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Completed

NCT Number: NCT00824772

Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Inje University Sanggye Paik Hospital

Seoul, 139-707, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative Cumulative Fentanyl Consumption

    Time frame: 24 hr after surgery

Secondary outcomes

  1. Postoperative Cumulative Fentanyl Consumption

    Time frame: 48hr after surgery

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Jan 19, 2009
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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