Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children



Status:Completed
Conditions:Hospital, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:Any - 17
Updated:11/29/2018
Start Date:August 2009
End Date:December 2011

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Use of Dexmedetomidine for Emergence Delirium in Children Undergoing General Anesthesia for Endovascular Interventional Neuroradiologic Procedures

Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population
undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine
versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical
population.

Emergence delirium from general anesthesia is a common problem in the pediatric population
with a reported incidence of up to 80%. In addition to being jarring to children and their
parents, ED can cause significant physical harm, particularly to the surgical site. ED is
also associated with accidental removal of surgical dressings and drains, intravenous and
intra-arterial catheters, increased nursing care, extended recovery room stays, and delayed
reunion with parents. Emergence delirium is especially associated with sevoflurane, the most
commonly used inhalation anesthetic in pediatrics. At present, there is no single definition
of pediatric ED because of its heterogeneous clinical presentation. It has been described as
an acute phenomenon in which the child is irritable, uncompromising, uncooperative,
incoherent, and inconsolably crying, moaning, kicking or thrashing. Typically, these children
do not recognize or identify familiar objects or people, and often exhibit combative
behavior. Although ED is a self-limiting phenomenon, it is especially dangerous in the
interventional neuroradiologic patient whose femoral artery has been catheterized and must be
kept immobile in the immediate post-operative period. These patients also have multiple
intravenous and intra-arterial catheters which can be dislodged during an episode of ED.
Numerous pharmacologic agents including benzodiazepines, opioids, ketamine, and clonidine,
have been studied as prophylactic agents for ED but have met with varying success. Promising
results with the α-2 adrenergic agonist clonidine, have spurred interest in a new α-2
adrenergic agonist, dexmedetomidine.

Dexmedetomidine is highly selective for the 2A subtype of the central presynaptic α-2
adrenergic receptor which is associated with sedation and analgesia. It is currently approved
for use in adults as a sedative agent in intensive care units but has been used in myriad
other ways for sedation. As a sedative, dexmedetomidine is unusual in that it does not
depress respiratory drive because its actions are not mediated by the GABA-mimetic system.
The quality of sedation produced by dexmedetomidine is unique, and has been described as
"cooperative sedation," in which patients can interact with healthcare providers and follow
verbal commands. This particular sedation profile permits a patient to be comfortably
sedated, yet cooperate for an accurate neurological exam. The most extreme example of this is
the awake craniotomy, in which a patient undergoes a neurological examination during surgery.
In addition to being sedative, dexmedetomidine is also analgesic and suppresses shivering,
making it especially useful in the perioperative period.

There have been studies suggesting a use for dexmedetomidine in ED yet none have examined its
use in the pediatric neurosurgical population. Treatment of ED in pediatric neurosurgical
patients involves balancing the need for smooth emergence with the need for accurate
neurological exams. Benzodiazepines and opioids are currently used to treat ED but are
long-acting, interfere with neurological exams, and carry the risks of respiratory
depression, nausea, vomiting, and acute tolerance. Dexmedetomidine provides an alternative to
current treatment modalities for ED, which does not interfere with neurological exams.

Inclusion Criteria:

- Children age 6 months through 17 years of age undergoing interventional
neuroradiologic procedures at our hospital under general anesthesia

- Patients classify as an ASA (American Society of Anesthesiologists) I-III

- Have not received anesthetic for over 30 days from previous procedures

Exclusion Criteria:

- Receiving digoxin therapy from the study

- Severe congestive heart failure or pulmonary hypertension requiring vasodilators

- Disease processes other than that associated with their intracranial pathology, such
as hepatic or renal dysfunction
We found this trial at
1
site
1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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New York, NY
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