UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Acronym	Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Scientific Title	Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Scientific Title:Acronym	Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of hemodynamic alteration triggered by infiltration anesthesia using lidocaine with adrenaline
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SVR before and after using local anesthetic for dental use
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	15 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients planning dental treatment in the operating room of Showa University Dental Hospital
Key exclusion criteria	1) Patients with contraindications to anesthetics and local anesthetics used during surgery 2) Patients suffering from severe liver / kidney disorder or heart disease that may affect the operation 3) Patients judged to be ineligible based on the judgment of the doctor in charge 4) Patients who have not given consent for participation in this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name kanamrua Middle name Last name masako
Organization	showa university
Division name	Department of Perioperative Medicine,Division of Anesthesiology
Zip code	145-8515
Address	2-1-1 Kitasenzuka, Ota-ku, Tokyo
TEL	03-3787-1151
Email	ka76ra@dent.showa-u.ac.jp

Public contact
Name of contact person	1st name kanamura Middle name Last name masako
Organization	showa university
Division name	Department of Perioperative Medicine,Division of Anesthesiology
Zip code	145-8515
Address	2-1-1 Kitasenzuka, Ota-ku, Tokyo
TEL	03-3787-1151
Homepage URL
Email	ka76ra@dent.showa-u.ac.jp

Sponsor
Institute	showa university
Institute
Department

Funding Source
Organization	none
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	showa university
Address	2-1-1 Kitasenzuka, Ota-ku, Tokyo
Tel	03-3787-1151
Email	ka76ra@dent.showa-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	DH-2019-007
Org. issuing International ID_1	showa university
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 09 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	26
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	2019 Year 05 Month 27 Day
Date of IRB	2019 Year 05 Month 27 Day
Anticipated trial start date	2019 Year 05 Month 27 Day
Last follow-up date	2019 Year 05 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2019 Year 08 Month 10 Day
Last modified on	2019 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042946