NCT01170377

Brief Summary

The aim of this study is to evaluate the effect of valproate on the required dose of propofol for sedation in patients with mental retardation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 21, 2015

Status Verified

August 1, 2010

Enrollment Period

3.3 years

First QC Date

July 21, 2010

Last Update Submit

October 20, 2015

Conditions

Mental Retardation

Keywords

Intravenous sedationDental treatmentMental retardationAntiepileptic drugValproatePropofol

Outcome Measures

Primary Outcomes (3)

  • The dose of anesthesia agent

    1 day

  • The recovery time of eyelash reflex

    1 day

  • The recovery time of eye opening

    1 day

Study Arms (1)

Mental Retardation

Patients receiving valproate or not

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with mental reterdation

You may qualify if:

  • Patients aged 16 or over
  • American Society of Anesthesiologists (ASA) physical status 1 or 2
  • The treatment 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 and inhalational anesthetics
  • Patients had uncontrolled or sever medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Okayama, 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

  • Minako Ishii, D.D.S.

    Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 27, 2010

Study Start

April 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 21, 2015

Record last verified: 2010-08

Locations

JP(1)