Accurate Controlled Dental Sedation

Not Applicable

Completed

• Conditions: Mental Retardation
• Interventions: Device: Target controlled infusion(TCI), Bispectral index(BIS)

• Registration Number: NCT00963898
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-04
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-08
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-21
• Last Update Submitted: 2009-08-21
• Study First Posted: 2009-08-24
• Last Update Posted: 2009-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mental Retardation	Target controlled infusion(TCI), Bispectral index(BIS)	-

Primary Outcome Measures

Name	Time	Method
The dose of anesthesia agent	1 day
The recovery times of eyelash reflex and eye opening	1 day
The time to going home	1 day

Trial Locations

Locations (1)

Department of Dental Anesthesiology, Okayama University Hospital; 🇯🇵 Okayama, Japan