Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-25 @ 2:26 AM
Study NCT ID:
NCT02038894
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2013-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mario.patino@cchcm.org', 'phone': '5132538190', 'title': 'Dr. Mario Patino', 'organization': "Cincinnati Children's Hospital Medical Center"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'prior to conclusion. THis is optional'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intubated With Sevoflurane (IS)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.', 'otherNumAtRisk': 60, 'otherNumAffected': 1, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intubated With Propofol (IP)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.', 'otherNumAtRisk': 58, 'otherNumAffected': 4, 'seriousNumAtRisk': 58, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Native Airway - no Intubation', 'description': 'Anesthetic technique during (EGD)\n\nZofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.\n\nPropofol', 'otherNumAtRisk': 61, 'otherNumAffected': 24, 'seriousNumAtRisk': 61, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Minor desaturation < 95%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inadequate anesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Severe desaturation: SpO2 < 85%', 'notes': 'A recorded SpO2 \\< 85% during the anesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Respiratory Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '119', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Intubated With Sevoflurane (IS)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.'}, {'id': 'OG001', 'title': 'Intubated With Propofol (IP)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.'}, {'id': 'OG002', 'title': 'Native Airway - no Intubation', 'description': 'Anesthetic technique during (EGD)\n\nZofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.\n\nPropofol'}, {'id': 'OG003', 'title': 'IS and IP', 'description': 'Grouping the intubated with sevoflurane group (IS) with the intubated with propofol group (IP) since the airway management is the same for both groups (endotracheal intubation) Table 2'}, {'id': 'OG004', 'title': 'IP and NA', 'description': 'Grouping the intubated propofol group (IP) with the native airway group (NA) since they received the same medication during the procedure (propofol). Table 2'}], 'classes': [{'title': 'SPO2 < 95%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'SPO2 < 85%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Apnea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Inadequate Anesthesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'All Respiratory Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0.14', 'pValueComment': 'Threshold for significance \\<0.05 Comparing SPO2 \\<95%', 'statisticalMethod': 'Mean equality test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A previous study for evaluating respiratory complications with intubated and insufflated techniques found a difference in the incidence of respiratory complications of 9.1%, a power analysis was determined. 200 subjects per group was estimated provide 82% power to detect a difference. We elected to do an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0.27', 'pValueComment': 'p\\<0.05. Sp02\\<85%', 'estimateComment': 'Odds ratios were calculated to the respiratory complications comparing the different groups and by regrouping by the differences in airway management (IS + IP vs NA) and by the medication used for anesthesia maintenance (IS vs IP + NA)', 'statisticalMethod': 'Mean equality test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A previous study found an incidence of respiratory complications of 9.1%. 200 subjects per group was estimated provide 82% power to detect a difference when conducting a two- sided test at a significance level of a = 0.05.We did an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications. Based on the results of that interim analysis, recruitment was discontinued'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Admission for surgery through recovery period, approximately 3 hours', 'description': "An important outcome in the anesthetic management of these patients is to maintain a balance between a safe technique with a minimal incidence of respiratory complications, and a technique that facilitates rapid turnover of the gastrointestinal suite. A chi-square test, or Fisher's exact test will measure differences among the three anesthetic groups. Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peri-operative Times Between Three Different Anesthetic Techniques', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '119', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Intubated With Sevoflurane (IS)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.'}, {'id': 'OG001', 'title': 'Intubated With Propofol (IP)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.'}, {'id': 'OG002', 'title': 'Native Airway - no Intubation', 'description': 'Anesthetic technique during (EGD)\n\nZofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.