UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022900 |
|---|---|
| Receipt number | R000026389 |
| Scientific Title | Association of genetic variation of the OPRM1 gene with perioperative opioid analgesia |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2016/06/27 12:33:30 |
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Basic information
Public title
Association of genetic variation of the OPRM1 gene with perioperative opioid analgesia
Acronym
Association of genetic variation of the OPRM1 gene with perioperative opioid analgesia
Scientific Title
Association of genetic variation of the OPRM1 gene with perioperative opioid analgesia
Scientific Title:Acronym
Association of genetic variation of the OPRM1 gene with perioperative opioid analgesia
Region
| Japan |
Condition
Condition
Postoperative Nausea and Vomiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The goal of the present study was to determine, in a cohort of Japanese surgical patients, genetic and epigenetic variations of several SNPs in the OPRM1 gene, and their association with PONV during the postoperative period.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
severity of postoperative nausea and vomiting at 72hrs after surgery
Key secondary outcomes
pain intensity at 72hrs after surgery, analgesics consumption at 72hrs after surgery, 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
Elective surgical patients with ASA-physical staus of 1 or 2
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
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Sugino |
Organization
1) Otaru General Hospital
2) Tohoku University
Division name
Anesthesia
Zip code
Address
1-1, Wakamatsu 1, Otaru, Hokkaido 047-8550, JAPAN
TEL
0134251211
sugino@ruby.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Kumeta |
Organization
Otaru General Hospital
Division name
Anesthesia
Zip code
Address
1-1, Wakamatsu 1, Otaru, Hokkaido 047-8550, JAPAN
TEL
0134251211
Homepage URL
kumeta-yu@otaru-general-hospital.jp
Sponsor or person
Institute
Otaru General Hospital
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(麻酔科)
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
Sugino S, Hayase T, Higuchi M, Saito K, Moriya H, Kumeta Y, Kurosawa N, Namiki A, Janicki PK: Associations of Mu-opioid receptor gene (OPRM1) gene haplotypes with postoperative nausea and vomiting (PONV) during intravenous patient-controlled analgesia. Exp Brain Res 2014;232:2627-35.
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
| 2008 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
We found a novel intronic SNP of the OPRM1 gene (rs9397685) that was associated with differences in the incidence and severity of PONV in the Japanese surgical population. The GGGAACGC haplotype constructed from eight SNPs, including A118G and the novel intronic SNP, in the OPRM1 gene, was associated with decreased severity of PONV.
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026389
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