UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029715 |
|---|---|
| Receipt number | R000033172 |
| Scientific Title | The time dependent change of cardiac function by infiltration anesthesia in oral mucosa |
| Date of disclosure of the study information | 2017/10/27 |
| Last modified on | 2021/10/29 19:59:41 |
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Basic information
Public title
The time dependent change of cardiac function by infiltration anesthesia in oral mucosa
Acronym
The change of cardiac function by infiltration anesthesia
Scientific Title
The time dependent change of cardiac function by infiltration anesthesia in oral mucosa
Scientific Title:Acronym
The change of cardiac function by infiltration anesthesia
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of the cardiac function by the epinephrine contained with infiltration anesthetics
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Increase of cardiac output, and prolongation of increasing time of cardiac output
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Infiltration local anesthesia to the oral mucosa is performed by using 3.6ml of 2% lidocaine containing with 1/73,000 epinephrine bitartrate. This study is performed for two consecutive days. The anesthetic in day two is different from that in day one. The cardiac functions are collected for about 60 min after local anesthesia.
Interventions/Control_2
Infiltration local anesthesia to the oral mucosa is performed by using 3.6ml of 2% lidocaine. This study is performed for two consecutive days. The anesthetic in day two is different from that in day one. The cardiac functions are collected for about 60 min after local 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
subjects are healthy young adult (AHA physical status I)
Key exclusion criteria
criteria is as follows
# allergic for the local anesthesia
# subjects who used steroids within a week
# subjects who used any pain reliever within a week
# subjects who have histories of discomfort at local anesthesia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Wakita |
Organization
Division of oral health scienses, Graduate school, Tokyo Medical and Dental University
Division name
Section of Anesthesiology and Clinical Physiology
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5549
ryoanph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ryo Wakita |
Organization
Division of Oral Health Sciences, Graduate School, Tokyo Medical and Dental University
Division name
Section of Anesthesiology and Clinical Physiology
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5549
Homepage URL
ryoanph@tmd.ac.jp
Sponsor or person
Institute
Section of Anesthesiology and Clinical Physiology, Division of Oral Health Sciences, Graduate School, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Section of Anesthesiology and Clinical Physiology, Division of Oral Health Sciences, Graduate School, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Dentistry Ethics Committee
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.jp
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 | 10 | Month | 27 | Day |
Related information
URL releasing protocol
https://web-ura.tmd.ac.jp/rinri/Apply/project.aspx?PROJECT_ID=2403
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2667147621000911
Number of participants that the trial has enrolled
8
Results
The cardiac index and heart rate increased by 40% in group AD. Moreover, the cardiac index and systemic vascular resistance index in group AD required 50？min to recover to the pre-injection levels. Heart rate variations showed no intergroup differences, and variations in systolic continuous blood pressure persisted for only 30？min. The effect of anaesthetic injection containing adrenaline on cardiac function may persist even after the vital signs return to normal.
Results date posted
| 2021 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adult volunteers were recruited
Participant flow
All participants have explained the importance of and the risks associated with this study and provided informed consent before the study began. Participants with allergies to local anaesthetics, a history of steroid or analgesic use, or a history of unpleasant feelings during infiltration anaesthesia were excluded. In addition, participants considered to be unsuitable for local anaesthesia by dentists were also excluded.
Adverse events
N/A
Outcome measures
cardiac parameters, including cardiac index, stroke volume, systemic vascular resistance index, continuous blood pressure, and heart rate,
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033172
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