UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028294 |
|---|---|
| Receipt number | R000032290 |
| Scientific Title | A study on effectiveness of local anesthetic injected by the pre-administration method in tooth extracted patients with essential hypertension |
| Date of disclosure of the study information | 2017/07/20 |
| Last modified on | 2017/07/20 08:26:21 |
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Basic information
Public title
A study on effectiveness of local anesthetic injected by the pre-administration method in tooth extracted patients with essential hypertension
Acronym
A study on local anesthetic injected by the pre-administration method for patients with essential hypertension
Scientific Title
A study on effectiveness of local anesthetic injected by the pre-administration method in tooth extracted patients with essential hypertension
Scientific Title:Acronym
A study on local anesthetic injected by the pre-administration method for patients with essential hypertension
Region
| Japan |
Condition
Condition
Periodontitis
Essential hypertension
Classification by specialty
| Cardiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of divided administration of local anesthesia on the circulatory dynamics of essential hypertension patients at tooth extraction and examine its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
systolic blood pressure 1, 2, 3, 4, 5, 10 minutes after local anesthetic administration
Key secondary outcomes
diastolic blood pressure
pulse rate
rate pressure product
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1 group: 2% lidocaine with 1/80,000 adrenaline 2.3 ml administration
Interventions/Control_2
2 group: 2% lidocaine with 1/80,000 adrenaline 0.5 ml pre-administration, 1.8 ml administration after 5 minutes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Extraction is planned and adult patients with essential hypertension being treated
Key exclusion criteria
Patient taking medication contraindicated with adrenaline
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Akashiba |
Organization
The Nippon Dental University Niigata Hospital
Division name
Oral and Maxillofacial Surgery
Zip code
Address
1-8 Hamaura-cho, Chuo-ku Niigata , 951-8151, Japan
TEL
025-267-1500
aka@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Akashiba |
Organization
The Nippon Dental University Niigata Hospital
Division name
Oral and Maxillofacial Surgery
Zip code
Address
1-8 Hamaura-cho, Chuo-ku Niigata , 951-8151, Japan
TEL
025-267-1500
Homepage URL
aka@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University Niigata Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2017 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | 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
| 2017 | Year | 07 | Month | 20 | Day |
Last modified on
| 2017 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032290
