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Effect of Valproate on Propofol

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ClinicalTrials.gov Identifier: NCT01170377
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : October 21, 2015
Sponsor:
Information provided by:
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.

Condition or disease
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 Type : Observational
Estimated Enrollment : 50 participants
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
Study Start Date : April 2007
Primary Completion Date : August 2010
Study Completion Date : August 2010


Group/Cohort
Mental Retardation
Patients receiving valproate or not



Primary Outcome Measures :
  1. The dose of anesthesia agent [ Time Frame: 1 day ]
  2. The recovery time of eyelash reflex [ Time Frame: 1 day ]
  3. The recovery time of eye opening [ Time Frame: 1 day ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with mental reterdation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170377


Locations
Japan
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
Investigators
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

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
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: August 2010

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

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