UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025928 |
|---|---|
| Receipt number | 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 13:59:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ken2006anes@yahoo.co.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028869
