UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association of genetic variation of the OPRM1 gene with perioperative opioid analgesia
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shigekazu Sugino
Organization	1) Otaru General Hospital 2) Tohoku University
Division name	Anesthesia
Address	1-1, Wakamatsu 1, Otaru, Hokkaido 047-8550, JAPAN
TEL	0134251211
Email	sugino@ruby.ocn.ne.jp

Public contact
Name of contact person	Yukihiro Kumeta
Organization	Otaru General Hospital
Division name	Anesthesia
Address	1-1, Wakamatsu 1, Otaru, Hokkaido 047-8550, JAPAN
TEL	0134251211
Homepage URL
Email	kumeta-yu@otaru-general-hospital.jp

Sponsor
Institute	Otaru General Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 08 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026389