UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033997 |
|---|---|
| Receipt number | R000038767 |
| Scientific Title | Evaluation of side-effects of dexmedetomidine depending on the volume of infusion during endoscopic submucosal dissection |
| Date of disclosure of the study information | 2018/09/03 |
| Last modified on | 2021/09/28 16:39:50 |
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Basic information
Public title
Evaluation of side-effects of dexmedetomidine depending on the volume of infusion during endoscopic submucosal dissection
Acronym
Side-effects of dexmedetomidine depending on the volume of infusion during ESD
Scientific Title
Evaluation of side-effects of dexmedetomidine depending on the volume of infusion during endoscopic submucosal dissection
Scientific Title:Acronym
Side-effects of dexmedetomidine depending on the volume of infusion during ESD
Region
| Japan |
Condition
Condition
neoplastic lesions of esophagus, stomach and colon
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of 100ml or 1500ml infusion for preventing from the side-effects of dexmedetomidine during endoscopic submucosal dissection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Side-effects (hypotension, bradycardia, respiratory depression)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1500ml infusion
Interventions/Control_2
1000ml infusion
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who undergo ESD (esophagus, stomach and colon) with using DEX
Key exclusion criteria
1)uncontrollable diabetes
2)uncontrollable hypertension
3)uncontrollable heart disease
4)uncontrollable renal and/or urological diseases
5)hypovolemic
6)severe or uncontrollable respiratory disease
7)acute alcoholic addiction
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Akimoto |
Organization
Nippon Medical School Chiba-Hokuso Hospital
Division name
Department of Gastroenterology
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba, Japan
TEL
0476-99-1111
s03-004an@nms.ac.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Nishimoto |
Organization
Nippon Medical School Chiba-Hokuso Hospital
Division name
Department of Gastroenterology
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba, Japan
TEL
0476-99-1111
Homepage URL
clubman629@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
own fund
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
Nippon Medical School Chiba-Hokuso Hospital IRB
Address
1715 Kamagari, Inzai, Chiba, Japan
Tel
0476-99-1111
araraki@nms.ac.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
| 2018 | Year | 09 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038767
