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NCT01170377 Clinical Trial

Effect of Valproate on Propofol

Mental Retardation Clinical Trial

Official title:
The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01170377
Other study ID # 141mina
Secondary ID
Status Completed
Phase N/A
First received July 21, 2010
Last updated October 20, 2015
Start date April 2007
Est. completion date August 2010

Study information
Verified date August 2010
Source Okayama University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Observational

Clinical Trial 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.

Description:

The intravenous sedation with propofol is very useful for patients with mental retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedation depth because of the difficulty of verbal communication with them. Most of them have a epilepsy and take antiepileptic drugs. Antiepileptic drugs are thought to influence on the effect of anesthetics. Valproate is reported to inhibit the metabolism of propofol. Therefore, we divide the patients into two groups : patients receiving valproate (valproate group), patients receiving no antiepileptic drugs (control group), and compare the required dose of propofol and the recovery time.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

1. Patients aged 16 or over

2. American Society of Anesthesiologists (ASA) physical status 1 or 2

3. The treatment of dental caries, endodontics, periodontics and prosthesis were planed

4. Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria:

1. 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

2. Patients needed premedication and inhalational anesthetics

3. Patients had uncontrolled or sever medical condition

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama

Sponsors (1)
Lead Sponsor Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The dose of anesthesia agent 1 day Yes
Primary The recovery time of eyelash reflex 1 day Yes
Primary The recovery time of eye opening 1 day Yes
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