Trial record 15 of 20 for:    Open Studies | "Dental Care"

Effect of Valproate on Propofol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Okayama University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Okayama University
ClinicalTrials.gov Identifier:
NCT01170377
First received: July 21, 2010
Last updated: July 26, 2010
Last verified: July 2010
  Purpose

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
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
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Minako Ishii, D.D.S. 81-86-235-6721 ishii-m@md.okayama-u.ac.jp
Contact: Takuya Miyawaki, D.D.S., Ph.D 81-86-235-6721 miyawaki@md.okayama-u.ac.jp

Locations
Japan
Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Recruiting
Okayama, Japan
Contact: Minako Ishii, D.D.S.    81-86-235-6721    ishii-m@md.okayama-u.ac.jp   
Contact: Takuya Miyawaki, D.D.S, Ph.D    81-86-235-6721    miyawaki@md.okayama-u.ac.jp   
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
  More Information

No publications provided

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: July 26, 2010
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Valproic Acid
Propofol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 21, 2014