
Address
2-1-1 Kitasenzuka, Ota-ku, Tokyo
TEL
03-3787-1151
Homepage URL
ka76ra@dent.showa-u.ac.jp
Sponsor or person
Institute
showa university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
showa university
Address
2-1-1 Kitasenzuka, Ota-ku, Tokyo
Tel
03-3787-1151
ka76ra@dent.showa-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
DH-2019-007
Org. issuing International ID_1
showa university
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 | 09 | Month | 01 | 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
26
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 | 05 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 08 | Month | 10 | Day |
Last modified on
| 2019 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042946
