UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040330 |
|---|---|
| Receipt number | 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 09:43:40 |
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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
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
yoshi-hk@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046018
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
