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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023295
Receipt No. 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

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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
Email 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
Email kameda@nms.ac.jp

Sponsor
Institute Nippon Medical School Musashikosugi Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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