Unique ID issued by UMIN | UMIN000007442 |
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Receipt number | 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 11:55:31 |
Objective evaluation for optimal dose of
dental anesthesia with Midazoram
Dental anesthesia with Midazoram
Objective evaluation for optimal dose of
dental anesthesia with Midazoram
Dental anesthesia with Midazoram
Japan |
Healthy male subjects
Dental medicine |
Others
NO
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.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
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)
1.Safety assessment (pulse oximeter:SpO2,
vital measurement,adverse event)
2.Plasma concentration of midazoram.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Initial dose: Midazoram I.v. 0.01mg/kg BW
Midazoram i.v. will be escalated with 0.01mg/kg BW if matched with criteria
20 | years-old | <= |
35 | years-old | >= |
Male
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.
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.
10
1st name | |
Middle name | |
Last name | Naoki UCHIDA |
Showa University School of Medicine
Department of Clinical Pharmacology
6-11-11 Kitakarasuyama, Setagaya-ku 157-8577 Tokyo
03-3300-5254
nuchida@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Naoki UCHIDA |
Showa University School of Medicine
Department of Clinical Pharmacology
6-11-11 Kitakarasuyama, Setagaya-ku 157-8577 Tokyo
03-3300-5254
nuchida@med.showa-u.ac.jp
Showa University School of Dentistry
Department of Comprehensive Dentistry
None
Self funding
Showa University School of Dentistry
Department of Clinical Cariology and Esthetic Dentistry Division
None
NO
昭和大学歯科病院(東京都)
2012 | Year | 03 | Month | 07 | Day |
Published
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.
Completed
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 07 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 05 | Day |
2016 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008721
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