Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing

Withdrawn before enrolling · Not applicable

Conditions studied: Perioperative/Postoperative Complications

In brief

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.

Key facts

Study ID

NCT03531268

Run by

Brigham and Women's Hospital

People needed

0

Starts

2018-10-20

Expected to finish

2020-05-20

Last updated by the study team

2019-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years of age or older at screening.
• Adults with qualifying insurance coverage.
• Subjects scheduled to undergo elective surgery with an expected hospitalization 24 hrs =/- 4 hrs after surgery.
• American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
• One or more of the following:
• Subjects prescribed 4 or more medications at time of surgery.
• Any subject prescribed any one of the following medication categories: opioid, benzodiazepine, antidepressant, antipsychotic, stimulant, mood stabilizer, NSAIDs, anti-epileptic drugs.
• Any subject prescribed any one of the following medication categories: antiplatelet therapy, anticoagulant drugs.
• Able to provide informed consent, adhere to the study protocol, and complete all study assessments.

You may not qualify if…

• Subjects who do not have insurance coverage for PGx testing.
• Subjects who are expected to have surgery prior to the ability to obtain the results of the pharmacogenomic testing (generally it takes 4 days to obtain the results of testing).
• Subjects who are not being prescribed 4 or more medications, or who are not receiving any of the medication categories noted in the inclusion criteria.
• Planned multiple surgical procedures within the 30-day study follow up period.
• Clinically significant medical or psychiatric disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease that would cause the subject to be unable to comply with the study requirements.
• Administration of an investigational drug within 30 days prior to providing PGx testing, or planned administration of an investigational product during the subject's participation in this study

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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