UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dexmedetomidine on the local anesthetic action
Title of the study (Brief title)	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	Kentaro Ouchi
Organization	Kyushu University
Division name	Dental science
Address	Fukuoka, Japan
TEL	092-641-1151
Email	ken2006anes@yahoo.co.jp

Public contact
Name of contact person	Kentaro Ouchi
Organization	Kyushu University
Division name	Dental science
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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