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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005961
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007044

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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