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

NCT03441282 | Terminated DMC FDA Drug

• 2 other identifiers: F23456789UAB
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• Single Nucleotide Polymorphisms

  Preop-Blood will be tested for Single Nucleotide Polymorphisms of genes related to opioid-induced analgesia

  5 min Preop

Study Arms (2)

ASA Patients I

Age 18-80 years old, English-speaking, not on current Fentanyl/opioid therapy, no use of opioid medications in the 3 months prior to surgery, scheduled for elective surgery at UAB main. A normal healthy patient Healthy, non-smoking, no or minimal alcohol use

Drug: Fentanyl

ASA Patients III

Age 18-80 years old, English-speaking, not on current Fentanyl/opioid therapy, no use of opioid medications in the 3 months prior to surgery, scheduled for elective surgery at UAB main. A patient with severe systemic disease Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA \< 60 weeks, history (\>3 months) of MI, CVA, TIA, or CAD/stents.

Drug: Fentanyl

Interventions

Fentanyl DRUG

After the patient is attached to an ASA non-invasive monitor, a dose (2mcg/kg) of Fentanyl will be administered. Groups compared would include patients experiencing respiratory depression vs those not experiencing respiratory depression after fentanyl administration. Their samples would be evaluated for any differences in genetic make-up concerning selected, known sequences affecting opioid-induced analgesia.

Also known as: Denpax, Durogesic

ASA Patients I; ASA Patients III

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be selected from the OR schedule and recruit/consent patients in the preop clinic or preop holding area during preop evaluation.

You may qualify if:

• Age 18-80 years old,
• English-speaking,
• Not on current opioid therapy,
• ASA I-III,
• Scheduled for elective surgery at UAB main

You may not qualify if:

• Chronic opioid therapy \[Consistent use of opioid meds 3 months prior to surgery\]
• pregnancy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tim Ness, MD, PhD

  UAB Anesthesiology and Perioperative Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: October 30, 2018
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

US (1)