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Accurate Controlled Dental Sedation (ACDS)

This study has been completed.
Information provided by:
Okayama University Identifier:
First received: August 20, 2009
Last updated: August 21, 2009
Last verified: August 2009
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 Retardation and challenging behavior.

Condition Intervention
Mental Retardation
Device: Target controlled infusion(TCI), Bispectral index(BIS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation

Resource links provided by NLM:

Further study details as provided by Okayama University:

Primary Outcome Measures:
  • The dose of anesthesia agent [ Time Frame: 1 day ]
  • The recovery times of eyelash reflex and eye opening [ Time Frame: 1 day ]
  • The time to going home [ Time Frame: 1 day ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mental Retardation Device: Target controlled infusion(TCI), Bispectral index(BIS)
Using TCI and BIS or not

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 maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participants aged 16 or over,
  2. American Society of Anesthesiologists (ASA) physical status 1 or 2
  3. The treatments of dental caries, endodontics, periodontics and prosthesis were planed
  4. Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria:

  1. 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,
  2. Patients needed premedication
  3. Patients had uncontrolled or sever medical condition
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Please refer to this study by its identifier: NCT00963898

Department of Dental Anesthesiology, Okayama University Hospital
Okayama, Japan, 700-8525
Sponsors and Collaborators
Okayama University
Principal Investigator: Hitoshi Higuchi, D.D.S., Ph.D Okayama University
  More Information

Responsible Party: Department of Dental Anesthesiology, Okayama University Hospital Identifier: NCT00963898     History of Changes
Other Study ID Numbers: 1104mai
Study First Received: August 20, 2009
Last Updated: August 21, 2009

Keywords provided by Okayama University:
Intravenous sedation
Target controlled infusion
Bispectral index
Dental treatment
Mental Retardation
Deep sedation

Additional relevant MeSH terms:
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders processed this record on April 28, 2017