Accurate Controlled Dental Sedation

Mental Retardation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963898
• Other study ID #: 1104mai
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: August 21, 2009
• Start date: April 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2009
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intellectual Disability
• Mental Retardation

Intervention

Device:
• Target controlled infusion(TCI), Bispectral index(BIS)
Using TCI and BIS or not

Locations

Country	Name	City	State
Japan	Department of Dental Anesthesiology, Okayama University Hospital	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dose of anesthesia agent		1 day	No
Primary	The recovery times of eyelash reflex and eye opening		1 day	No
Primary	The time to going home		1 day	No