Precision Medicine in Anesthesia

NCT04495452 | Withdrawn FDA Drug

• 1 other identifier: IRB-300004738
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (3)

• Respiratory rate

  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

  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

  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

Study Arms (1)

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

Interventions

Fentanyl Drug Administration DRUG

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).

Study Participants

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample (about 10 mL) will be collected either during the IV line insertion or after fentanyl administration during the recovery period

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Alethia Sellers, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: July 31, 2020
• Study Start: June 10, 2024
• Primary Completion: December 10, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share