Dexmedetomidine to Treat Bariatric Surgery-associated Pain
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Fentanyl; Morphine; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Sublimaze
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent; Bariatric; Obesity; Pain; Opiate-sparing