UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016224
Receipt number R000018831
Scientific Title Effect of dexmedetomidine on the local anesthetic action
Date of disclosure of the study information 2015/01/15
Last modified on 2018/12/06 09:14:34

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Basic information

Public title

Effect of dexmedetomidine on the local anesthetic action

Acronym

Effect of dexmedetomidine on the local anesthetic action

Scientific Title

Effect of dexmedetomidine on the local anesthetic action

Scientific Title:Acronym

Effect of dexmedetomidine on the local anesthetic action

Region

Japan


Condition

Condition

Healthy body

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation the effect of Dexmedetomidine with lidocaine increase the local anesthetic action and reduce the cardiovascular influences.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Anesthesia success rate
Onset of anesthesia
Pulp chamber anesthesia success rate
Unpleasant frequency at the time of infusion of drug
Vital signs
Sedation score

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

lidocaine with 1:80000 adrenaline

Interventions/Control_2

lidocaine with dexmedetomidine of some density

Interventions/Control_3

lidocaine with dexmedetomidine of some density

Interventions/Control_4

lidocaine with dexmedetomidine of some density

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy body.
Student and staff of kagoshima university hospital with agreement.

Key exclusion criteria

Patient of two degree or more of ASAclassification
Have a drug Allergy

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kentaro Ouchi

Organization

Kagoshima University

Division name

Anesthesia center

Zip code


Address

8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN

TEL

099-275-5111

Email

ken2006anes@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro OUCHI

Organization

Kagoshima University

Division name

Anesthesia center

Zip code


Address

8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN

TEL

099-275-5111

Homepage URL


Email

ken2006anes@yahoo.co.jp


Sponsor or person

Institute

Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

Kagoshima 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

鹿児島大学医学部・歯学部附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 15 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

No longer recruiting

Date of protocol fixation

2014 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 01 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

2015 Year 01 Month 15 Day

Last modified on

2018 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018831


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name