UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022903 |
|---|---|
| Receipt number | R000026392 |
| Scientific Title | Discovery of genetic variations associated with postoperative nausea and vomiting in Integrative Japanese Genome Variation Database |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2017/12/27 19:15:38 |
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Basic information
Public title
Discovery of genetic variations associated with postoperative nausea and vomiting
in Integrative Japanese Genome Variation Database
Acronym
Discovery of genetic variations associated with postoperative nausea and vomiting
in Integrative Japanese Genome Variation Database
Scientific Title
Discovery of genetic variations associated with postoperative nausea and vomiting
in Integrative Japanese Genome Variation Database
Scientific Title:Acronym
Discovery of genetic variations associated with postoperative nausea and vomiting
in Integrative Japanese Genome Variation Database
Region
| Japan |
Condition
Condition
Postoperative Nauseaa and Vomiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The goal of this study is to identify novel SNPs associated with incidence and severity of postoperative nausea and vomiting
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence aand severity of postoperative nausea and vomiting at 72hrs after surgery
Key secondary outcomes
Pain intensity, analgesic consumption, and complications at 72hrs after surgery
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
Surgical patients terated by opioids for postoperative pain
Key exclusion criteria
Patients with a history of previous PONV, liver deficiency, renal deficiency, dementia, psychiatric diseases, or chronic pain and those who were pregnant
Target sample size
261
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Sugino |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
shigekazu.sugino.d3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigekazu Sugino |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
Homepage URL
shigekazu.sugino.d3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine,
Department of Anesthesiology and Perioperative Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
小樽市立病院(北海道)，東北大学病院(宮城県)，東北メディカル・メガバンク機構(宮城県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 27 | 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
We found association of the MIR4300HG gene polymorphism with the incidence of postoperative nausea and vomiting.
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 | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Main results were showed at annual meeting of American Society of Anesthesiologists, Oct 21th - 25th, Boston, USA.
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026392
| 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 |
