UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011810 |
|---|---|
| Receipt number | R000013807 |
| Scientific Title | Effect of a local anesthetic on plasma catecholamine concentrations by the preliminary dose method for hypertension patient |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2013/09/19 17:07:40 |
* 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
Effect of a local anesthetic on plasma catecholamine concentrations by the preliminary dose method for hypertension patient
Acronym
Effect of a local anesthetic on plasma catecholamine concentrations by the preliminary dose method for hypertension patient
Scientific Title
Effect of a local anesthetic on plasma catecholamine concentrations by the preliminary dose method for hypertension patient
Scientific Title:Acronym
Effect of a local anesthetic on plasma catecholamine concentrations by the preliminary dose method for hypertension patient
Region
| Japan |
Condition
Condition
Hypertension patient to needs for minor surgery
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 with 1/80,000 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
Preadministration :Local infiltration anesthesia 0.5ml of 2% lidocaine hydrochloride with 1:80,000 adrenalin, after that, administration : 2.5ml 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 patient have a hypertension 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 | Kimito Sano |
Organization
The Nippon Dental University school of life Dentistry at Niigata
Division name
Dept of Dent Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
025-267-6477
sano@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimito Sano |
Organization
The Nippon Dental University school of life Dentistry at Niigata
Division name
Dept of Dent Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
025-267-6477
Homepage URL
sano@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University school of life Dentistry at Niigata
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 | 09 | Month | 20 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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 | 09 | Month | 19 | Day |
Last modified on
| 2013 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013807
