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NCT00824772 Clinical Trial

Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00824772
Other study ID # 00012007317-00
Secondary ID
Status Completed
Phase N/A
First received January 16, 2009
Last updated May 26, 2013
Start date September 2008
Est. completion date December 2012

Study information
Verified date May 2013
Source Inje University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date December 2012
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 65 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Inje University Sanggye Paik Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Cumulative Fentanyl Consumption 24 hr after surgery No
Secondary Postoperative Cumulative Fentanyl Consumption 48hr after surgery No
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