UMIN-CTR Clinical Trial

Basic information
Public title	Prospective evaluation for Propofol sedation in screening endoscopy
Acronym	Propofol evaluation
Scientific Title	Prospective evaluation for Propofol sedation in screening endoscopy
Scientific Title:Acronym	Propofol evaluation
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Propofol has expectedly been a good drug for sedation. In an outpatient setting, safety and satisfaction of propofol sedation have not been fully evaluated.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of propofol sedation
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	screening endoscopy using propofol
Key exclusion criteria	no written consent
Target sample size	2300

Research contact person
Name of lead principal investigator	1st name Yoshihide Middle name Last name Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	983-0824
Address	5-22-1, Tsurugaya, Miyagino-ku
TEL	022-252-1111
Email	yoshi-hk@openhp.or.jp

Public contact
Name of contact person	1st name Yoshihide Middle name Last name Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	983-0824
Address	5-22-1, Tsurugaya, Miyagino-ku
TEL	022-252-1111
Homepage URL
Email	yoshi-hk@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center
Institute
Department

Funding Source
Organization	Self-funding
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	Sendai City Medical Center
Address	5-22-1, Tsurugaya, Miyagino-ku
Tel	022-252-1111
Email	yoshihk44@yahoo.co.jp

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	2020 Year 05 Month 08 Day

Related information
URL releasing protocol	Here
Publication of results	Unpublished

Result
URL related to results and publications	Here
Number of participants that the trial has enrolled	2305
Results	Of 2305 eligible participants, no severe adverse effects nor accidents were reported. Eighty-six percent of the participants replied to hope to receive similar sedation in future endoscopy.
Results date posted	2020 Year 05 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	mean age, 64 year male, 1215
Participant flow	Among 17989 endoscopy examinations during the study period, 4122 examinees underwent propofol administration. Of 3166 eligible people, 2305 participated in the study.
Adverse events	mild SpO2 decrease in 2.6% and mile HR decrease in 0.09%
Outcome measures	No severe adverse effects were observed
Plan to share IPD	None
IPD sharing Plan description	None

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 05 Day
Date of IRB	2016 Year 10 Month 21 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry	2018 Year 05 Month 01 Day
Date trial data considered complete	2020 Year 01 Month 31 Day
Date analysis concluded	2020 Year 05 Month 08 Day

Other
Other related information	Observation was conducted using a questionnaire survey

Management information
Registered date	2020 Year 05 Month 08 Day
Last modified on	2020 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046018

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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