Ignite Creation Date:
2024-05-05 @ 9:48 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00963898
Status:
COMPLETED
Last Update Posted:
2009-08-24
First Post:
2009-08-20
Brief Title:
Accurate Controlled Dental Sedation
Sponsor:
Okayama University
Organization:
Okayama University
Study Overview
Official Title:
The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACDS
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None