Precision Medicine in Anesthesia

February 3, 2025 updated by: Alethia Sellers, University of Alabama at Birmingham

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

This study is designed to look at how often a decrease in the rate of breathing occurs after being given a routinely used intravenous (IV) pain medication. This pain medication (Fentanyl) is given in the research procedure room by the anesthesiologist. In addition to relieving pain, in some patients it has been observed that this medication may decrease the rate of breathing.

Different pieces of one's genetic makeup (also known as genes) can affect how well this medication relieves pain. The investigators do not know if these same genes influence how large the effect of the medication has on breathing rate. The purpose of this study is to determine if the presence or alteration of these same genes may be associated with a decrease in rate of breathing.

Study Overview

Status

Status

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Withdrawn

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

Opioids are key analgesic drugs. Unfortunately, they have a high potential for abuse with potentially lethal consequences, more specifically death due to respiratory suppression. In both Canada and the US, the number of deaths from opioid overdose continues to rise at an alarming rate, far exceeding fatalities from motor vehicle accidents in Canada and becoming the number one cause of unintentional injury-related death in the US. 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.

The purpose of the proposed study is to evaluate for a genetic component of opioid-induced respiratory depression. Our overall study hypothesis is that genetic variation influences opioid-induced respiratory depression.

The primary aim of the study is to correlate an intravenous opioid bolus and genetic variations of opioid-related target genes. Secondary aims or outcomes are the determination of general variation in respiratory responses in response to a single intravenous fentanyl bolus. Other observed effects are age and gender related differences, the effect of a single fentanyl bolus on alertness, the incidence of emesis and opioid effects on micturition as determined by the modified Aldrete discharge criteria.

Based on existing work on genetic determinants of opioid receptor effects, we propose to correlate clinical parameters of respiratory depression (proportional reduction in respiratory minute ventilation) with the expression of single-nucleotide polymorphisms (SNPs) of genes related to opioid-induced analgesia. We propose to identify a subset of participants with the most significant respiratory depression and contrast those with participants that exhibit no respiratory effects. The blood samples from these two groups will be used to compare genetic variances of genes related to opioid-induced analgesia.

This will be a collaborative project between the clinical physicians and basic scientists in an effort to better characterize opioid-induced respiratory depression. We believe this work will be valuable as a means to prevent and treat opioid toxicity and guide development of safer approaches to opioid therapy and drug development.

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

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ayesha Bryant, MD, MSPH
  • Phone Number: 205-934-4969

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

19 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will involve adult human volunteers, representative of the greater Alabama population.

Description

Inclusion Criteria:

  • Healthy Subjects
  • older than 19
  • able to follow the study instructions

Exclusion Criteria:

  • Any medical condition that could affect study procedures or potentially put the subject at risk, in the opinion of the investigators
  • age less than 18 or older than 40
  • pregnancy
  • obesity
  • sleep apnea
  • pulmonary problems such as moderate or severe bronchial asthma
  • epilepsy
  • chronic analgesic medication
  • history of surgery for which details are unavailable
  • allergy to fentanyl
  • history of drug abuse
  • positive urine test for illicit drugs
  • female participants will be scheduled for a urine pregnancy test on the day of the procedure, prior to receiving study medication, only subjects with negative tests will continue

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.
Study Participants

We will be enrolling 200 participants, this will provide a large enough sampling to assure there are at least 25 patients with significant respiratory depression and 25 with insignificant respiratory depression.

The genetic data from participants with the most respiratory depression defined as having a 20-40% decrease from initial respiratory parameters will be compared with genetic data from participants with the least respiratory depression defined as having no change or less than 10% decrease from initial respiratory parameters.
Drug: Fentanyl Drug Administration
Subjects will be given a standardized dose of fentanyl 2.5 mcg/kg estimated ideal body weight (males: ideal body weight = 50 kg + 2.3 kg for each inch over 5 feet. Females: Ideal body weight = 45.5 kg + 2.3 kg for each inch over 5 feet).

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
Respiratory rate
Time Frame: From the time of administration of study medication to 10 minutes after study medication administration
A decrease in breathing frequency as quantified by respiratory rate
From the time of administration of study medication to 10 minutes after study medication administration
Minute Ventilation
Time Frame: From the time of administration of study medication to 10 minutes after study medication administration
A decrease in breathing as quantified by minute ventilation
From the time of administration of study medication to 10 minutes after study medication administration
Occlusion Pressure
Time Frame: From the time of administration of study medication to 10 minutes after study medication administration
A measure of respiratory depression as quantified by occlusion pressure
From the time of administration of study medication to 10 minutes after study medication administration

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.
  • Principal Investigator: Alethia Sellers, MD, University of Alabama at Birmingham

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 (Estimated)

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.
June 10, 2024

Primary Completion (Estimated)

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.
December 10, 2025

Study Completion (Estimated)

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.
September 1, 2026

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).
April 27, 2020

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.
July 30, 2020

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.
July 31, 2020

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.
March 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.
February 3, 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.
February 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.
  • IRB-300004738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Respiratory Depression

Clinical Trials on Fentanyl Drug Administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings