Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children (DexPeds)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
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Agitation Anesthesia Pediatrics |
Drug: Dexmedetomidine Drug: Saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Use of Dexmedetomidine for Emergence Delirium in Children Undergoing General Anesthesia for Endovascular Interventional Neuroradiologic Procedures |
- We will assess emergence delirium utilizing the Cole scale, PAED scale, Objective Pain scale, and ActiCal. [ Time Frame: 2 and 24 hours ] [ Designated as safety issue: No ]
- Vital signs (heart rate, blood pressure, respiratory rate and pulse oximetry) will be continuously monitored in the PICU [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 128 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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Experimental: Drug
Dexmedetomidine
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Drug: Dexmedetomidine
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 Name: Precedex
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Placebo Comparator: Control
Normal Saline IV solution
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Drug: Saline
Given by a continuous infusion
Other Names:
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Henry L Bennett, Ph.D. | 212-523-8047 | hebennet@chpnet.org |
| United States, New York | |
| St Luke's-Roosevelt Hospital Center | Recruiting |
| New York, New York, United States, 10019 | |
| Contact: Henry Bennett, Ph.D. 212-523-8047 hebennet@chpnet.org | |
| Contact: Mehreen Haqqie, MBBS 917-664-7329 mehreen.haqqie@gmail.com | |
| Principal Investigator: Jolie Narang, M.D. | |
| Principal Investigator: | Jolie Narang, M.D. | St. Luke's-Roosevelt Hospital Center |
More Information
Publications:
| Responsible Party: | Jolie Narang, M.D., Associate Attending Anesthesiologist, St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT00857727 History of Changes |
| Other Study ID Numbers: | Dex Peds 08-088 |
| Study First Received: | March 6, 2009 |
| Last Updated: | June 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Luke's-Roosevelt Hospital Center:
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Dexmedetomidine Emergence Delirium Agitation Pediatric Anesthesia |
Additional relevant MeSH terms:
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Delirium Psychomotor Agitation Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dyskinesias Psychomotor Disorders Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013