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Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00824772
First received: January 16, 2009
Last updated: December 7, 2010
Last verified: January 2009
History of Changes
  Purpose

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.


Condition
Pain, Postoperative

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • fentanyl cumulative dose (given by patient-controlled analgesia device) [ Time Frame: 1, 2, 6, 24, 48hr after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • requirement of rescue analgesics [ Time Frame: 48hr after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Patients undergoing total abdominal hysterectomy or laparoscopy assisted vaginal hysterectomy under general anesthesia
  • Patients who want to use intravenous patient controlled analgesia 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824772

Locations
Korea, Republic of
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of, 139-707
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Kye-Min Kim, MD. PhD. Department of Anesthesia, Inje University Sanggye Paik Hospital
  More Information

No publications provided

Responsible Party: Kye-Min Kim/ Assistant professor of department of Anesthesia and Pain Medicine, Inje University Sanggye Paik Hospital,
ClinicalTrials.gov Identifier: NCT00824772     History of Changes
Other Study ID Numbers: 00012007317-00
Study First Received: January 16, 2009
Last Updated: December 7, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Inje University:
pharmacogenetics

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 22, 2013