UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010267 |
|---|---|
| Receipt number | R000012016 |
| Scientific Title | Investigations of relation between multiple gene polymorphisms, modifications, and postoperative nausea and vomiting. |
| Date of disclosure of the study information | 2013/03/19 |
| Last modified on | 2015/03/31 09:06:53 |
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Basic information
Public title
Investigations of relation between multiple gene polymorphisms, modifications, and postoperative nausea and vomiting.
Acronym
PONV related gene polymorphisms and modifications
Scientific Title
Investigations of relation between multiple gene polymorphisms, modifications, and postoperative nausea and vomiting.
Scientific Title:Acronym
PONV related gene polymorphisms and modifications
Region
| Japan |
Condition
Condition
Patients who are scheduled to undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
PONV is a frequent and debilitating complication after general anesthesia. However, the mechanisms of PONV are not fully elucidated. It has been reported that some gene polymorphisms were related to the chemotherapy induced nausea and vomiting (CINV). We focused on the TACR1, 5HT3, DRD2, and oprm1 gene that were related to CINV or PONV.
Basic objectives2
Others
Basic objectives -Others
The aim of the present study was to determine whether the gene polymorphism (single nucleotide polymorphisms) and the gene modification (gene methylation) were related to the occurence or incidence of PONV.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of postoperative nausea and vomiting.
Key secondary outcomes
Intensity of postoperative nausea and vomiting.
Dose of antiemetics drug.
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
The patients who are scheduled to undergo general anesthesia are enrolled in this study.
Key exclusion criteria
cardiovascular disease
pulmonary disease
neuropsychiatric disease
anticoagulant therapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Sugino |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
West 16, South 1, Chuo-ku, Sapporo
TEL
0116112111
hayash@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomo Hayase |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
West 16, South 1, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
eric.core2006@gmail.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Institutional 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
Address
Tel
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
| 2013 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients who are scheduled to undergo general anesthesia (ASA-PS 1-2, age 20-85) are enrolled in this study.
The genomic DNA is extracted from 2mL of blood.
The occurrence and duration of PONV were recorded 24 h after surgery.
Management information
Registered date
| 2013 | Year | 03 | Month | 18 | Day |
Last modified on
| 2015 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012016
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