UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036047
Receipt number R000041057
Scientific Title effects of Vasopressin on the anesthetic effect and hemodynamics of Lidocain
Date of disclosure of the study information 2019/03/31
Last modified on 2021/01/25 16:35:24

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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 or person

Institute

The Nippon Dental University
Dental Anesthesiology Course

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041057


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name