UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023236 |
|---|---|
| Receipt number | R000026564 |
| Scientific Title | Effects of local anesthetics with adrenaline or felypressin on the QTc interval in elderly: a randomized double-blind crossover study. |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/01/15 13:01:06 |
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Basic information
Public title
Effects of local anesthetics with adrenaline or felypressin on the QTc interval in elderly: a randomized double-blind crossover study.
Acronym
The effect of local anesthetics with adrenalin or felypressin on the QTc interval in elderly
Scientific Title
Effects of local anesthetics with adrenaline or felypressin on the QTc interval in elderly: a randomized double-blind crossover study.
Scientific Title:Acronym
The effect of local anesthetics with adrenalin or felypressin on the QTc interval in elderly
Region
| Japan |
Condition
Condition
Elderly aged over 65 years
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to enhance the safety use of the local anesthetics with adrenaline or felypressin in a dental care of elderly by means of investigating the effect of that on the QTc interval.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QTc interval
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The intervention of this study is the administration of local anesthetics with adrenalin as an infiltration anesthesia
Interventions/Control_2
The intervention of this study is the administration of local anesthetics with felypressin as an infiltration anesthesia
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Elderly patients who visited Special care clinic-1 in Tokyo Medical and Dental University
2.Elderly patients undergoing two or more teeth extraction
3.Elderly patients with ASA physical status II-III
4.Elderly patients who are able to understand and subscribe to our informed consent
Key exclusion criteria
1. Elderly patient with a history of tachyarrhythmia
2. Elderly patient with severe renal or liver dysfunction.
3.Elderly patient with QT prolongation in the preoperative electrocardiogram
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Minakuchi |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5582
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Kyosaka |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate Schoo
Zip code
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5561
Homepage URL
shika.qq@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
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
| 2016 | Year | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 19 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026564
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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