Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

May 26, 2013 updated by: Kye-Min Kim, Inje University

Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5

Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.

Study Overview

Status

Completed

Conditions

Detailed Description

The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.

Study Type

Observational

Enrollment (Actual)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 139-707
        • Inje University Sanggye Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Gynecologic patients undergoing total abdominal hysterectomy or laparoscpy assisted vaginal hysterectomy under general anesthesia

Description

Inclusion Criteria:

  • Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal hysterectomy (LAVH) under general anesthesia
  • Patients who want to use intravenous patient controlled analgesia (PCA) after surgery
  • ASA physical status class I, II

Exclusion Criteria:

  • history of drug addiction
  • opioid medication within 12 hours before surgery
  • previous history of opioid medication for 3 months
  • neurologic disorder
  • cardiac disorder
  • hepatic disease
  • renal disease
  • respiratory disease such as COPD, asthma
  • sleep apnea
  • BMI > 30
  • psycotic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative Cumulative Fentanyl Consumption
Time Frame: 24 hr after surgery
24 hr after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative Cumulative Fentanyl Consumption
Time Frame: 48hr after surgery
48hr after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Kye-Min Kim, MD. PhD., Department of Anesthesia, Inje University Sanggye Paik Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

May 26, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00012007317-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe