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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023785
Receipt No. R000027402
Scientific Title Low dose fentanyl could predict postoperative nausea and vomitting in association with gene polymorphisms of opioid receptors or transportors
Date of disclosure of the study information 2016/09/01
Last modified on 2018/08/24

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Basic information
Public title Low dose fentanyl could predict postoperative nausea and vomitting in association with gene polymorphisms of opioid receptors or transportors
Acronym Low dose fentanyl could predict PONV in association with SNPs of OPRM1
Scientific Title Low dose fentanyl could predict postoperative nausea and vomitting in association with gene polymorphisms of opioid receptors or transportors
Scientific Title:Acronym Low dose fentanyl could predict PONV in association with SNPs of OPRM1
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To improve the prediction accuracy of PONV.
To clarify the association of PONV and gene polymorphism of opioid receptors or transporters.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative nausea and vomitting
SNPs related to Opoioids
Key secondary outcomes Use of antiemetics
Intensity of postoperative pain
Use of analgesics

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who undergo laparoscopic colectomy/rectal resection under epidural and general anesthesia
Key exclusion criteria ASA3/4
Re-operation within 4POD
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoko Sugiyama
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu city, Gifu
TEL 81-58-230-6404
Email yoko_sg@gifu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yoko Sugiyama
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu city, Gifu
TEL 81-58-230-6404
Homepage URL
Email yoko_sg@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization Gifu University Graduate School of Medicin
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
Email

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 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2015 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Demographic data
Any symptom after administration of low dose fentanyl
Incidence of PONV
Intensity of ostoperative pain
Use of antiemetics or analgesics
Blood concentration of fentanyl on 1POD
SNPs of opioid receptors or transporters

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027402

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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