WithdrawnNot Applicable

Precision Medicine in Anesthesia

Stopped: Study initially halted due to the COVID pandemic because the research ventilator was repurposed for life saving efforts. Due to later clinical demands, the study was able to be restarted.

0Started 2024-06-10

Plain-language 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.

Who can participate

Age range

19 Years – 40 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: * 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

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

Respiratory rate

Timeframe: From the time of administration of study medication to 10 minutes after study medication administration

Minute Ventilation

Timeframe: From the time of administration of study medication to 10 minutes after study medication administration

Occlusion Pressure

Timeframe: From the time of administration of study medication to 10 minutes after study medication administration

Trial details

NCT IDNCT04495452

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-10

View on ClinicalTrials.gov More Respiratory Depression trials

Plain-language summary

Who can participate

Age range

19 Years – 40 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.

What they're measuring

Respiratory rate

Timeframe: From the time of administration of study medication to 10 minutes after study medication administration

Minute Ventilation

Timeframe: From the time of administration of study medication to 10 minutes after study medication administration

Occlusion Pressure

Timeframe: From the time of administration of study medication to 10 minutes after study medication administration