UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009142 |
|---|---|
| Receipt number | R000010717 |
| Scientific Title | Safety and effectiveness of sedation during and after diagnostic esophagogastroduodenoscopy: randomiszed comparisons between propofol and midazolam. |
| Date of disclosure of the study information | 2012/10/18 |
| Last modified on | 2013/10/23 08:07:30 |
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Basic information
Public title
Safety and effectiveness of sedation during and after diagnostic esophagogastroduodenoscopy: randomiszed comparisons between propofol and midazolam.
Acronym
The comparisons between propofol and midazolam for diagnostic esophagogastroduodenoscopy sedation.
Scientific Title
Safety and effectiveness of sedation during and after diagnostic esophagogastroduodenoscopy: randomiszed comparisons between propofol and midazolam.
Scientific Title:Acronym
The comparisons between propofol and midazolam for diagnostic esophagogastroduodenoscopy sedation.
Region
| Japan |
Condition
Condition
Upper gastrointestinal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare safety and efficacy between propofol and midazolam during and after diagnostic esophaogogastroduodenoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety:
Vital signs, respiratory depression, full recovery (conscious level, motor function), the occurrence of adverse events within 24h after procedure
Effectiveness:
Overall satisfaction of procedures from patients' questionnaires
Key secondary outcomes
Successful procedure, depth of anesthesia, means of transfer after procedure and any other complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Propofol
Interventions/Control_2
Midazolam
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients and inpatients of Tokyo east hospital or clinic adjacent to the hospital (Kikuchi geka-ichoka clinic).
Key exclusion criteria
Assigned to American Society of Anesthesiologists classes III and IV, severe liver dysfunction, pregnant, paresis after cerebral infarction, overweight (body weight > 100kg), allergic to the drug used or its components (soybeans or eggs), emergency procedure
Others who could not accept this study concept or was estimated as inadequate for this study by the primary doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisae Yamamoto |
Organization
Tokyo east hospital
Division name
Internal medicine
Zip code
Address
3-20-3 Shishibone Edogawa-ku Tokyo, Japan
TEL
0356363030
hisaese@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Kikuchi |
Organization
Tokyo east hospital
Division name
Surgery
Zip code
Address
3-20-3 Shishibone Edogawa-ku Tokyo, Japan
TEL
0356363030
Homepage URL
hk14@mitsuwakai.jp
Sponsor or person
Institute
Tokyo east hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京東病院(Tokyo East Hospital)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 18 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 18 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 18 | Day |
Last modified on
| 2013 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010717
