St Luke's-Roosevelt Hospital Center
New York, 10019, United States
NCT Number: NCT00857727
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.
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Notify Me6 month–17 year
All sexes
Interventional
Phase 3
New York, 10019, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexmedetomidine will be dissolved in saline. An initial loading dose of 1.0 mg/kg given over 10 minutes followed by a continuous infusion at 0.4-0.7 mg/kg/hour. Beginning approximately one hour prior to end of surgery and continuing for one hour of recovery in the PACU and the PICU. This, the maximum dose for any one patient will be 2.4 mg/kg
Other names: Precedex
Given by a continuous infusion
Other names: Phosphate buffered saline, PBS
Time frame: 15-45 minutes post-op
Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).
Time frame: 24 hours
Vital signs were not collected as part of research study.
Time frame: Baseline
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Total Study Drug used
Time frame: Day 1
Total Drug used
Time frame: Day 1
Total Drug used
Time frame: Day 1
Total Drug used
St. Luke's-Roosevelt Hospital Center
Other
Use of Dexmedetomidine for Emergence Delirium in Children Undergoing General Anesthesia for Endovascular Interventional Neuroradiologic Procedures
Acronym: DexPeds
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