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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025928
Receipt No. R000028869
Scientific Title Effect of dexmedetomidine on the local anesthetic action
Date of disclosure of the study information 2017/02/01
Last modified on 2018/12/28

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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
Anesthesiology Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation the effect of Dexmedetomidine with lidocaine increase the local anesthetic action and the cardiovascular influences.
Basic objectives2 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 Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 lidocaine with dexmedetomidine of some density
Interventions/Control_2 lidocaine with dexmedetomidine of some density
Interventions/Control_3 lidocaine with adrenaline
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
19 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy body.
Student and staff with agreement.
Key exclusion criteria Patient of two degree or more of ASAclassification
Have a drug Allergy
Target sample size 19

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Ouchi
Organization Kyushu University
Division name Dental science
Zip code
Address Fukuoka, Japan
TEL 092-641-1151
Email ken2006anes@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Ouchi
Organization Kyushu University
Division name Dental science
Zip code
Address Fukuoka, Japan
TEL 092-641-1151
Homepage URL
Email ken2006anes@yahoo.co.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Kyushu University
The clinical Research Promotion foundation
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 02 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
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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 31 Day
Last modified on
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028869

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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