\n\nPropofol'}, {'id': 'OG003', 'title': 'IS and IP', 'description': 'Grouped together by the same airway management during anesthesia (Endotracheal intubation). Table 2'}, {'id': 'OG004', 'title': 'IP and NA', 'description': 'Grouped together by the same medication use for anesthesia maintenance (propofol). Table 2'}], 'classes': [{'title': 'OR Time', 'categories': [{'measurements': [{'value': '24.03', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '24.19', 'spread': '7.54', 'groupId': 'OG001'}, {'value': '23.05', 'spread': '7.97', 'groupId': 'OG002'}, {'value': '24.11', 'spread': '6.77', 'groupId': 'OG003'}, {'value': '23.61', 'spread': '7.75', 'groupId': 'OG004'}]}]}, {'title': 'Anesthesia Preparation Time', 'categories': [{'measurements': [{'value': '10.86', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '10.70', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '10.35', 'spread': '3.35', 'groupId': 'OG002'}, {'value': '10.78', 'spread': '2.60', 'groupId': 'OG003'}, {'value': '10.53', 'spread': '3.03', 'groupId': 'OG004'}]}]}, {'title': 'Procedural Time', 'categories': [{'measurements': [{'value': '9.07', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '9.23', 'spread': '5.46', 'groupId': 'OG001'}, {'value': '8.33', 'spread': '4.18', 'groupId': 'OG002'}, {'value': '9.15', 'spread': '5.11', 'groupId': 'OG003'}, {'value': '8.78', 'spread': '4.86', 'groupId': 'OG004'}]}]}, {'title': 'PACU efficiency time', 'categories': [{'measurements': [{'value': '49.50', 'spread': '14.31', 'groupId': 'OG000'}, {'value': '53.49', 'spread': '12.68', 'groupId': 'OG001'}, {'value': '54.42', 'spread': '22.59', 'groupId': 'OG002'}, {'value': '51.48', 'spread': '13.61', 'groupId': 'OG003'}, {'value': '53.96', 'spread': '18.24', 'groupId': 'OG004'}]}]}, {'title': 'Total Perioperative Time', 'categories': [{'measurements': [{'value': '75.34', 'spread': '15.40', 'groupId': 'OG000'}, {'value': '79.61', 'spread': '14.45', 'groupId': 'OG001'}, {'value': '79.37', 'spread': '25.17', 'groupId': 'OG002'}, {'value': '77.46', 'spread': '15.03', 'groupId': 'OG003'}, {'value': '79.49', 'spread': '20.43', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.901', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Threshold of Significance', 'groupDescription': 'Total OR Time', 'statisticalMethod': 'Mean equality test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'No previous data was available to calculate a power calculation for the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': 'Admission for surgery through recovery period, approximately 3 hours', 'description': 'Time measurements are used to evaluate the efficiency of the different techniques. We will compare the times spent in the operating room and the postoperative unit for each technique.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intubated With Sevoflurane (IS)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.'}, {'id': 'FG001', 'title': 'Intubated With Propofol (IP)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.'}, {'id': 'FG002', 'title': 'Native Airway - no Intubation', 'description': 'Anesthetic technique during (EGD)\n\nZofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.\n\nPropofol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Intubated With Sevoflurane (IS)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.'}, {'id': 'BG001', 'title': 'Intubated With Propofol (IP)', 'description': 'Anesthetic technique during (EGD)\n\nIntubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.'}, {'id': 'BG002', 'title': 'Native Airway - no Intubation', 'description': 'Anesthetic technique during (EGD)\n\nZofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.\n\nPropofol'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '7', 'groupId': 'BG003', 'lowerLimit': '4', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '15.9', 'upperLimit': '35.8'}, {'value': '22.7', 'groupId': 'BG001', 'lowerLimit': '17.8', 'upperLimit': '31.8'}, {'value': '22.5', 'groupId': 'BG002', 'lowerLimit': '16.5', 'upperLimit': '37.7'}, {'value': '24.3', 'groupId': 'BG003', 'lowerLimit': '16.4', 'upperLimit': '35.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000', 'lowerLimit': '14.9', 'upperLimit': '17.9'}, {'value': '16.1', 'groupId': 'BG001', 'lowerLimit': '14.8', 'upperLimit': '17.4'}, {'value': '16.6', 'groupId': 'BG002', 'lowerLimit': '15.3', 'upperLimit': '18.4'}, {'value': '16.4', 'groupId': 'BG003', 'lowerLimit': '15', 'upperLimit': '17.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'BMI Percent', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '21.6', 'upperLimit': '78.2'}, {'value': '57.1', 'groupId': 'BG001', 'lowerLimit': '24.6', 'upperLimit': '76.9'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '39.9', 'upperLimit': '83.7'}, {'value': '56.8', 'groupId': 'BG003', 'lowerLimit': '25.3', 'upperLimit': '81.