Respiratory DepressionNCT04495452
Precision Medicine in Anesthesia
An observational study of Respiratory Depression, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- Fentanyl Drug Administration
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will involve adult human volunteers, representative of the greater Alabama population.
Who may be able to join
- Healthy Subjects
- older than 19
- able to follow the study instructions
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Depression
- Being tested
- Fentanyl Drug Administration
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Drug AdministrationDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl Drug Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
A decrease in breathing frequency as quantified by respiratory rate
Measured: 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
Measured: 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
Measured: From the time of administration of study medication to 10 minutes after study medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start10 Jun 2024 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alethia Sellers, University of Alabama at Birmingham
- Investigators
- Alethia Sellers, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495452
- Sponsor's protocol ID
- IRB-300004738
- Status last verified
- Feb 2025
- First submitted
- 27 Apr 2020
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine in Anesthesia: Genetic Component in Opioid-induced Respiratory Depression
- ClinicalTrials.gov ID
- NCT04495452
- Acronym / sponsor ID
- IRB-300004738
- Conditions
- Respiratory Depression
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Drug: Fentanyl Drug AdministrationWe 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will involve adult human volunteers, representative of the greater Alabama population.
Key inclusion criteria (3 listed)
- Healthy Subjects
- older than 19
- able to follow the study instructions
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Drug AdministrationSubjects 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). | Drug | Study Participants |
Primary outcome
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alethia Sellers, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Depression, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (time frame: From the time of administration of study medication to 10 minutes after study medication administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.