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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040330
Receipt No. R000046018
Scientific Title Prospective evaluation for Propofol sedation in screening endoscopy
Date of disclosure of the study information 2020/05/08
Last modified on 2020/05/08

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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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