ObesityPhase 3NCT02880540
Dexmedetomidine to Treat Bariatric Surgery-associated Pain
A Phase 3 study testing Fentanyl, Morphine and Dexmedetomidine in people with Obesity, run by Janelle Vaughns at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fentanyl, Morphine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Feb 2018
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI ≥ 95th percentile.
- Hospitalized overnight after surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Obesity
- Being tested
- Fentanyl, Morphine, Dexmedetomidine
- Keywords
- Adolescent, Bariatric, Obesity, Pain, Opiate-sparing
- Medical subject headings
- Obesity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Sublimaze
MorphineDrug
DexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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 Receives: Drug: Fentanyl; Drug: Morphine |
| Dexmedetomidine Treated | Experimental | Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores (Numerical Rating Scale 0-10) Using the Faces Pain Scale-Revised
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.
Measured: From surgery until discharge from the hospital, an average of 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janelle Vaughns
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janelle Vaughns, Children's National Research Institute
- Investigators
- Celeste Martin, MD, Principal investigator, Childrens National Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880540
- Sponsor's protocol ID
- 00006562
- Status last verified
- Nov 2021
- First submitted
- 12 May 2016
- Last updated
- 7 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Freedman DS, Mei Z, Srinivasan SR, Berenson GS, Dietz WH. Cardiovascular risk factors and excess adiposity among overweight children and adolescents: the Bogalusa Heart Study. J Pediatr. 2007 Jan;150(1):12-17.e2. doi: 10.1016/j.jpeds.2006.08.042.
PubMed 17188605Thompson DR, Obarzanek E, Franko DL, Barton BA, Morrison J, Biro FM, Daniels SR, Striegel-Moore RH. Childhood overweight and cardiovascular disease risk factors: the National Heart, Lung, and Blood Institute Growth and Health Study. J Pediatr. 2007 Jan;150(1):18-25. doi: 10.1016/j.jpeds.2006.09.039.
PubMed 17188606Finkelstein EA, Fiebelkorn IC, Wang G. National medical spending attributable to overweight and obesity: how much, and who's paying? Health Aff (Millwood). 2003 Jan-Jun;Suppl Web Exclusives:W3-219-26. doi: 10.1377/hlthaff.w3.219.
PubMed 14527256Ogden CL, Yanovski SZ, Carroll MD, Flegal KM. The epidemiology of obesity. Gastroenterology. 2007 May;132(6):2087-102. doi: 10.1053/j.gastro.2007.03.052.
PubMed 17498505Inge TH, Krebs NF, Garcia VF, Skelton JA, Guice KS, Strauss RS, Albanese CT, Brandt ML, Hammer LD, Harmon CM, Kane TD, Klish WJ, Oldham KT, Rudolph CD, Helmrath MA, Donovan E, Daniels SR. Bariatric surgery for severely overweight adolescents: concerns and recommendations. Pediatrics. 2004 Jul;114(1):217-23. doi: 10.1542/peds.114.1.217.
PubMed 15231931Tsai WS, Inge TH, Burd RS. Bariatric surgery in adolescents: recent national trends in use and in-hospital outcome. Arch Pediatr Adolesc Med. 2007 Mar;161(3):217-21. doi: 10.1001/archpedi.161.3.217.
PubMed 17339501Adams JP, Murphy PG. Obesity in anaesthesia and intensive care. Br J Anaesth. 2000 Jul;85(1):91-108. doi: 10.1093/bja/85.1.91. No abstract available.
PubMed 10927998Benumof JL. Obesity, sleep apnea, the airway and anesthesia. Curr Opin Anaesthesiol. 2004 Feb;17(1):21-30. doi: 10.1097/00001503-200402000-00005.
PubMed 17021525Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
PubMed 21148651Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.
PubMed 16517328Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.
PubMed 18499604Mason KP, Lerman J. Review article: Dexmedetomidine in children: current knowledge and future applications. Anesth Analg. 2011 Nov;113(5):1129-42. doi: 10.1213/ANE.0b013e31822b8629. Epub 2011 Aug 4.
PubMed 21821507