UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006228 |
|---|---|
| Receipt number | R000007374 |
| Scientific Title | The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation |
| Date of disclosure of the study information | 2011/08/25 |
| Last modified on | 2012/03/23 16:32:40 |
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Basic information
Public title
The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation
Acronym
Effect of Valproate on Propofol
Scientific Title
The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation
Scientific Title:Acronym
Effect of Valproate on Propofol
Region
| Japan |
Condition
Condition
Patients with oral valproate
Classification by specialty
| Neurology | Anesthesiology | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is well-known that antiepileptics influence drug-metabolizing enzymes . It has also been demonstrated in vitro that antiepileptics influence the metabolism of anesthetics. Particularly, carbamazepine has been reported to promote benzodiazepine metabolism by activating cytochrome P-450 (CYP). Valproate has been demonstrated to influence glucuronic acid conjugation and inhibit propofol metabolism, but, to our knowledge, no study has clinically demonstrated its influence. Thus, we hypothesized that oral valproate influences propofol pharmacokinetics and subsequently reduces the propofol dose required during anesthesia. The objective of our study was to investigate the clinical influence of oral valproate on the propofol dose required for sedation during dental treatment in patients with mental retardation. The clinical endpoint was set as the avoidance of complications assumed to be caused by the overdose of an anesthetic, propofol, or a delay in the recovery from anesthesia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The required dose of propofol
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
American Society of Anesthesiologists (ASA) physical status is 1 or 2.
The dental treatment plan had been prepared.
Patients had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment.
Key exclusion criteria
Patients can communicate and cooperate with dental treatment.
Patients need premedication and inhalational anesthetics.
ASA physical status is 3 or 4.
The complications are not controlled by oral drugs.
There is a tendency of somnolence before treatment due to the influence of medicine.
Patients have oral antiepileptic or psyhotropic drug medication excluding valproate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Miyawaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Siences
Division name
Department of Dental Anesthsiology and Special Care Dentistry
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minako ishii |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Siences
Division name
Department of Dental Anesthsiology and Special Care Dentistry
Zip code
Address
TEL
086-235-6721
Homepage URL
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Siences
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Siences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The required dose of propofol
The recovery time of eyelash reflex
The recovery time of eye opening
Management information
Registered date
| 2011 | Year | 08 | Month | 24 | Day |
Last modified on
| 2012 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007374
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
