UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009980 |
|---|---|
| Receipt number | R000011690 |
| Scientific Title | Safety and efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia. |
| Date of disclosure of the study information | 2013/02/06 |
| Last modified on | 2022/04/20 15:53:42 |
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Basic information
Public title
Safety and efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Acronym
Safety efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Scientific Title
Safety and efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Scientific Title:Acronym
Safety efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Region
| Japan |
Condition
Condition
cervical esophageal cancer
pharyngeal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of dexmedetomidine between high dose and low dose for postoperative sedation, after endoscopic submucosal dissection under general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
respiration, hemodynamic, complication, RASS score, VRS, the number of sedatives and analgesics, the number of fentanyl IV-PCA, questionnair
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Hight dose of dexmedetomidine
Interventions/Control_2
Low dose of dexmedetomidine
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
To undergo ESD under general anesthesia.
To keep inubated until the next morning in the intensive care unit.
Consenting patients
Key exclusion criteria
ASA class >3.
BMI <35.
Routine oral administration of sedatives and analgesics.
Drug allergy of dexmedetomidine
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Yamaguchi |
Organization
Juntendo university
Division name
anesthesiology
Zip code
Address
Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chika Ishibashi |
Organization
Juntendo university
Division name
Anesthesiology
Zip code
Address
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Funding Source
Organization
non
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2015 | 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
| 2013 | Year | 02 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011690
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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