Dexmedetomidine to Treat Bariatric Surgery-associated Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 20 |
| Updated: | 6/8/2017 |
| Start Date: | March 2016 |
| End Date: | September 2018 |
| Contact: | Janelle Vaughns, MD |
| Email: | jvaughns@childrensnational.org |
| Phone: | 202 476 |
The Use of Dexmedetomidine as an Adjuvant for Perioperative Pain Management in Morbidly Obese Adolescents Undergoing Bariatric Surgery
Obesity represents one of the most important public health issues according to the World
Health Organization and it has reached epidemic proportions globally. The prevalence of
childhood obesity has rapidly increased over the past decade and is associated with multiple
co-morbid disease states . It is estimated that approximately 15.5% of children and
adolescents are obese with a body mass index of ≥95th percentile for age . This not only
poses health concerns for the patient, but also places increased demands on our healthcare
system that is already overwhelmed by burgeoning costs. Moreover, obese children and
adolescents who maintain excessive weight as adults are predisposed to cardiovascular
disease and premature death.
In carefully selected patients who have failed to lose weight by diet and exercise,
bariatric surgery provides an option to obtaining a healthy weight.
It is increasingly becoming an attractive option, with the number of adolescents undergoing
bariatric surgery in the United States tripling between 2000 and 2003.
Obese patients are often afflicted with multi-organ dysfunction and obstructive sleep apnea,
which presents unique challenges to the anesthesiologist managing their perioperative care .
Bariatric surgery in obese adolescents may be associated with significant postoperative
pain. Potent intravenous opioids such as fentanyl and morphine are at the mainstay of
perioperative pain management. Unfortunately, respiratory depression and airway obstruction
can often occur following administration of opioids in obese patients . This makes providing
a safe analgesic regimen difficult during the perioperative setting. As opioids can be
associated with respiratory depression and upper airway obstruction, surgeons and
anesthesiologists alike must reconcile the adequacy of pain control with the risk of
respiratory complications after surgery in obese adolescents.
Health Organization and it has reached epidemic proportions globally. The prevalence of
childhood obesity has rapidly increased over the past decade and is associated with multiple
co-morbid disease states . It is estimated that approximately 15.5% of children and
adolescents are obese with a body mass index of ≥95th percentile for age . This not only
poses health concerns for the patient, but also places increased demands on our healthcare
system that is already overwhelmed by burgeoning costs. Moreover, obese children and
adolescents who maintain excessive weight as adults are predisposed to cardiovascular
disease and premature death.
In carefully selected patients who have failed to lose weight by diet and exercise,
bariatric surgery provides an option to obtaining a healthy weight.
It is increasingly becoming an attractive option, with the number of adolescents undergoing
bariatric surgery in the United States tripling between 2000 and 2003.
Obese patients are often afflicted with multi-organ dysfunction and obstructive sleep apnea,
which presents unique challenges to the anesthesiologist managing their perioperative care .
Bariatric surgery in obese adolescents may be associated with significant postoperative
pain. Potent intravenous opioids such as fentanyl and morphine are at the mainstay of
perioperative pain management. Unfortunately, respiratory depression and airway obstruction
can often occur following administration of opioids in obese patients . This makes providing
a safe analgesic regimen difficult during the perioperative setting. As opioids can be
associated with respiratory depression and upper airway obstruction, surgeons and
anesthesiologists alike must reconcile the adequacy of pain control with the risk of
respiratory complications after surgery in obese adolescents.
Dexmedetomidine is a non-opioid drug that has shown some utility during bariatric surgery in
the adult population because of its analgesic properties. It is a lipophilic imidazole
derivative that is a selective α2-adrenoreceptor agonist with sedative and analgesic
properties devoid of respiratory depressant effects . Dexmedetomidine produces sedation by
modulating the release of the neurotransmitter norepinephrine within the locus coeruleus of
the brain, which is vital to producing an awake state. In addition, by directly stimulating
α2-receptors in the spinal cord, dexmedetomidine inhibits the firing of nociceptive neurons
responsible for the propagation of pain signals.
Although dexmedetomidine is an agent with many off-label clinical applications in the
pediatric setting, much about its pharmacokinetic and pharmacodynamics properties remain
unknown. This is even more evident for pediatric patients that are obese. Currently, there
are no reported pharmacokinetic and pharmacodynamic studies that have investigated
dexmedetomidine in obese children and adolescents. Our previous experience with the use of
dexmedetomidine in the perioperative period along with our robust obese surgical population
certainly supports the notion that we are well poised to conduct the proposed trial
the adult population because of its analgesic properties. It is a lipophilic imidazole
derivative that is a selective α2-adrenoreceptor agonist with sedative and analgesic
properties devoid of respiratory depressant effects . Dexmedetomidine produces sedation by
modulating the release of the neurotransmitter norepinephrine within the locus coeruleus of
the brain, which is vital to producing an awake state. In addition, by directly stimulating
α2-receptors in the spinal cord, dexmedetomidine inhibits the firing of nociceptive neurons
responsible for the propagation of pain signals.
Although dexmedetomidine is an agent with many off-label clinical applications in the
pediatric setting, much about its pharmacokinetic and pharmacodynamics properties remain
unknown. This is even more evident for pediatric patients that are obese. Currently, there
are no reported pharmacokinetic and pharmacodynamic studies that have investigated
dexmedetomidine in obese children and adolescents. Our previous experience with the use of
dexmedetomidine in the perioperative period along with our robust obese surgical population
certainly supports the notion that we are well poised to conduct the proposed trial
Inclusion Criteria:
- BMI ≥ 95th percentile.
- Hospitalized overnight after surgery
Exclusion Criteria:
- History or a family (parent or sibling) history of malignant hyperthermia
- Renal or hepatic disorders
- Allergy to opioid analgesics
- An allergy to α2-adrenergic agonists or sulfa drugs
- Uncontrolled hypertension
- Clinically significant neurologic diseases
- Pregnancy or lactating female
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