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
Recruitment status was Recruiting
Sponsor:
Okayama University
Information provided by:
Okayama University
ClinicalTrials.gov Identifier:
NCT01170377
First received: July 21, 2010
Last updated: July 26, 2010
Last verified: July 2010
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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:
- 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
Contacts and Locations
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:
|
Mental Retardation 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 Anesthetics, Intravenous Anesthetics, General Anesthetics Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on October 17, 2012
