UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on the effects of various single nucleotide polymorphisms on the analgesic and adverse effects of opioids
Title of the study (Brief title)	Genomic polymorphisms and effects of opioids
Region	Japan

Condition
Condition	intraoperative and postoperative pain in patients undergoing colectomy
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate relationships between genomic polymorphisms and analgesic as well as adverse effects of opioids in patients undergoing laparoscopic colectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	analgesic effects of fentanyl eveluated by pain test, amount of remifentanil required intraoperatively, amount of fentanyl required posoperatively, postoperative pain scale, adverse effects of fentanyl, genome-wide analysis of genomic polymorphisms
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	evaluation of analgesic effects of fentanyl using electricity-induced pain test
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	patients undergoing laparoscopic colectomy
Key exclusion criteria	patients with serious co-existing disease, patients taking tranquilizers or analgesics
Target sample size	300

Research contact person
Name of lead principal investigator	Hayashida, Masakazu
Organization	Saitama Medical University International Medical Center
Division name	Department of Anesthesiology
Address	1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
TEL	042-984-4394
Email	mhaya@juntendo.ac.jp

Public contact
Name of contact person	Hayashida, Masakazu
Organization	Saitama Medical University International Medical Center
Division name	Department of Anesthesiology
Address	1397-1 Yamane, Hidaka-shi, Saitama, Japan
TEL	042-984-4394
Homepage URL
Email	hayashi4@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization	Other
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	埼玉医科大学国際医療センター

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 23 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2015 Year 06 Month 01 Day
Date of closure to data entry	2015 Year 06 Month 01 Day
Date trial data considered complete	2015 Year 06 Month 01 Day
Date analysis concluded	2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.juntendo.ac.jp/graduate/kenkyudb/search/achievement.php?MID=4664
Results	We have identified multiple single nucleotide polymorhisms that can srtrongly affect postoperative fentanyl requirements by performing genome-wide association study in 350 patients who underwent laparoscopic colectomy.
Other related information

Management information
Registered date	2010 Year 06 Month 23 Day
Last modified on	2016 Year 12 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004361