Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT00857727
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2009-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JiKim@chpnet.org', 'phone': '212-523-6121', 'title': 'Dr. Jinu Kim', 'organization': "Mount Sinai St. Luke's"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Methodology used cannot determine whether undescribed prolonged effect of DEX is related to the DEX or to increased activity levels in the placebo group.'}}, 'adverseEventsModule': {'description': 'Two adverse events were noted requiring unblinding', 'eventGroups': [{'id': 'EG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Severe bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Excessive sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Emergence Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'title': 'ED', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'No ED', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15-45 minutes post-op', 'description': '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).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'timeFrame': '24 hours', 'description': 'Vital signs were not collected as part of research study.', 'reportingStatus': 'POSTED', 'populationDescription': 'data were not collected'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '199', 'spread': '71', 'groupId': 'OG000'}, {'value': '215', 'spread': '156', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '43', 'groupId': 'OG000'}, {'value': '86', 'spread': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.55', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Total Study Drug used', 'unitOfMeasure': 'mcg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Sevoflurane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '6.80', 'spread': '7.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Total Drug used', 'unitOfMeasure': 'ml/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Propofol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '2.11', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Total Drug used', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Fentanyl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Total Drug used', 'unitOfMeasure': 'mcg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '33 children undergoing general anesthesia for endovascular interventional procedures. 28 patients provided complete data sets.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug', 'description': 'Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Normal Saline IV solution - Given by a continuous infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '4.2', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-23', 'studyFirstSubmitDate': '2009-03-06', 'resultsFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2009-03-06', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-23', 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Emergence Delirium', 'timeFrame': '15-45 minutes post-op', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU', 'timeFrame': '24 hours', 'description': 'Vital signs were not collected as part of research study.'}, {'measure': 'Weight', 'timeFrame': 'Baseline'}, {'measure': 'Length of Anesthesia', 'timeFrame': 'Day 1'}, {'measure': 'Length of Surgery', 'timeFrame': 'Day 1'}, {'measure': 'Total Study Drug', 'timeFrame': 'Day 1', 'description': 'Total Study Drug used'}, {'measure': 'Total Sevoflurane', 'timeFrame': 'Day 1', 'description': 'Total Drug used'}, {'measure': 'Total Propofol', 'timeFrame': 'Day 1', 'description': 'Total Drug used'}, {'measure': 'Total Fentanyl', 'timeFrame': 'Day 1', 'description': 'Total Drug used'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Emergence Delirium', 'Agitation', 'Pediatric', 'Anesthesia'], 'conditions': ['Agitation', 'Anesthesia', 'Pediatrics']}, 'referencesModule': {'references': [{'pmid': '17359402', 'type': 'BACKGROUND', 'citation': 'Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6. doi: 10.1111/j.1460-9592.2006.02100.x.'}, {'pmid': '16879517', 'type': 'BACKGROUND', 'citation': 'Isik B, Arslan M, Tunga AD, Kurtipek O. Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery. Paediatr Anaesth. 2006 Jul;16(7):748-53. doi: 10.1111/j.1460-9592.2006.01845.x.'}, {'pmid': '16101707', 'type': 'BACKGROUND', 'citation': 'Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.'}, {'pmid': '14693585', 'type': 'BACKGROUND', 'citation': 'Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.'}, {'pmid': '16566567', 'type': 'BACKGROUND', 'citation': 'Walker J, Maccallum M, Fischer C, Kopcha R, Saylors R, McCall J. Sedation using dexmedetomidine in pediatric burn patients. J Burn Care Res. 2006 Mar-Apr;27(2):206-10. doi: 10.1097/01.BCR.0000200910.76019.CF.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDexmedetomidine 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.\n\nThere 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children age 6 months through 17 years of age undergoing interventional neuroradiologic procedures at our hospital under general anesthesia\n* Patients classify as an ASA (American Society of Anesthesiologists) I-III\n* Have not received anesthetic for over 30 days from previous procedures\n\nExclusion Criteria:\n\n* Receiving digoxin therapy from the study\n* Severe congestive heart failure or pulmonary hypertension requiring vasodilators\n* Disease processes other than that associated with their intracranial pathology, such as hepatic or renal dysfunction'}, 'identificationModule': {'nctId': 'NCT00857727', 'acronym': 'DexPeds', 'briefTitle': 'Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's-Roosevelt Hospital Center"}, 'officialTitle': 'Use of Dexmedetomidine for Emergence Delirium in Children Undergoing General Anesthesia for Endovascular Interventional Neuroradiologic Procedures', 'orgStudyIdInfo': {'id': 'Dex Peds 08-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug', 'description': 'Dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Normal Saline IV solution', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': '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', 'armGroupLabels': ['Drug']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Phosphate buffered saline', 'PBS'], 'description': 'Given by a continuous infusion', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St Luke's-Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jolie Narang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's-Roosevelt Hospital Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's-Roosevelt Hospital Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}