Mental Retardation
Conditions
Keywords
Intravenous sedation, Target controlled infusion, Bispectral index, Dental treatment, Mental Retardation, Deep sedation
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.
Interventions
DEVICETarget controlled infusion(TCI), Bispectral index(BIS)
Using TCI and BIS or not
Sponsors
Okayama University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed