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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002589
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Akira Toyosato
Institute
Department

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
Email

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
URL(English) https://upload.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


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