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

May 23, 2025 updated by: Kevin Harrod, University of Alabama at Birmingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This would be a prospective study for which patients not prescribed chronic pain medication (defined as not using narcotic medications in 3 months prior to surgery) and presenting for surgery would be recruited. Preop administration of sedating medications (i.e. midazolam) would be avoided. On the day of surgery, once in OR and standard ASA monitors placed, a standardized dose of 2mcg/kg ideal body weight IV fentanyl is administered. The patient is then monitored for respiratory depression for 5 minutes prior to administration of additional induction agents. [would include respiratory rate, with RR < 10, or O2 Sat < 90%]. Would not provide supplemental oxygen during this time unless patient was already on supplemental oxygen. Patient would then be preoxygenated and general anesthesia induced. Once general anesthesia is induced, a blood sample is collected and stored. [sample could also be collected in preop upon IV placement]. Blood will be tested for Single Nucleotide Polymorphisms of genes related to opioid-induced analgesia. [Potential target genes listed in 7.0-1] This genomic data will be evaluated for any correlations of the presence of opioid-related SNPs and concomitant opioid-induced respiratory depression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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.

Other Names:
  • Durogesic
  • Denpax
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

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.

Other Names:
  • Durogesic
  • Denpax

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Single Nucleotide Polymorphisms
Time Frame: 5 min Preop
Preop-Blood will be tested for Single Nucleotide Polymorphisms of genes related to opioid-induced analgesia
5 min Preop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tim Ness, MD, PhD, UAB Anesthesiology and Perioperative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F23456789
  • UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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