UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012882 |
|---|---|
| Receipt number | R000015052 |
| Scientific Title | Required propofol dose and time to emerge for anesthesia, affect by antiepileptics and disability |
| Date of disclosure of the study information | 2014/01/18 |
| Last modified on | 2015/06/09 13:56:08 |
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Basic information
Public title
Required propofol dose and time to emerge for anesthesia, affect by antiepileptics and disability
Acronym
The propofol required dose and the emergence in intravenous sedation for patient with disability
Scientific Title
Required propofol dose and time to emerge for anesthesia, affect by antiepileptics and disability
Scientific Title:Acronym
The propofol required dose and the emergence in intravenous sedation for patient with disability
Region
| Japan |
Condition
Condition
patients with neurological disorder who were treated under intravenous general anesthesia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the present study was to investigate the relationship between number of used antiepileptics and the propofol dose required for anesthesia and the time to emerge from anesthesia during dental treatment in patients with neurological disorders. We also investigated these parameters in relation to type of antiepileptics and relation to disability.
We examine a dose and the emergence of the anesthetic in the intravenous sedation according to the kind of the disability.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure predictive blood concentration, time for emergence and propofol dose.
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient that an agreement was provided
Key exclusion criteria
The cases that did not use TCI and BIS or did not consent of study were excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Ouchi |
Organization
Kagoshima university hospital
Division name
Anesthesia center
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL
099-275-5111
ken2006anes@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro OUCHI |
Organization
Kagoshima University
Division name
Anesthesia center
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL
099-275-5111
Homepage URL
ken2006anes@yahoo.co.jp
Sponsor or person
Institute
Kagoshima university
Institute
Department
Personal name
Funding Source
Organization
Kagoshima university
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
| 2014 | Year | 01 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
propofol dose required for anesthesia, time to emergence, and modelled propofol blood concentration at emergence were evaluated.
Management information
Registered date
| 2014 | Year | 01 | Month | 17 | Day |
Last modified on
| 2015 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015052
