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Completed

NCT Number: NCT02880540

Dexmedetomidine to Treat Bariatric Surgery-associated Pain

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.

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Key information

Conditions

Obesity Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

Other names: Sublimaze

Morphine

Drug

Dexmedetomidine

Drug

Primary outcomes

  1. Pain Scores (Numerical Rating Scale 0-10) Using the Faces Pain Scale-Revised

    Time frame: From surgery until discharge from the hospital, an average of 48 hours.

    Average pain scores during the day of surgery using the FPS-R rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain. Each level accompanies a facial expression, ranging from content to distress.

Sponsors and collaborators

Lead sponsor

Janelle Vaughns

Other

Registry information

Official study title

The Use of Dexmedetomidine as an Adjuvant for Perioperative Pain Management in Morbidly Obese Adolescents Undergoing Bariatric Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 26, 2016
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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