UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013739 |
|---|---|
| Receipt number | R000016038 |
| Scientific Title | Evaluation of the intravenous anesthesia using propofol plus dexmedetomidine in endoscopic submucosal dissection |
| Date of disclosure of the study information | 2014/05/09 |
| Last modified on | 2016/11/14 22:36:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the intravenous anesthesia using propofol plus dexmedetomidine in endoscopic submucosal dissection
Acronym
Evaluation of the intravenous anesthesia using propofol plus dexmedetomidine in endoscopic submucosal dissection
Scientific Title
Evaluation of the intravenous anesthesia using propofol plus dexmedetomidine in endoscopic submucosal dissection
Scientific Title:Acronym
Evaluation of the intravenous anesthesia using propofol plus dexmedetomidine in endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Superficial esophageal cancer or early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the effects in safety and ESD treatment results between propofol alone and propofol plus dexmedetomidine as the intravenous anesthesia in ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient's hemodynamics during ESD
Key secondary outcomes
ESD performances
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Propofol plus dexmedetomidine
Interventions/Control_2
Propofol alone
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
The superficial esophageal cancer and early gastric cancer which plan to be resected by endoscopic submucosal dissection.
Key exclusion criteria
Patients with serious cardiovascular or pulmonary disease, renal dysfunction and liver dysfunction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2640
nonaka@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2640
Homepage URL
nonaka@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016038
