UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015785 |
|---|---|
| Receipt number | R000018370 |
| Scientific Title | The observational study on the safety of dexmedetomidine during double-balloon endoscope |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2016/05/30 15:45:12 |
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Basic information
Public title
The observational study on the safety of dexmedetomidine during double-balloon endoscope
Acronym
The observational study on the safety of dexmedetomidine during double-balloon endoscope
Scientific Title
The observational study on the safety of dexmedetomidine during double-balloon endoscope
Scientific Title:Acronym
The observational study on the safety of dexmedetomidine during double-balloon endoscope
Region
| Japan |
Condition
Condition
small intestine disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety of using dexmedetomidine as the intravenous anesthesia in double-balloon endoscopy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body movement during double-balloon endoscopy
Key secondary outcomes
Circulation and Respiration during double-balloon endoscopy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will be performed small-bowel enteroscopy with suspected or known small bowel diseases
Key exclusion criteria
Pregnant patients
Patients with poor general condition
Patients with serious cardiovascular or pulmonary disease, renal dysfunction and liver dysfunction.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Goto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2172
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Oshima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
h-oshima@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 04 | Month | 01 | Day |
Other
Other related information
Evaluation of circulation, Respiration, drug usage and sedation depth, procedural accidents, and so on
Management information
Registered date
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2016 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018370
