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Completed

NCT Number: NCT01170377

Effect of Valproate on Propofol

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Okayama, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 16 or over
  • American Society of Anesthesiologists (ASA) physical status 1 or 2
  • The treatment of dental caries, endodontics, periodontics and prosthesis were planed
  • Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion criteria

  • 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
  • Patients needed premedication and inhalational anesthetics
  • Patients had uncontrolled or sever medical condition

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 27, 2010
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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