Mental RetardationNCT01170377
Effect of Valproate on Propofol
An observational study of Mental Retardation, run by Okayama University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mental Retardation
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with mental reterdation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama
About this study
Official title: The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation
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.
Read the 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.
- Conditions
- Mental Retardation
- Keywords
- Intravenous sedation, Dental treatment, Mental retardation, Antiepileptic drug, Valproate, Propofol
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mental Retardation | Patients receiving valproate or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of anesthesia agent
Measured: 1 day
The recovery time of eyelash reflex
Measured: 1 day
The recovery time of eye opening
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startApr 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Investigators
- Minako Ishii, D.D.S., Principal investigator, Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170377
- Sponsor's protocol ID
- 141mina
- Status last verified
- Aug 2010
- First submitted
- 21 Jul 2010
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation
- ClinicalTrials.gov ID
- NCT01170377
- Acronym / sponsor ID
- 141mina
- Conditions
- Mental Retardation
- Keywords
- Intravenous sedation, Dental treatment, Mental retardation, Antiepileptic drug, Valproate, Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mental Retardation | – | –Patients receiving valproate or not |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with mental reterdation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The dose of anesthesia agent
Time frame: 1 day
The recovery time of eyelash reflex
Time frame: 1 day
The recovery time of eye opening
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minako Ishii, D.D.S. principal investigator
Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Retardation, run by Okayama University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose of anesthesia agent (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.