UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027517
Receipt No. 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

* 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 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
Email 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
Email hanamoto@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031544

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.