UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006262 |
|---|---|
| Receipt number | R000007412 |
| Scientific Title | A research on complications and recovery time regarding to an ambulatory general anesthesia and an intravenous sedation for dental treatments on patients with intellectual disability. |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2015/07/17 20:13:12 |
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Basic information
Public title
A research on complications and recovery time regarding to an ambulatory general anesthesia and an intravenous sedation for dental treatments on patients with intellectual disability.
Acronym
A research on complications and recovery time regarding to an ambulatory general anesthesia and an intravenous sedation for dental treatments on patients with intellectual disability.
Scientific Title
A research on complications and recovery time regarding to an ambulatory general anesthesia and an intravenous sedation for dental treatments on patients with intellectual disability.
Scientific Title:Acronym
A research on complications and recovery time regarding to an ambulatory general anesthesia and an intravenous sedation for dental treatments on patients with intellectual disability.
Region
| Japan |
Condition
Condition
Intellectual disability
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objectives are patients with intellectual disability for whom ambulatory general anesthesia or intravenous sedation are planned. A purpose is to analyze relationship between various factors and complications as a cohort study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Background of patient: Age, gender, height, weight, cerebral palsy, autism, epilepsy, medicines of dairy use.
Anesthetic data: induction method, amount of midazolam, administration speed of propofol, recovery time.
Treatment data: treatment time, kinds of dental treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Objectives are patients with intellectual disability for whom ambulatory general anesthesia or intravenous sedation are planned from December 1st 2009 to March 31st 2012.
Key exclusion criteria
Patients without intellectual disability.
Target sample size
600
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 Parmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
0862356721
miyawaki@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Maeda |
Organization
Okayama University Graduate School of Medicine, Dentistry and Parmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
0862356721
Homepage URL
miyawaki@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Parmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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 | 09 | Month | 01 | 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
| 2011 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 31 | Day |
Other
Other related information
Cohort study
Management information
Registered date
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007412
