Effect of Valproate on Propofol

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01170377

Enrollment

Registered

2010-07-27

Start date

2007-04-30

Completion date

2010-08-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Retardation

Keywords

Intravenous sedation, Dental treatment, Mental retardation, Antiepileptic drug, Valproate, Propofol

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The dose of anesthesia agent	1 day
The recovery time of eyelash reflex	1 day
The recovery time of eye opening	1 day

Countries

Japan

Outcome results