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
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
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
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
