UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002589 |
|---|---|
| Receipt number | R000002723 |
| Scientific Title | Influence of the intravenous sedation on swallowing reflex |
| Date of disclosure of the study information | 2009/10/06 |
| Last modified on | 2009/12/21 17:38:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Influence of the intravenous sedation on swallowing reflex
Acronym
Intravenous sedation and swallowing reflex
Scientific Title
Influence of the intravenous sedation on swallowing reflex
Scientific Title:Acronym
Intravenous sedation and swallowing reflex
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect to swallowing reflex by anesthetic agents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A swallowing function in the sedative state after the administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
propofol group : 10
Interventions/Control_2
dexmedetomidine group : 10
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy person with normal swallowing reflex
Key exclusion criteria
No history of cardiovascular disease, pulmonary disease, neurological disease and allergy for soybean and egg.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Toyosato |
Organization
Kagoshima University Medical and Dental hospital
Division name
Dental Anesthesiology
Zip code
Address
Hachoume 35-1 Sakuragaoka Kagoshima City
TEL
099-275-6561
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Toyosato |
Organization
Kagoshima University Medical and Dental hospital
Division name
Dental Anesthesiology
Zip code
Address
Sakuragaoka Kagoshima City
TEL
099-275-6561
Homepage URL
Sponsor or person
Institute
Akira Toyosato
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (kakenhi)
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
| 2009 | Year | 10 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 06 | Day |
Last modified on
| 2009 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
