Respiratory DepressionNCT03441282
Precision Medicine in Anesthesia: Genetic Component in Opioid-induced Respiratory Depression
An observational study of Respiratory Depression, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The concept of precision medicine - taking individual variability into account when planning preventions and interventions - is not new but is quickly gaining attention in this age of powerful methodology of patient characterization and development of tools to analyze large sets of data. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- Fentanyl
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 21 May 2025
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from the OR schedule and recruit/consent patients in the preop clinic or preop holding area during preop evaluation.
Who may be able to join
- Age 18-80 years old,
- English-speaking,
- Not on current opioid therapy,
- ASA I-III,
- Scheduled for elective surgery at UAB main
Who cannot join
- Chronic opioid therapy [Consistent use of opioid meds 3 months prior to surgery]
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
The concept of precision medicine - taking individual variability into account when planning preventions and interventions - is not new but is quickly gaining attention in this age of powerful methodology of patient characterization and development of tools to analyze large sets of data. Oncology is the most obvious field in which this information has been readily applied. Increasing focus, nationally and internationally, on developing broad databases of patient genetic information and research efforts evaluating those data will, hopefully, lead to the development and application of evidence-based data enhancing the practice of all fields of medicine. It has yet to become obvious how this information can best be applied to the field of anesthesiology. Most genomics work in anesthesia has been focused in the area of pain medicine. There is a known genetic influence on the potency of opioid-induced analgesia, however; a genetic component of opioid-induced respiratory depression has yet to be thoroughly evaluated. Respiratory depression plays a role in clinical care - from procedures requiring sedation with monitored anesthesia care to treating post-opertative pain and chronic pain - but perhaps its largest current role in the public arena is the unfortunate deaths caused by side effects due to drug overdose.
Personalized medicine remains on the horizon for the field of anesthesia, but, as genetic testing becomes more affordable and mainstream in clinical practice, the potential applications are broad. Most readily would be its incorporation into development of patient specific pain regimens. Respiratory depression is a potentially lethal side effect of opioid therapy. 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.
Read the detailed description
This would be a prospective study for which patients not prescribed chronic pain medication (defined as not using narcotic medications in 3 months prior to surgery) and presenting for surgery would be recruited. Preop administration of sedating medications (i.e. midazolam) would be avoided. On the day of surgery, once in OR and standard ASA monitors placed, a standardized dose of 2mcg/kg ideal body weight IV fentanyl is administered. The patient is then monitored for respiratory depression for 5 minutes prior to administration of additional induction agents. [would include respiratory rate, with RR < 10, or O2 Sat < 90%]. Would not provide supplemental oxygen during this time unless patient was already on supplemental oxygen. Patient would then be preoxygenated and general anesthesia induced. Once general anesthesia is induced, a blood sample is collected and stored. [sample could also be collected in preop upon IV placement]. Blood will be tested for Single Nucleotide Polymorphisms of genes related to opioid-induced analgesia. [Potential target genes listed in 7.0-1] This genomic data will be evaluated for any correlations of the presence of opioid-related SNPs and concomitant opioid-induced respiratory depression.
- Conditions
- Respiratory Depression
- Being tested
- Fentanyl
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Denpax, Durogesic
After the patient is attached to an ASA non-invasive monitor, a dose (2mcg/kg) of Fentanyl will be administered.
Groups compared would include patients experiencing respiratory depression vs those not experiencing respiratory depression after fentanyl administration. Their samples would be evaluated for any differences in genetic make-up concerning selected, known sequences affecting opioid-induced analgesia.
| Study group | Role | What they receive |
|---|---|---|
| ASA Patients I | Age 18-80 years old, English-speaking, not on current Fentanyl/opioid therapy, no use of opioid medications in the 3 months prior to surgery, scheduled for elective surgery at UAB main.
A normal healthy patient Healthy, non-smoking, no or minimal alcohol use Receives: Drug: Fentanyl | |
| ASA Patients III | Age 18-80 years old, English-speaking, not on current Fentanyl/opioid therapy, no use of opioid medications in the 3 months prior to surgery, scheduled for elective surgery at UAB main.
A patient with severe systemic disease Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of MI, CVA, TIA, or CAD/stents. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Nucleotide Polymorphisms
Preop-Blood will be tested for Single Nucleotide Polymorphisms of genes related to opioid-induced analgesia
Measured: 5 min Preop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start30 Oct 2018
- Primary completion21 May 2025
- Study completion21 May 2025
Why it stopped: Investigator decision
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Harrod, University of Alabama at Birmingham
- Investigators
- Tim Ness, MD, PhD, Study chair, UAB Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441282
- Sponsor's protocol ID
- F23456789
- Other IDs
- UAB
- Status last verified
- May 2025
- First submitted
- 15 Feb 2018
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 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
- NCT03441282
- Acronym / sponsor ID
- F23456789
- Conditions
- Respiratory Depression
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator decision
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 22 Feb 2018 (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.
