UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009754 |
|---|---|
| Receipt number | R000011203 |
| Scientific Title | The safe medication method of the local analgesic in a circulatory organ system disease patient |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2013/01/11 10:00:43 |
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Basic information
Public title
The safe medication method of the local analgesic in a circulatory organ system disease patient
Acronym
The safe medication method of the local analgesic in a circulatory organ system disease patient
Scientific Title
The safe medication method of the local analgesic in a circulatory organ system disease patient
Scientific Title:Acronym
The safe medication method of the local analgesic in a circulatory organ system disease patient
Region
| Japan |
Condition
Condition
The circulatory organ disease patient needs dentistry minor surgery
(angina,hypertension)
Classification by specialty
| Cardiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Today,the local analgesic for dental care most generally used by the present and everyday clinical is 2% lidocaine with1 / 80,000 adrenalin.
However, with the dentistry medical examination for local anesthesia, such as tooth extraction by the hypertensive patient are increasing in number, is needed, the influence on blood pressure or circulation poses a problem.
This research is the purpose of adjusting a rapid change of hemodynamics, and examines the efficacy of the division injection route consists of preadministration of this medicine, and this administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1 Plasma catecholamine concentration
2 Hemodynamics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Only administration :Local infiltration anesthesia 3.0ml of 2%
lidocaine hydrochloride with 1:80,000 adrenalin
Interventions/Control_2
Preadministraion:Local infiltration anesthesia 0.5 ml of 2% lidocaine hydrochloride with 1: 80,000 adrenalin , after that, administraion:2.5 ml of 2%
lidocaine hydrochloride with 1:80,000 adrenalin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient the consent document about this research was got,among the patients have a circulatory organ system disease
Key exclusion criteria
Patient of three degree or more of ASA classification
Have a drug Allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Tsunokawa |
Organization
The Nippon Dental University Niigata Hospital
Division name
Dental Anesthesia
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Nippon Dental University Niigata Hospital
Division name
Dental Anesthesia
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
Homepage URL
Sponsor or person
Institute
The Nippon Dental University Niigata Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | 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
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
Preinitiation
Date of protocol fixation
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | 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
| 2013 | Year | 01 | Month | 11 | Day |
Last modified on
| 2013 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011203
