UMIN-CTR Clinical Trial

Basic information
Public title	effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Acronym	effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Scientific Title	effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Scientific Title:Acronym	effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Felipressin contained in the dental local anesthetic is a structural isomer of vasopressin. Vasopressin is clinically used for hemostasis utilizing the vasoconstrictor action, but its usefulness when added to dental local anesthesia is not clear. We examined the utility of lidocaine with vasopressin in rats. As a result, it was confirmed that low concentration vasopressin prolonged local anesthetic effect of lidocaine and did not affect circulation dynamics. This time for volunteers, we aim to study the anesthetic response time of vasopressin-added lidocaine and the influence on circulatory dynamics.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measure the anesthetic response time from 60 minutes after administration.
Key secondary outcomes	Measure blood pressure, pulse rate, percutaneous oxygen concentration from 60 minutes after administration.

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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult volunteers between 18 and 65 years old, ASA 2 degrees or less
Key exclusion criteria	When the target teeth are repaired with inactivated teeth, carious teeth, secondary cavities or more
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Sunada Katsuhisa
Organization	The Nippon Dental University
Division name	Dental Anesthesiology Course
Zip code
Address	1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL	0332618311
Email	katsu.sunada@nifty.com

Public contact
Name of contact person	1st name Middle name Last name Fujimori Shoko
Organization	The Nippon Dental University
Division name	Dental Anesthesiology Course
Zip code
Address	1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL	0332618311
Homepage URL
Email	shokosakura0805@gmail.com

Sponsor
Institute	The Nippon Dental University Dental Anesthesiology Course
Institute
Department

Funding Source
Organization	The Nippon Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JPN

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	日本歯科大学歯科麻酔学講座研究室

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 31 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	2019 Year 02 Month 22 Day
Date of IRB	2019 Year 02 Month 22 Day
Anticipated trial start date	2019 Year 02 Month 22 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The subject's first vital (pulse, blood pressure, percutaneous oxygen saturation) is measured and then the medication is administered. Electric stimulation is given to the test teeth at 2 minute intervals up to 10 minutes after administration and vital is measured. From 10 minutes onward, measure electric stimulus and vital every 5 minutes until 60 minutes.

Management information
Registered date	2019 Year 02 Month 28 Day
Last modified on	2021 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041057