Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT02162433
Status:
TERMINATED
Last Update Posted:
2020-04-09
First Post:
2014-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D014069', 'term': 'Tonsillitis'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'makara_cayer@meei.harvard.edu', 'phone': '617-573-3380', 'title': 'Dr. Makara Cayer', 'organization': 'Massachusetts Eye and Ear'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours post-op', 'eventGroups': [{'id': 'EG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 13, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 15, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 17, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post-extubation persistent cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PACU persistent cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-extubation low SaO2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PACU low SaO2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Extubation Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PACU stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Extubation Croup', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PACU Croup', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Extubation Breath Holding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PACU Breath Holding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsil Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Respiratory Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'OG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Number of patients exhibiting any of the following outcomes:\n\n1. desaturation to less than 95% for more than 10 seconds;\n2. breath holding;\n3. complete or partial laryngospasm;\n4. bronchospasm;\n5. croup;\n6. number of episodes of persistent cough (three or more consecutive coughs);\n7. negative pressure pulmonary edema;\n8. stridor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Emergence Agitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'OG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': "Number of patients with an incidence of emergence agitation post-surgery defined by the Pediatric Anesthesia Emergence Delirium (PAED) scale of \\>10.\n\nEmergence agitation is characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness. The PAED is a scale used to assess emergence agitation in our patient population. It's minimum value is zero and maximum value is 20, with 0 being no emergence agitation and 20 being the most agitated state.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Nausea and Vomiting (PONV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'OG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hrs', 'description': 'Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Time From End of Surgery to Leaving the Operating Room', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'OG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.15', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '18.05', 'spread': '7.43', 'groupId': 'OG001'}, {'value': '10.29', 'spread': '3.73', 'groupId': 'OG002'}, {'value': '11.77', 'spread': '5.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'OG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '345.06', 'spread': '91.23', 'groupId': 'OG000'}, {'value': '320.19', 'spread': '69.07', 'groupId': 'OG001'}, {'value': '341.53', 'spread': '73.85', 'groupId': 'OG002'}, {'value': '328.05', 'spread': '93.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hrs', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Needing Follow-up Pain Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'OG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': '24-hour postoperative pain medication requirement assessed by a parental questionnaire administered 24 hours after discharge. The parents are asked whether their child took any pain medication within the last 24 hours since the surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Unplanned Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'OG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'OG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Any unplanned hospital admission due to perioperative respiratory adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'FG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'FG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'FG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '1. Awake Extubation/Dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'BG001', 'title': '2. Awake Extubation/Placebo', 'description': 'Awake extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'BG002', 'title': '3.Deep Extubation/Dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.\n\nDexmedetomidine: to arms 1,3'}, {'id': 'BG003', 'title': '4. Deep Extubation/Placebo', 'description': 'Deep extubation receiving placebo (normal saline).\n\nNormal Saline: to arms 2,4. Serves as the placebo.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6.64', 'spread': '3.21', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '2.89', 'groupId': 'BG001'}, {'value': '6.52', 'spread': '2.79', 'groupId': 'BG002'}, {'value': '6.64', 'spread': '2.8', 'groupId': 'BG003'}, {'value': '6.48', 'spread': '2.94', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-29', 'size': 695457, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-05T14:11', 'hasProtocol': False}, {'date': '2018-01-29', 'size': 1085407, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-05T14:20', 'hasProtocol': True}, {'date': '2020-02-07', 'size': 191641, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-10T17:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'whyStopped': 'Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2014-06-10', 'resultsFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2014-06-11', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-08', 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Respiratory Complications', 'timeFrame': '24 hours', 'description': 'Number of patients exhibiting any of the following outcomes:\n\n1. desaturation to less than 95% for more than 10 seconds;\n2. breath holding;\n3. complete or partial laryngospasm;\n4. bronchospasm;\n5. croup;\n6. number of episodes of persistent cough (three or more consecutive coughs);\n7. negative pressure pulmonary edema;\n8. stridor.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Emergence Agitation', 'timeFrame': '24 hours', 'description': "Number of patients with an incidence of emergence agitation post-surgery defined by the Pediatric Anesthesia Emergence Delirium (PAED) scale of \\>10.\n\nEmergence agitation is characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness. The PAED is a scale used to assess emergence agitation in our patient population. It's minimum value is zero and maximum value is 20, with 0 being no emergence agitation and 20 being the most agitated state."}, {'measure': 'Number of Participants With Postoperative Nausea and Vomiting (PONV)', 'timeFrame': '24 hrs', 'description': 'Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.'}, {'measure': 'Average Time From End of Surgery to Leaving the Operating Room', 'timeFrame': '24 hours'}, {'measure': 'The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)', 'timeFrame': '24 hrs'}, {'measure': 'Number of Participants Needing Follow-up Pain Medication', 'timeFrame': '24 hours', 'description': '24-hour postoperative pain medication requirement assessed by a parental questionnaire administered 24 hours after discharge. The parents are asked whether their child took any pain medication within the last 24 hours since the surgery.'}, {'measure': 'Number of Patients With Unplanned Hospital Admission', 'timeFrame': '24 hours', 'description': 'Any unplanned hospital admission due to perioperative respiratory adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adenotonsillar Hypertrophy', 'Obstructive Sleep Apnea', 'Tonsillitis', 'Adenoiditis']}, 'descriptionModule': {'briefSummary': 'The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.', 'detailedDescription': 'We propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to Massachusetts Eye and Ear Infirmary (MEEI) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. A Clinical Pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. The anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the Clinical Pharmacy specialist. Multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty\n* ASA 1 \\& 2\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity reaction to dexmedetomidine\n* Organ dysfunction (renal/hepatic failure or leukemia)\n* Cardiac disease (congenital or acquired)\n* Airway or thoracic malformation\n* Cerebral palsy\n* Hypotonia\n* Need for premedication\n* Current/recent upper respiratory infection (within four weeks prior to the surgery)\n* Asthma\n* Allergy or intolerance to clonidine\n* Non-English speaking parents/patients.'}, 'identificationModule': {'nctId': 'NCT02162433', 'briefTitle': 'The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Does Dexmedetomidine Decrease the Incidence of Untoward Airway Events After Deep or Awake Extubation in Patients Undergoing Adenotonsillectomy With or Without Myringotomy and Tube Placement?', 'orgStudyIdInfo': {'id': '14-019H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. Awake extubation/dexmedetomidine', 'description': 'Awake extubation receiving dexmedetomidine.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2. Awake extubation/placebo', 'description': 'Awake extubation receiving placebo (normal saline).', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3.Deep extubation/dexmedetomidine', 'description': 'Deep extubation receiving dexmedetomidine.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4. Deep extubation/placebo', 'description': 'Deep extubation receiving placebo (normal saline).', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['0.9% Sodium Chloride Solution'], 'description': 'to arms 2,4. Serves as the placebo.', 'armGroupLabels': ['2. Awake extubation/placebo', '4. Deep extubation/placebo']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'to arms 1,3', 'armGroupLabels': ['1. Awake extubation/dexmedetomidine', '3.Deep extubation/dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MEEI', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Makara Cayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MEEI/ Harvard Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts Eye and Ear Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicpal Investigator', 'investigatorFullName': 'Makara Cayer', 'investigatorAffiliation': 'Massachusetts Eye and Ear Infirmary'}}}}