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Trial record 1 of 2 for:    17188606 [PUBMED-IDS]
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Dexmedetomidine to Treat Bariatric Surgery-associated Pain

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ClinicalTrials.gov Identifier: NCT02880540
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Janelle Vaughns, Children's Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Fentanyl Drug: Morphine Drug: Dexmedetomidine Phase 3

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Dexmedetomidine as an Adjuvant for Perioperative Pain Management in Morbidly Obese Adolescents Undergoing Bariatric Surgery
Study Start Date : March 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Fentanyl 50 micrograms IV every 15 minutes up to 3 doses in postanesthesia recovery room and Morphine 2mg IV every 2 hours for 2days on hospital floor
Drug: Fentanyl
Other Name: Sublimaze

Drug: Morphine
Experimental: Dexmedetomidine Treated
Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery
Drug: Dexmedetomidine



Primary Outcome Measures :
  1. Pharmacokinetics of Dexmedetomidine [ Time Frame: within 24hrs after dosing ]
    Renal Clearance


Secondary Outcome Measures :
  1. Pain intensity measure [ Time Frame: within 48hrs after dosing ]
    Pain level will be determined using a reportable pain assessment scaled score . A reported scale of between and including zero to ten will be used. Zero would mean no pain and ten describes a very high intolerable pain score.



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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880540


Contacts
Contact: Janelle Vaughns, MD 202 476 ext 4165 jvaughns@childrensnational.org
Contact: Elaine Williams, Ph.D 202 476 ext 2245 EFWillia@childrensnational.org

Locations
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Janelle Vaughns, MD    202-476-4165    jvaughns@cnmc.org   
Sponsors and Collaborators
Janelle Vaughns
Investigators
Principal Investigator: Celeste Martin, MD Childrens National Health System

Publications:

Responsible Party: Janelle Vaughns, Principal Investigator, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02880540     History of Changes
Other Study ID Numbers: 00006562
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Janelle Vaughns, Children's Research Institute:
Adolescent
Bariatric
Obesity
Pain
Opiate-sparing

Additional relevant MeSH terms:
Morphine
Fentanyl
Dexmedetomidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics