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Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing

NCT03531268 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-01-17

No results posted yet for this study

Summary

In the perioperative realm, studies have demonstrated an association of genotype with efficacy of medications applicable to the surgical setting. A clinical association exists between the genotype of various genes and with opioid efficacy and toxicity - specifically for drugs such as oxycodone, codeine, morphine, fentanyl, and tramadol. More studies are needed to assess the effects of personalized dosing of analgesics during the perioperative process for various surgical procedures. The application of Pharmacogenomic testing (PGx) to perioperative medicine is novel, has much potential for growth and may potentially improve outcomes. However, successful implementation of a system to evaluate PGx and integrate results into clinical decision-making is challenging and has not been adequately assessed. The investigators propose to conduct PGx testing for patients undergoing surgery, evaluate its clinical utility, and assess outcomes. The investigators hypothesize that PGx testing may ultimately lead to a decrease in adverse events and improved outcomes in the perioperative period.

Conditions

  • Perioperative/Postoperative Complications

Interventions

OTHER

PGx Testing

Pharmacogenomic (PGx) testing will be administered to all subjects. The results of PGx testing will be evaluated for clinical utility. Subjects will be evaluated based on whether PGx testing has clinical utility or has no clinical utility.

Sponsors & Collaborators

  • CQuentia NGS, LLC

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Srdjan S Nedeljkovic, MD · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-20
Primary Completion
2020-05-20
Completion
2020-05-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531268 on ClinicalTrials.gov