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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007442
Receipt No. R000008721
Scientific Title Objective evaluation for optimal dose of dental anesthesia with Midazoram
Date of disclosure of the study information 2012/03/07
Last modified on 2016/04/09

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Basic information
Public title Objective evaluation for optimal dose of
dental anesthesia with Midazoram
Acronym Dental anesthesia with Midazoram
Scientific Title Objective evaluation for optimal dose of
dental anesthesia with Midazoram
Scientific Title:Acronym Dental anesthesia with Midazoram
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the optimum dose of dental anesthesia with Midazoram i.v. for sufficient anesthetic action not lead up to deeper sedation evaluated by subjective and objective evaluation and safety assessment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1.The anesthetic action after Midazolam i.v.(vomiting reflex,saliva production,
mouth open)
2.The sedative action after Midazolam i.v.(subjective evaluation:VAS,objective
evaluation:auditory evoked potential)
Key secondary outcomes 1.Safety assessment (pulse oximeter:SpO2,
vital measurement,adverse event)
2.Plasma concentration of midazoram.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Initial dose: Midazoram I.v. 0.01mg/kg BW

Midazoram i.v. will be escalated with 0.01mg/kg BW if matched with criteria
Interventions/Control_2
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
35 years-old >=
Gender Male
Key inclusion criteria 1.Subjects are competent to cosent,Keep the rules of the study and are able to report self-codition.
2.Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Key exclusion criteria 1.Subjects who have an inappropriate clinical history for efficacy and safety
assessment in the study(such as drug poisoning,alcoholism,and the disease of heart,liver,kidney,lungs,eye,blood etc)
and who is taking any drugs (including health supplements).
2.smokers.
3.Any history for drug allergy.
4.Subjects who are taking in too much alcohol.
5.Subjects who are nocturnal life.
6.Subjects within three months after the
participation to other clinical traials.
7.Subjects who are inadequate for enrollment judged by the investigator.





Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki UCHIDA
Organization Showa University School of Medicine
Division name Department of Clinical Pharmacology
Zip code
Address 6-11-11 Kitakarasuyama, Setagaya-ku 157-8577 Tokyo
TEL 03-3300-5254
Email nuchida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki UCHIDA
Organization Showa University School of Medicine
Division name Department of Clinical Pharmacology
Zip code
Address 6-11-11 Kitakarasuyama, Setagaya-ku 157-8577 Tokyo
TEL 03-3300-5254
Homepage URL
Email nuchida@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Dentistry
Department of Comprehensive Dentistry
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Showa University School of Dentistry
Department of Clinical Cariology and Esthetic Dentistry Division
Name of secondary funder(s) None

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 昭和大学歯科病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
MDZ dose accumulation over 0.04 mg/kg BW reduced mouth opening capacity and vomiting reflex. MDZ dose accumulation over 0.05 mg/kg BW reduced the quantity of salivation. Using the VAS level,a peak in the sedative effect occurred at 0.06 mg/kg BW. Using the auditory evoked potentials monitor,the epoch that were optimal sedation increased at 0.03-0.06 mg/kg BW. These result suggested that an MDZ dose of 0.06 mg/kg BW was suitable for sedation in dental treatment. The result of this investigation can be applied as the index of intravenous sedation in clinics more effectively.
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
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 07 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2014 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 05 Day
Last modified on
2016 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008721

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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