The concept of precision medicine - taking individual variability into account when planning preventions and interventions - is not new but is quickly gaining attention in this age of powerful methodology of patient characterization and development of tools to analyze large sets of data. Oncology is the most obvious field in which this information has been readily applied. Increasing focus, nationally and internationally, on developing broad databases of patient genetic information and research efforts evaluating those data will, hopefully, lead to the development and application of evidence-based data enhancing the practice of all fields of medicine. It has yet to become obvious how this information can best be applied to the field of anesthesiology. Most genomics work in anesthesia has been focused in the area of pain medicine. There is a known genetic influence on the potency of opioid-induced analgesia, however; a genetic component of opioid-induced respiratory depression has yet to be thoroughly evaluated. Respiratory depression plays a role in clinical care - from procedures requiring sedation with monitored anesthesia care to treating post-opertative pain and chronic pain - but perhaps its largest current role in the public arena is the unfortunate deaths caused by side effects due to drug overdose.
Personalized medicine remains on the horizon for the field of anesthesia, but, as genetic testing becomes more affordable and mainstream in clinical practice, the potential applications are broad. Most readily would be its incorporation into development of patient specific pain regimens. Respiratory depression is a potentially lethal side effect of opioid therapy. 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.
Detailed description
This would be a prospective study for which patients not prescribed chronic pain medication (defined as not using narcotic medications in 3 months prior to surgery) and presenting for surgery would be recruited. Preop administration of sedating medications (i.e. midazolam) would be avoided. On the day of surgery, once in OR and standard ASA monitors placed, a standardized dose of 2mcg/kg ideal body weight IV fentanyl is administered. The patient is then monitored for respiratory depression for 5 minutes prior to administration of additional induction agents. [would include respiratory rate, with RR < 10, or O2 Sat < 90%]. Would not provide supplemental oxygen during this time unless patient was already on supplemental oxygen. Patient would then be preoxygenated and general anesthesia induced. Once general anesthesia is induced, a blood sample is collected and stored. [sample could also be collected in preop upon IV placement]. Blood will be tested for Single Nucleotide Polymorphisms of genes related to opioid-induced analgesia. [Potential target genes listed in 7.0-1] This genomic data will be evaluated for any correlations of the presence of opioid-related SNPs and concomitant opioid-induced respiratory depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASA Patients I | – | Drug: FentanylAge 18-80 years old, English-speaking, not on current Fentanyl/opioid therapy, no use of opioid medications in the 3 months prior to surgery, scheduled for elective surgery at UAB main. A normal healthy patient Healthy, non-smoking, no or minimal alcohol use |
| ASA Patients III | – | Drug: FentanylAge 18-80 years old, English-speaking, not on current Fentanyl/opioid therapy, no use of opioid medications in the 3 months prior to surgery, scheduled for elective surgery at UAB main. A patient with severe systemic disease Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of MI, CVA, TIA, or CAD/stents. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the OR schedule and recruit/consent patients in the preop clinic or preop holding area during preop evaluation.
Key inclusion criteria (5 listed)
- Age 18-80 years old,
- English-speaking,
- Not on current opioid therapy,
- ASA I-III,
- Scheduled for elective surgery at UAB main
Key exclusion criteria (2 listed)
- Chronic opioid therapy [Consistent use of opioid meds 3 months prior to surgery]
- pregnancy
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 |
|---|---|---|
| FentanylAlso: Denpax, DurogesicAfter the patient is attached to an ASA non-invasive monitor, a dose (2mcg/kg) of Fentanyl will be administered. Groups compared would include patients experiencing respiratory depression vs those not experiencing respiratory depression after fentanyl administration. Their samples would be evaluated for any differences in genetic make-up concerning selected, known sequences affecting opioid-induced analgesia. | Drug | ASA Patients I, ASA Patients III |
Primary outcome
Single Nucleotide Polymorphisms
Time frame: 5 min Preop
Preop-Blood will be tested for Single Nucleotide Polymorphisms of genes related to opioid-induced analgesia
Results and safety
The study was stopped early (reason given: Investigator decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Tim Ness, MD, PhD study chair
UAB Anesthesiology and Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Depression, run by University of Alabama at Birmingham at 1 site in United States.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Investigator decision). Results are not available in the source record.
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?
Single Nucleotide Polymorphisms (time frame: 5 min Preop). 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 25 May 2025.