Precision Medicine in Anesthesia: Genetic Component in Opioid-induced Respiratory Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/1/2018 |
| Start Date: | October 30, 2018 |
| End Date: | November 15, 2021 |
| Contact: | Adam Sturdivant, MPH |
| Email: | Adamsturdivant@uabmc.edu |
| Phone: | 205-934-4042 |
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.
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.
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.
(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.
Inclusion Criteria:
- Age 18-80 years old,
- English-speaking,
- Not on current opioid therapy,
- ASA I-III,
- Scheduled for elective surgery at UAB main
Exclusion Criteria:
- Chronic opioid therapy [Consistent use of opioid meds 3 months prior to surgery]
- pregnancy
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-934-4042
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
