UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023295 |
|---|---|
| Receipt number | R000026852 |
| Scientific Title | prevension of SSI by very low-dose naloxone |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2020/01/24 18:05:33 |
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Basic information
Public title
prevension of SSI by very low-dose naloxone
Acronym
naloxone and SSI
Scientific Title
prevension of SSI by very low-dose naloxone
Scientific Title:Acronym
naloxone and SSI
Region
| Japan |
Condition
Condition
colorectal surgery
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
very low-dose naloxone infusion may prevent the development of SSI after remifentanil based anesthesia in colorectal surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative SSI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Saline as control from the start of anesthesi to the end of surgery
Interventions/Control_2
Administration of very low-dose naloxone(0.25ug/kg/hr)under remifentanil based anesthesia from strat of anesthesia to the end of surgery
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
Colorectal cancer surgety in respective institusion
Key exclusion criteria
Reoperation
patients with ireus tube
emergency operation
patients who declined
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Manzo |
| Middle name | |
| Last name | Suzuki |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Anesthesiology
Zip code
211-8533
Address
1-396 kosugi-tyo Nakaharaku Kawasaki
TEL
044-733-5181
manzo@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kameda |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
syomuka
Zip code
211-8533
Address
1-396 kosugi-tyo Nakaharaku Kawasaki
TEL
044-733-5181
Homepage URL
kameda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Musashikosugi Hospital
Institute
Department
Personal name
Funding Source
Organization
Only Departmental Source
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
IRB committee Musashikosugi hospital nippon Medical school
Address
1-396 Kosugi-cho Nakaharaku Kawasaki
Tel
044-733-5181
kameda@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
日本医科大学武蔵小杉病院
日本医科大学多摩永山病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 30 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026852
