NCT00963898

Accurate Controlled Dental Sedation

The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Okayama University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mental Retardation

Interventions

Type	Name	Description
DEVICE	Target controlled infusion(TCI), Bispectral index(BIS)	Using TCI and BIS or not

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2009-08-24
• Last updated: 2009-08-24

Locations

1 site across 1 country: Japan