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