UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021487 |
|---|---|
| Receipt number | R000024784 |
| Scientific Title | A prospective comparative study of the sedation between a combination of propofol and dexmedetomidine hydrochloride and propofol alone in esophageal endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2016/03/20 |
| Last modified on | 2021/12/03 20:20:28 |
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Basic information
Public title
A prospective comparative study of the sedation between a combination of propofol and dexmedetomidine hydrochloride and propofol alone in esophageal endoscopic submucosal dissection.
Acronym
Evaluation of the sedation with a combination of PF and DEX during esophageal ESD.
Scientific Title
A prospective comparative study of the sedation between a combination of propofol and dexmedetomidine hydrochloride and propofol alone in esophageal endoscopic submucosal dissection.
Scientific Title:Acronym
Evaluation of the sedation with a combination of PF and DEX during esophageal ESD.
Region
| Japan |
Condition
Condition
Superficial esophageal carcinomas or intraepithelial neoplasias scheduled for ESD.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of sedation with a combination of propofol (PF) and dexmedetomidine hydrochloride (DEX) compared with sedation with PF alone during esophageal endoscopic submucosal dissection (ESD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence of excess body movement during ESD.
Key secondary outcomes
ESD outcomes (including en bloc resection rate, complete resection rate and procedure times).
The occurrence of procedure-related and sedation-related complication.
The degree of satisfaction for ESD among physicians and assistants using a visual analog scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The sedation with a combination of propofol and dexmedetomidine hydrochloride.
Interventions/Control_2
The sedation with 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
Patients with superficial esophageal carcinomas and intraepithelial neoplasias scheduled for ESD.
Key exclusion criteria
Patients classified with an ASA physical status higher than II.
Patients with a tracheotomy.
Patients with any airway disorder.
Patients with a cardiac pacemaker.
Patients with gastric tube after esophageal surgery.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2640
nonaka_taka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University School of Medicine
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_taka@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine
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
| 2016 | Year | 03 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2016 | Year | 03 | Month | 16 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024784
