Accurate Controlled Dental Sedation (ACDS)

This study has been completed.

Sponsor:

Information provided by:

Okayama University

ClinicalTrials.gov Identifier:

NCT00963898

First received: August 20, 2009

Last updated: August 21, 2009

Last verified: August 2009

History of Changes

Purpose

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.

Condition	Intervention
Mental Retardation	Device: Target controlled infusion(TCI), Bispectral index(BIS)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care
Official Title:	The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation

Further study details as provided by Okayama University:

Primary Outcome Measures:

The dose of anesthesia agent [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The recovery times of eyelash reflex and eye opening [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The time to going home [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	April 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mental Retardation	Device: Target controlled infusion(TCI), Bispectral index(BIS) Using TCI and BIS or not

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants aged 16 or over,
American Society of Anesthesiologists (ASA) physical status 1 or 2
The treatments of dental caries, endodontics, periodontics and prosthesis were planed
Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria:

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,
Patients needed premedication
Patients had uncontrolled or sever medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963898

Locations

Japan
Department of Dental Anesthesiology, Okayama University Hospital
Okayama, Japan, 700-8525

Sponsors and Collaborators

Okayama University

Investigators

Principal Investigator:

Hitoshi Higuchi, D.D.S., Ph.D

Okayama University

More Information

No publications provided

Responsible Party:	Department of Dental Anesthesiology, Okayama University Hospital
ClinicalTrials.gov Identifier:	NCT00963898 History of Changes
Other Study ID Numbers:	1104mai
Study First Received:	August 20, 2009
Last Updated:	August 21, 2009
Health Authority:	Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Okayama University:

Intravenous sedation
Target controlled infusion
Bispectral index

Dental treatment
Mental Retardation
Deep sedation

Additional relevant MeSH terms:

Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013

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