Mental RetardationACDSNCT00963898
Accurate Controlled Dental Sedation
A study of Mental Retardation, run by Okayama University at 1 site in Japan.
Trial summary
The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mental Retardation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Aug 2008
- Phase
- Interventional
- 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
Who may be able to join
- Participants aged 16 or over,
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- The treatments 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
- Patients had uncontrolled or sever medical condition
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Dental Anesthesiology, Okayama University Hospital
Okayama, Okayama-ken, 700-8525
About this study
Official title: The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation
The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.
Read the detailed description
The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.
- Conditions
- Mental Retardation
- Being tested
- Target controlled infusion(TCI), Bispectral index(BIS)
- Keywords
- Intravenous sedation, Target controlled infusion, Bispectral index, Dental treatment, Mental Retardation, Deep sedation
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target controlled infusion(TCI), Bispectral index(BIS)Device
Using TCI and BIS or not
| Study group | Role | What they receive |
|---|---|---|
| Mental Retardation | Experimental | Not described Receives: Device: Target controlled infusion(TCI), Bispectral index(BIS) |
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 times of eyelash reflex and eye opening
Measured: 1 day
The time to going home
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 posted24 Aug 2009 (estimated)
- Study startApr 2007
- Primary completionAug 2008
- Study completionAug 2008
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Investigators
- Hitoshi Higuchi, D.D.S., Ph.D, Principal investigator, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963898
- Sponsor's protocol ID
- 1104mai
- Acronym
- ACDS
- Status last verified
- Aug 2009
- First submitted
- 20 Aug 2009
- Last updated
- 24 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation
- ClinicalTrials.gov ID
- NCT00963898
- Acronym / sponsor ID
- ACDS / 1104mai
- Conditions
- Mental Retardation
- Keywords
- Intravenous sedation, Target controlled infusion, Bispectral index, Dental treatment, Mental Retardation, Deep sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Aug 2009 (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 benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.
Detailed description
The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mental Retardation | Experimental | Device: Target controlled infusion(TCI), Bispectral index(BIS) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 16 or over,
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- The treatments 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
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target controlled infusion(TCI), Bispectral index(BIS)Using TCI and BIS or not | Device | Mental Retardation |
Primary outcome
The dose of anesthesia agent
Time frame: 1 day
The recovery times of eyelash reflex and eye opening
Time frame: 1 day
The time to going home
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 24 Aug 2009.
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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.
Hitoshi Higuchi, D.D.S., Ph.D principal investigator
Okayama University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A 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 24 Aug 2009. 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 24 Aug 2009.