UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005961 |
|---|---|
| Receipt number | R000007044 |
| Scientific Title | Effect of dexmedetomidine on the local anesthetic action and the circulatory system |
| Date of disclosure of the study information | 2011/07/11 |
| Last modified on | 2012/09/28 09:55:48 |
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Basic information
Public title
Effect of dexmedetomidine on the local anesthetic action and the circulatory system
Acronym
Effect of dexmedetomidine on the local anesthetic action and the circulatory system
Scientific Title
Effect of dexmedetomidine on the local anesthetic action and the circulatory system
Scientific Title:Acronym
Effect of dexmedetomidine on the local anesthetic action and the circulatory system
Region
| Japan |
Condition
Condition
Healthy body
Classification by specialty
| 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 reduce the harmful influences.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring the local perception using Pain Vision(R) and blood pressure, heart rate,arrhythmia,and oxygen saturation as measured using pulse oximetry.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We inject with 0.7% Lidocaine solution(EC50)1ml under the mouth mucosa.And we measure the local perception using Pain Vision(R) and blood pressure, heart rate,arrhythmia,and oxygen saturation as measured using pulse oximetry every 10 minutes until 120 minutes.
Interventions/Control_2
We inject with 0.7% Lidocaine solution with dexmedetomidine10-6M 1ml under the mouth mucosa. And we measure the local perception using Pain Vision(R) and bloodpressure,heartrate,arrhythmia,and oxygen saturation as measured using pulse oximetry every 10 minutes until 120 minutes.
Interventions/Control_3
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy body.
Student and ataff of okayama university hospital with agreement.
Key exclusion criteria
1. hypersensitivity
2. hypertension,diabetes,
hyperthyroidism,arteriosclerosis
3. dyshepatia,dysnephria
4. cardiovascular disease
5. serious arrhythmia
6. taking antipsychotic drugs or alfa-blocker
7. taking catecholamine drugs or adrenergic drugs
8. sensitive to sympathomimetic drugs
9. psychoneurosis or cocaine poisoning
10. dental phobia
11. a pregnant woman or the lactation period
12. a researcher think unsuitable
13. hypertension or arrhythmia at history taking
14. taking medicine
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Miyawaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
5-1,Shikata-chou 2-choume,Kita-ku,Okayama,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
5-1,Shikata-chou 2-choume,Kita-ku,Okayama,Japan
TEL
Homepage URL
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 20 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 11 | Day |
Last modified on
| 2012 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007044
