Respiratory Depression Clinical Trial
Official title:
Precision Medicine in Anesthesia: Genetic Component in Opioid-induced Respiratory Depression
Verified date | December 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2025 |
Est. primary completion date | December 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Alabama at Birmingham |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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