Unique ID issued by UMIN | UMIN000013448 |
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Receipt number | R000015594 |
Scientific Title | Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery |
Date of disclosure of the study information | 2014/03/19 |
Last modified on | 2018/08/29 11:32:51 |
Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Japan |
adult patients who need intravenous sedation for dental surgery
Dental medicine |
Others
NO
To investigate of clinical utility for conscious sedation by comparing dexmedetomidine sedation to propofol sedation.
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
unexpected patient movements
responsiveness, mouth opening time, cough reflex, snoring, total and rescue dose of midazolam, patient and operator satisfaction, memory of the procedure, recovery behaviour after sedation.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Medicine |
conscious sedation with midazolam (Dormicum) and dexmedetomidine (Precedex).
conscious sedation with midazolam (Dormicum) and propofol (Diprivan).
20 | years-old | <= |
80 | years-old | > |
Male and Female
adult patients who need conscious sedation for dental surgery
patients aged over 80; ASA physical status 3 and 4; patients with contraindications to propofol, dexmedetomidine and midazolam; allergy to soybean or egg; a history of cardiovascular or respiratory disease; use of drugs for psychotropic and cardiac desease.
88
1st name | |
Middle name | |
Last name | Hiroshi Hanamoto |
Osaka University Graduate School of Dentistry
Department of Dental Anesthesia
1-8, Yamadaoka, Suita City, Osaka, Japan
06-6879-2972
hanamoto@dent.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Hanamoto |
Osaka University Graduate School of Dentistry
Department of Dental Anesthesia
1-8, Tamadaoka, Suita City, Osaka, Japan
06-6879-2972
hanamoto@dent.osaka-u.ac.jp
Osaka University Graduate School of Dentistry
Osaka University Graduate School of Dentistry
none
NO
2014 | Year | 03 | Month | 19 | Day |
Published
https://www.sciencedirect.com/science/article/pii/S0278239118307614?via%3Dihub
Completed
2014 | Year | 02 | Month | 28 | Day |
2014 | Year | 05 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 18 | Day |
2018 | Year | 08 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015594
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