Effect of Valproate on Propofol

This study has been completed.
Information provided by:
Okayama University
ClinicalTrials.gov Identifier:
First received: July 21, 2010
Last updated: October 20, 2015
Last verified: August 2010
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.

Mental Retardation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation

Resource links provided by NLM:

Further study details as provided by Okayama University:

Primary Outcome Measures:
  • The dose of anesthesia agent [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • The recovery time of eyelash reflex [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • The recovery time of eye opening [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Mental Retardation
Patients receiving valproate or not

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.

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with mental reterdation

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01170377

Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama, Japan
Sponsors and Collaborators
Okayama University
Principal Investigator: Minako Ishii, D.D.S. Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  More Information

Responsible Party: Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT01170377     History of Changes
Other Study ID Numbers: 141mina 
Study First Received: July 21, 2010
Last Updated: October 20, 2015
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Okayama University:
Intravenous sedation
Dental treatment
Mental retardation
Antiepileptic drug

Additional relevant MeSH terms:
Intellectual Disability
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurodevelopmental Disorders
Neurologic Manifestations
Signs and Symptoms
Valproic Acid
Anesthetics, General
Anesthetics, Intravenous
Antimanic Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 23, 2016