UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047809 |
|---|---|
| Receipt number | R000054501 |
| Scientific Title | Use experience of opioid antagonists peripheral for endotracheal intubation patients |
| Date of disclosure of the study information | 2022/05/19 |
| Last modified on | 2023/05/21 13:40:15 |
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Basic information
Public title
Use experience of opioid antagonists peripheral for endotracheal intubation patients
Acronym
Use experience of opioid antagonists peripheral for endotracheal intubation patients
Scientific Title
Use experience of opioid antagonists peripheral for endotracheal intubation patients
Scientific Title:Acronym
Use experience of opioid antagonists peripheral for endotracheal intubation patients
Region
| Japan |
Condition
Condition
intubation patients
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The patients had endotracheal intubation of are given opioid antagonists
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to movement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nardemedine Mesylate Hydrochloride
0.2mg
4days
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It is made an endotracheal intubation more than 72 hours
A narcotic analgesic is used
There is not a movement for three days
Key exclusion criteria
A gastrointestinal ulceration, diverticular disorders, an invasive digestion duct carcinoma, the disease with the risk of the gastrointestinal perforation including peritoneal metastases, the Crohn disease of cancer.
Under 18 years old
There is a movement within 72 hours
Extubation within the 72:00 time, ICU discharge, discharge
The patients with the diarrhea
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | ryo |
| Middle name | |
| Last name | ichibayashi |
Organization
Toho University Medical Center, Omori Hospital
Division name
Department of Critical Care Center
Zip code
1438541
Address
6-11-1 Omori- Nishi, Ota-ku, Tokyo 143-8541, Japan.
TEL
+81337624151
ryou.ichibayashi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | ryo |
| Middle name | |
| Last name | ichibayashi |
Organization
Toho University Medical Center Omori Hospital
Division name
Department of Critical Care Center
Zip code
1438541
Address
6-11-1 Omori- Nishi, Ota-ku, Tokyo 143-8541, Japan.
TEL
+81337624151
Homepage URL
ryou.ichibayashi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Medical Center Omori Hospital
Institute
Department
Personal name
Funding Source
Organization
Toho University Medical Center Omori Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Medical Center Omori Hospital
Address
Department of Critical Care Center
Tel
+81337624151
ryou.ichibayashi@med.toho-u.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
| 2022 | Year | 05 | Month | 19 | 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
50
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
| 2020 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 31 | 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
| 2022 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054501
