Unique ID issued by UMIN | UMIN000011387 |
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Receipt number | R000013181 |
Scientific Title | A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study |
Date of disclosure of the study information | 2013/08/06 |
Last modified on | 2017/11/14 17:09:55 |
A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
Japan |
Dental Problem
Dental medicine |
Others
NO
The purpose of the present study is to evaluate whether capnography prevents patient's hypoxia during dental sedation for patients with intellectual disability.
Efficacy
Patient oxygen desaturation defined as a pulse oximetry reading of <= 95%
1) Patient oxygen desaturation defined as a pulse oximetry reading of <= 90%
2) Increasing total flow of oxygen
3) Artificial ventilation by bag valve mask
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Device,equipment |
In control group, observer gives the anesthesiologist advice to clear patient's airway when capnography show airway obstruction or apnea during 60s.
In intervention group, observer gives the anesthesiologist advice to clear patient's airway when capnography show airway obstruction or apnea during 15s.
16 | years-old | <= |
Not applicable |
Male and Female
1) Age 16 years or older.
2) Severe intellectual disability, and not cooperating fully with dental treatment.
3) American Society of Anesthesiologists (ASA) physical status 1 or 2.
1) ASA physical status 3 or over.
2) Preoperative value of pulse oximetry is under 95%.
3) Body mass index (BMI) is over 30.
4) Contraindication to midazolam or propofol.
246
1st name | |
Middle name | |
Last name | Takuya Miyawaki |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Dental Anesthesiology and Special Care Dentistry
2-5-1 Shikata-cho, Kita-ku, Okayama Japan
086-235-6721
miyawaki@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Hitoshi Higuchi |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Dental Anesthesiology and Special Care Dentistry
2-5-1 Shikata-cho, Kita-ku, Okayama Japan
086-235-6721
higuti@md.okayama-u.ac.jp
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama University
Other
Japan
NO
2013 | Year | 08 | Month | 06 | Day |
Unpublished
Completed
2013 | Year | 06 | Month | 25 | Day |
2013 | Year | 08 | Month | 06 | Day |
2015 | Year | 03 | Month | 31 | Day |
2013 | Year | 08 | Month | 06 | Day |
2017 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013181
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