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentile', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': "American Society of Anesthesiologists - ASA Physical Status (Patient's health condition)", 'classes': [{'categories': [{'title': 'ASA 1 (Normal healthy subject)', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'ASA 2 (Mild systemic disease)', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}, {'title': 'Missing or Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Abdominal Pain', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Chronic Diarrhea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Dysphagia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Eosinophilic esophagitis', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}, {'title': 'Failure to Thrive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Feeding Difficulties', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'GERD', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Nausea/Vomit', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Rumination Syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2013-05-01', 'resultsFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-23', 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Respiratory Complications', 'timeFrame': 'Admission for surgery through recovery period, approximately 3 hours', 'description': "An important outcome in the anesthetic management of these patients is to maintain a balance between a safe technique with a minimal incidence of respiratory complications, and a technique that facilitates rapid turnover of the gastrointestinal suite. A chi-square test, or Fisher's exact test will measure differences among the three anesthetic groups. Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience."}], 'secondaryOutcomes': [{'measure': 'Peri-operative Times Between Three Different Anesthetic Techniques', 'timeFrame': 'Admission for surgery through recovery period, approximately 3 hours', 'description': 'Time measurements are used to evaluate the efficiency of the different techniques. We will compare the times spent in the operating room and the postoperative unit for each technique.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthetic', 'Pediatric', 'Esophagogastroduodenoscopies', 'Eosinophilic esophagitis', 'Gastroesophageal reflux disease (GERD)', 'Abdominal Pain', 'Vomiting', 'Sevofluorane', 'Propofol', 'Nasal cannula', 'Intubation', 'Endotracheal tube'], 'conditions': ['Eosinophilic Esophagitis']}, 'referencesModule': {'references': [{'pmid': '20716074', 'type': 'BACKGROUND', 'citation': 'Hoffmann CO, Samuels PJ, Beckman E, Hein EA, Shackleford TM, Overbey E, Berlin RE, Wang Y, Nick TG, Gunter JB. Insufflation vs intubation during esophagogastroduodenoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):821-30. doi: 10.1111/j.1460-9592.2010.03357.x.'}, {'pmid': '10078684', 'type': 'BACKGROUND', 'citation': 'Brown RH, Wagner EM. Mechanisms of bronchoprotection by anesthetic induction agents: propofol versus ketamine. Anesthesiology. 1999 Mar;90(3):822-8. doi: 10.1097/00000542-199903000-00025.'}, {'pmid': '16306725', 'type': 'BACKGROUND', 'citation': 'Oberer C, von Ungern-Sternberg BS, Frei FJ, Erb TO. Respiratory reflex responses of the larynx differ between sevoflurane and propofol in pediatric patients. Anesthesiology. 2005 Dec;103(6):1142-8. doi: 10.1097/00000542-200512000-00007.'}, {'pmid': '9768765', 'type': 'BACKGROUND', 'citation': 'Schwartz DA, Connelly NR, Theroux CA, Gibson CS, Ostrom DN, Dunn SM, Hirsch BZ, Angelides AG. Gastric contents in children presenting for upper endoscopy. Anesth Analg. 1998 Oct;87(4):757-60. doi: 10.1097/00000539-199810000-00003.'}, {'pmid': '18030225', 'type': 'BACKGROUND', 'citation': 'Lightdale JR, Mahoney LB, Schwarz SM, Liacouras CA. Methods of sedation in pediatric endoscopy: a survey of NASPGHAN members. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):500-2. doi: 10.1097/MPG.0b013e3180691168.'}, {'pmid': '11068839', 'type': 'BACKGROUND', 'citation': 'Elitsur Y, Blankenship P, Lawrence Z. Propofol sedation for endoscopic procedures in children. Endoscopy. 2000 Oct;32(10):788-91. doi: 10.1055/s-2000-7713.'}, {'pmid': '16951002', 'type': 'BACKGROUND', 'citation': 'Cravero JP, Blike GT, Beach M, Gallagher SM, Hertzog JH, Havidich JE, Gelman B; Pediatric Sedation Research Consortium. Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006 Sep;118(3):1087-96. doi: 10.1542/peds.2006-0313.'}, {'pmid': '17767636', 'type': 'BACKGROUND', 'citation': 'Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.'}, {'pmid': '17258979', 'type': 'BACKGROUND', 'citation': 'Thakkar K, El-Serag HB, Mattek N, Gilger MA. Complications of pediatric EGD: a 4-year experience in PEDS-CORI. Gastrointest Endosc. 2007 Feb;65(2):213-21. doi: 10.1016/j.gie.2006.03.015.'}, {'pmid': '11756910', 'type': 'BACKGROUND', 'citation': 'Kaddu R, Bhattacharya D, Metriyakool K, Thomas R, Tolia V. Propofol compared with general anesthesia for pediatric GI endoscopy: is propofol better? Gastrointest Endosc. 2002 Jan;55(1):27-32. doi: 10.1067/mge.2002.120386.'