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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009754
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The Nippon Dental University Niigata Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011203

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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