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Accurate Controlled Dental Sedation (ACDS)

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ClinicalTrials.gov Identifier: NCT00963898
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : August 24, 2009
Sponsor:
Information provided by:
Okayama University

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 Retardation and challenging behavior.

Condition or disease Intervention/treatment Phase
Mental Retardation Device: Target controlled infusion(TCI), Bispectral index(BIS) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : April 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mental Retardation Device: Target controlled infusion(TCI), Bispectral index(BIS)
Using TCI and BIS or not



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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963898


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

Responsible Party: Department of Dental Anesthesiology, Okayama University Hospital
ClinicalTrials.gov Identifier: NCT00963898     History of Changes
Other Study ID Numbers: 1104mai
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: August 24, 2009
Last Verified: August 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