Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

NCT ID: NCT00824772

Last Updated: 2013-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Kye-Min Kim

Associate professor, Department of Anesthesiolgy & Pain Medicine, Inje University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kye-Min Kim, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Inje University Sanggye Paik Hospital

Locations

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Inje University Sanggye Paik Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim KM, Kim HS, Lim SH, Cheong SH, Choi EJ, Kang H, Choi HR, Jeon JW, Yon JH, Oh M, Shin JG. Effects of genetic polymorphisms of OPRM1, ABCB1, CYP3A4/5 on postoperative fentanyl consumption in Korean gynecologic patients. Int J Clin Pharmacol Ther. 2013 May;51(5):383-92. doi: 10.5414/CP201824.

Reference Type DERIVED
PMID: 23557865 (View on PubMed)

Other Identifiers

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00012007317-00

Identifier Type: -

Identifier Source: org_study_id

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