TerminatedNot Applicable

Precision Medicine in Anesthesia: Genetic Component in Opioid-induced Respiratory Depression

Stopped: Investigator decision

United States26 participantsStarted 2018-10-30

Plain-language summary

The concept of precision medicine - taking individual variability into account when planning preventions and interventions - is not new but is quickly gaining attention in this age of powerful methodology of patient characterization and development of tools to analyze large sets of data. Oncology is the most obvious field in which this information has been readily applied. Increasing focus, nationally and internationally, on developing broad databases of patient genetic information and research efforts evaluating those data will, hopefully, lead to the development and application of evidence-based data enhancing the practice of all fields of medicine. It has yet to become obvious how this information can best be applied to the field of anesthesiology. Most genomics work in anesthesia has been focused in the area of pain medicine. There is a known genetic influence on the potency of opioid-induced analgesia, however; a genetic component of opioid-induced respiratory depression has yet to be thoroughly evaluated. Respiratory depression plays a role in clinical care - from procedures requiring sedation with monitored anesthesia care to treating post-opertative pain and chronic pain - but perhaps its largest current role in the public arena is the unfortunate deaths caused by side effects due to drug overdose. Personalized medicine remains on the horizon for the field of anesthesia, but, as genetic testing becomes more affordable and mainstream in clinical practice, the potential applications are broad. Most readily would be its incorporation into development of patient specific pain regimens. Respiratory depression is a potentially lethal side effect of opioid therapy. In light of the opioid epidemic and CDC-scrutiny of opioid use, determining genetic profiles susceptible to respiratory depression could prove useful in further tailoring the treatment of pain both in the perioperative setting and in the chronic pain management setting.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-80 years old, * English-speaking, * Not on current opioid therapy, * ASA I-III, * Scheduled for elective surgery at UAB main Exclusion Criteria: * Chronic opioid therapy \[Consistent use of opioid meds 3 months prior to surgery\] * pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Single Nucleotide Polymorphisms

Timeframe: 5 min Preop

Trial details

NCT IDNCT03441282

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-21

View on ClinicalTrials.gov More Respiratory Depression trials