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Dexmedetomidine to Treat Bariatric Surgery-associated Pain

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02880540
Enrollment
26
Registered
2016-08-26
Start date
2016-03-31
Completion date
2018-02-28
Last updated
2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Adolescent, Bariatric, Obesity, Pain, Opiate-sparing

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.

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

Interventions

DRUGFentanyl
DRUGMorphine
DRUGDexmedetomidine

Sponsors

Janelle Vaughns
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Scores (Numerical Rating Scale 0-10) Using the Faces Pain Scale-RevisedFrom 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.

Countries

United States

Participant flow

Recruitment details

We identified 13 patients who had received dexmedetomidine intraoperatively during the course of laporoscopic sleeve gastrectomy.

Participants by arm

ArmCount
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 Fentanyl Morphine
13
Dexmedetomidine Treated
Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery Dexmedetomidine
13
Total26

Baseline characteristics

CharacteristicControl GroupDexmedetomidine TreatedTotal
Age, Categorical
<=18 years
13 Participants13 Participants26 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous16 years18 years17 years
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants0 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants12 Participants18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Region of Enrollment
United States
13 participants13 participants26 participants
Sex: Female, Male
Female
11 Participants8 Participants19 Participants
Sex: Female, Male
Male
2 Participants5 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 13
other
Total, other adverse events
0 / 130 / 13
serious
Total, serious adverse events
0 / 130 / 13

Outcome results

Primary

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.

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

ArmMeasureValue (MEDIAN)
Control GroupPain Scores (Numerical Rating Scale 0-10) Using the Faces Pain Scale-Revised5 Units on a scale
Dexmedetomidine TreatedPain Scores (Numerical Rating Scale 0-10) Using the Faces Pain Scale-Revised3.4 Units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026