}, {'type': 'BACKGROUND', 'citation': 'U.S Food and Drug Administration. Med Watch. The FDA Safety Information and AdverseReportingProgram.Availableat:http://www.fda.gov/medWatch/report/DESK/advevnt.htm'}, {'pmid': '26184697', 'type': 'RESULT', 'citation': 'Patino M, Glynn S, Soberano M, Putnam P, Hossain MM, Hoffmann C, Samuels P, Kibelbek MJ, Gunter J. Comparison of different anesthesia techniques during esophagogastroduedenoscopy in children: a randomized trial. Paediatr Anaesth. 2015 Oct;25(10):1013-9. doi: 10.1111/pan.12717. Epub 2015 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy.', 'detailedDescription': "Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC) for delivering anesthesia during an esophagogastroduodenoscopy (EGD). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience. One anesthetic technique involves the use of general anesthesia with the placement of an endotracheal tube, and maintenance with an inhalation agent, such as sevoflurane (IS). These patients may be extubated under deep anesthesia in the operating room, and allowed to awaken in the post anesthesia care unit. A similar technique involves the placement of an endotracheal tube, and anesthetic maintenance with a continuous infusion of propofol (IP). These patients are also extubated under deep anesthesia in the operating room, and allowed to awaken in the postoperative care unit. The third technique does not use an endotracheal tube and anesthetic maintenance occurs with continuous infusion of propofol with the patient breathing oxygen through their natural airway (NA). Our objective in this study is to compare outcomes between these three established anesthetic techniques.\n\nChildren in the study will be recruited from Cincinnati Children's Hospital Medical Center Operating Room Schedule. They will be cared for in the Operating Rooms and Post Anesthesia Care Unit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient presenting as out-patients, scheduled to receive an anesthetic for a diagnostic EGD\n* Patient must be a candidate for any of the three anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology, who is not a member of the study team and will be responsible for obtaining consent for anesthesia\n* Patient must be between ages 1 and 12 years (inclusive)\n* Patient must be American Society of Anesthesiology (ASA) class I or II;\n* Eosinophilic esophagitis (EE) patients classified as an ASA III status for their EE diagnosis only\n* Patient must have fasted according to CCHMC policy\n* Patient's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate\n\nExclusion Criteria:\n\n* Patients less than a year old and greater than 12 years old\n* Patients undergoing therapeutic upper endoscopy\n* Patients with an ASA physical status III or greater (other than EE patients)\n* Patients with history of allergy to propofol, any other drug in the protocol, or eggs (exclusive of egg allergies identified only by skin testing or manifested only by gastrointestinal symptoms)\n* Patients with personal or family history of malignant hyperthermia\n* Obese patients (Body mass index more than 95th percentile for age)\n* Patients with significant airway abnormalities (e.g., trisomy 21, craniofacial syndromes, sub-glottic stenosis, tracheomalacia, tracheostomy)\n* Patients with history of obstructive sleep apnea\n* Patient receiving sedative premedication\n* Patient previously treated under this protocol\n* Patients with symptoms of an active upper respiratory infection\n* Patients with history of coagulopathy\n* Patients with esophageal varices or gastrointestinal bleeding"}, 'identificationModule': {'nctId': 'NCT02038894', 'briefTitle': 'Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies', 'orgStudyIdInfo': {'id': '2009-0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intubated with Sevoflurane (IS)', 'description': 'Anesthetic technique during (EGD)', 'interventionNames': ['Drug: Intubated with Sevoflurane (IS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intubated with Propofol (IP)', 'description': 'Anesthetic technique during (EGD)', 'interventionNames': ['Drug: Intubated with Propofol (IP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Native Airway - no intubation', 'description': 'Anesthetic technique during (EGD)', 'interventionNames': ['Drug: Zofran - no intubation', 'Drug: Propofol']}], 'interventions': [{'name': 'Intubated with Sevoflurane (IS)', 'type': 'DRUG', 'description': 'Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.', 'armGroupLabels': ['Intubated with Sevoflurane (IS)']}, {'name': 'Intubated with Propofol (IP)', 'type': 'DRUG', 'description': 'Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.', 'armGroupLabels': ['Intubated with Propofol (IP)']}, {'name': 'Zofran - no intubation', 'type': 'DRUG', 'description': 'A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.', 'armGroupLabels': ['Native Airway - no intubation']}, {'name': 'Propofol', 'type': 'DRUG', 'armGroupLabels': ['Native Airway - no intubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Mario Patino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Cincinati Children's Hospital Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}