UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023785 |
|---|---|
| Receipt number | 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 | 2019/08/30 12:22:17 |
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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
Name of lead principal investigator
| 1st name | YOKO |
| Middle name | |
| Last name | Sugiyama |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu city, Gifu
TEL
81-58-230-6404
yoko_sg@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Sugiyama |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu city, Gifu
TEL
81-58-230-6404
Homepage URL
yoko_sg@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
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
Gifu University Graduate School of Medicine IRB
Address
1-1 Yanagido Gifu city, Gifu
Tel
81-58-230-6059
gjme0005@jim.gifu-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
| 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
105
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
| 2015 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
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
| 2019 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027402
| 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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| Registered date | File name |
