Effect of Valproate on Propofol

Completed

• Conditions: Mental Retardation

• Registration Number: NCT01170377
• Lead Sponsor: Okayama University

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.

Detailed 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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The dose of anesthesia agent	1 day
The recovery time of eyelash reflex	1 day
The recovery time of eye opening	1 day

Trial Locations

Locations (1)

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