Accurate Controlled Dental Sedation (ACDS)

Okayama University

Status: Completed

Conditions: Mental Retardation

Treatments: Device: Target controlled infusion(TCI), Bispectral index(BIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00963898

1104mai

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 1 patient group

Mental Retardation

Experimental group

Treatment:

Device: Target controlled infusion(TCI), Bispectral index(BIS)