Status:
COMPLETED
Accurate Controlled Dental Sedation
Lead Sponsor:
Okayama University
Conditions:
Mental Retardation
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardatio...
Detailed Description
The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for ...
Eligibility Criteria
Inclusion
- Participants aged 16 or over,
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- The treatments of dental caries, endodontics, periodontics and prosthesis were planed
- Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment
Exclusion
- Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons,
- Patients needed premedication
- Patients had uncontrolled or sever medical condition
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00963898
Start Date
April 1 2007
End Date
August 1 2008
Last Update
August 24 2009
Active Locations (1)
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1
Department of Dental Anesthesiology, Okayama University Hospital
Okayama, Okayama-ken, Japan, 700-8525