Back to resultsAccurate Controlled Dental Sedation (ACDS)
Primary Purpose
Mental Retardation
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Target controlled infusion(TCI), Bispectral index(BIS)
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Retardation focused on measuring Intravenous sedation, Target controlled infusion, Bispectral index, Dental treatment, Mental Retardation, Deep sedation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Department of Dental Anesthesiology, Okayama University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mental Retardation
Arm Description
Outcomes
Primary Outcome Measures
The dose of anesthesia agent
The recovery times of eyelash reflex and eye opening
The time to going home
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00963898
Brief Title
Accurate Controlled Dental Sedation
Acronym
ACDS
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 Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Okayama University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Retardation
Keywords
Intravenous sedation, Target controlled infusion, Bispectral index, Dental treatment, Mental Retardation, Deep sedation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mental Retardation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Target controlled infusion(TCI), Bispectral index(BIS)
Intervention Description
Using TCI and BIS or not
Primary Outcome Measure Information:
Title
The dose of anesthesia agent
Time Frame
1 day
Title
The recovery times of eyelash reflex and eye opening
Time Frame
1 day
Title
The time to going home
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hitoshi Higuchi, D.D.S., Ph.D
Organizational Affiliation
Okayama University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dental Anesthesiology, Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8525
Country
Japan
12. IPD Sharing Statement
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Accurate Controlled Dental Sedation
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