UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Swallowing ability and respiratory condition during intravenous sedation
Title of the study (Brief title)	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	Hiroshi Hanamoto
Organization	Osaka University Graduate School of Dentistry
Division name	Department of Dental Anesthesiology
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	Hiroshi Hanamoto
Organization	Osaka University Graduate School of Dentistry
Division name	Department of Dental Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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