NCT00963898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
Last Updated

August 24, 2009

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

August 20, 2009

Last Update Submit

August 21, 2009

Conditions

Mental Retardation

Keywords

Intravenous sedationTarget controlled infusionBispectral indexDental treatmentMental RetardationDeep sedation

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Mental Retardation

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

Interventions

Target controlled infusion(TCI), Bispectral index(BIS)DEVICE

Using TCI and BIS or not

Mental Retardation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dental Anesthesiology, Okayama University Hospital

Okayama, Okayama-ken, 700-8525, Japan

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hitoshi Higuchi, D.D.S., Ph.D

    Okayama University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 24, 2009

Study Start

April 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 24, 2009

Record last verified: 2009-08

Locations

JP(1)