UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027517 |
|---|---|
| Receipt number | R000031544 |
| Scientific Title | Swallowing ability and respiratory condition during intravenous sedation |
| Date of disclosure of the study information | 2017/05/28 |
| Last modified on | 2019/03/06 10:32:50 |
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Basic information
Public title
Swallowing ability and respiratory condition during intravenous sedation
Acronym
Swallowing ability and respiratory condition during intravenous sedation
Scientific Title
Swallowing ability and respiratory condition during intravenous sedation
Scientific Title:Acronym
Swallowing ability and respiratory condition during intravenous sedation
Region
| Japan |
Condition
Condition
healthy adult volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of intravenous sedation on swallowing ability and respiratory condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The volume of residualwater during swallowing test
Key secondary outcomes
Electromyogram during swallowing test, resipiratory rate, partial pressure of end tidal carbon dioxide
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous adminisitration of propofol using TCI pump. (copntrol, 0.5 microgram/ml, 1.0 microgram/ml, 1.5 microgram/ml)
Target concentration is increased after the swallowing test in each concentration. The period of total intervention is approximately 60 min.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
1. History of velopharyngeal insufficiency; palatal, pharyngeal or laryngeal surgery; speech or swallowing impairment; and trismus.
2. Contraindication of propofol
(1) History of allergic reaction to propofol, egg yolk or soybean
(2) Pregnancy or breast-feeding
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
+81-6-6879-2972
hanamoto@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
+81-6-6879-2972
Homepage URL
hanamoto@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 05 | Month | 28 | 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
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031544
