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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029715
Receipt No. 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 2017/10/25

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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
Middle name
Last name Ryo Wakita
Organization Division of oral health scienses, Graduate school, Tokyo Medical and Dental University
Division name Section of Anesthesiology and Clinical Physiology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5549
Email ryoanph@tmd.ac.jp

Public contact
Name of contact person
1st name
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
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5549
Homepage URL
Email ryoanph@tmd.ac.jp

Sponsor
Institute Section of Anesthesiology and Clinical Physiology, Division of Oral Health Sciences, Graduate School, Tokyo Medical and Dental University
Institute
Department

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
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
2017 Year 10 Month 27 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
2017 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 25 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 10 Month 25 Day
Last modified on
2017 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033172

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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