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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009142
Receipt No. 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

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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
Email 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
Email hk14@mitsuwakai.jp

Sponsor
Institute Tokyo east hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010717

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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