Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-10 @ 2:24 PM
Study NCT ID:
NCT04194151
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2019-12-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Propofol Reduction in Anesthesia Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agosvullo@hotmail.com', 'phone': '+34681054151', 'title': 'Dr. Paula Agostina VULLO', 'organization': 'Hospital Central de la Defensa Gomez Ulla'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Pediatric population not included. BMI not registrated. Type of surgery not registered.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline until 60 seconds after endotracheal tube positioned', 'description': 'Extreme bradicardia (HR\\<40) Extreme hypotension (SBP \\<60)', 'eventGroups': [{'id': 'EG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '2 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 2, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 3, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vasoactive drug need', 'notes': 'SBP reduction \\>30% or SBP \\< 90mmHg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Systolic Blood Pressure Variation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol'}, {'id': 'OG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol'}, {'id': 'OG002', 'title': '2 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol'}, {'id': 'OG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol'}, {'id': 'OG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol'}, {'id': 'OG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol'}], 'classes': [{'title': 'SBP baseline/pre-intubation', 'categories': [{'measurements': [{'value': '26', 'spread': '16', 'groupId': 'OG000'}, {'value': '23', 'spread': '12', 'groupId': 'OG001'}, {'value': '18', 'spread': '13', 'groupId': 'OG002'}, {'value': '22', 'spread': '11', 'groupId': 'OG003'}, {'value': '18', 'spread': '13', 'groupId': 'OG004'}, {'value': '17', 'spread': '13', 'groupId': 'OG005'}]}]}, {'title': 'SBP baseline/postintubation', 'categories': [{'measurements': [{'value': '11', 'spread': '22', 'groupId': 'OG000'}, {'value': '8', 'spread': '15', 'groupId': 'OG001'}, {'value': '9', 'spread': '19', 'groupId': 'OG002'}, {'value': '14', 'spread': '18', 'groupId': 'OG003'}, {'value': '16', 'spread': '19', 'groupId': 'OG004'}, {'value': '8', 'spread': '16', 'groupId': 'OG005'}]}]}, {'title': 'SBP pre-intubation/postintubation', 'categories': [{'measurements': [{'value': '-22', 'spread': '27', 'groupId': 'OG000'}, {'value': '-21', 'spread': '28', 'groupId': 'OG001'}, {'value': '-12', 'spread': '17', 'groupId': 'OG002'}, {'value': '-12', 'spread': '21', 'groupId': 'OG003'}, {'value': '-3', 'spread': '16', 'groupId': 'OG004'}, {'value': '-12', 'spread': '16', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned', 'description': 'Non-invasive systolic blood pressure change (%) at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.', 'unitOfMeasure': 'percentage of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Heart Rate Variation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol'}, {'id': 'OG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol'}, {'id': 'OG002', 'title': '2 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol'}, {'id': 'OG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol'}, {'id': 'OG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol'}, {'id': 'OG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol'}], 'classes': [{'title': 'HR baseline/pre-intubation', 'categories': [{'measurements': [{'value': '6', 'spread': '13', 'groupId': 'OG000'}, {'value': '4', 'spread': '8', 'groupId': 'OG001'}, {'value': '4', 'spread': '10', 'groupId': 'OG002'}, {'value': '1', 'spread': '11', 'groupId': 'OG003'}, {'value': '4', 'spread': '15', 'groupId': 'OG004'}, {'value': '5', 'spread': '14', 'groupId': 'OG005'}]}]}, {'title': 'HR baseline/postintubation', 'categories': [{'measurements': [{'value': '-10', 'spread': '19', 'groupId': 'OG000'}, {'value': '-8', 'spread': '15', 'groupId': 'OG001'}, {'value': '-9', 'spread': '16', 'groupId': 'OG002'}, {'value': '-4', 'spread': '17', 'groupId': 'OG003'}, {'value': '-5', 'spread': '20', 'groupId': 'OG004'}, {'value': '-10', 'spread': '18', 'groupId': 'OG005'}]}]}, {'title': 'HR pre-intubation/postintubation', 'categories': [{'measurements': [{'value': '-17', 'spread': '19', 'groupId': 'OG000'}, {'value': '-12', 'spread': '16', 'groupId': 'OG001'}, {'value': '-15', 'spread': '20', 'groupId': 'OG002'}, {'value': '-5', 'spread': '16', 'groupId': 'OG003'}, {'value': '-10', 'spread': '19', 'groupId': 'OG004'}, {'value': '-17', 'spread': '19', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned', 'description': 'Heart rate change (%) registered at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in HR between the studied moments. Negative results mean percentage increase in HR between the studied moments.', 'unitOfMeasure': 'percentage of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure Variation in Elderly (>55y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol'}, {'id': 'OG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol'}, {'id': 'OG002', 'title': '2 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol'}, {'id': 'OG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol'}, {'id': 'OG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol'}, {'id': 'OG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol'}], 'classes': [{'title': 'SBP baseline/pre-intubation', 'categories': [{'measurements': [{'value': '36', 'spread': '12', 'groupId': 'OG000'}, {'value': '26', 'spread': '12', 'groupId': 'OG001'}, {'value': '21', 'spread': '13', 'groupId': 'OG002'}, {'value': '29', 'spread': '6', 'groupId': 'OG003'}, {'value': '21', 'spread': '13', 'groupId': 'OG004'}, {'value': '22', 'spread': '13', 'groupId': 'OG005'}]}]}, {'title': 'SBP baseline/postintubation', 'categories': [{'measurements': [{'value': '19', 'spread': '22', 'groupId': 'OG000'}, {'value': '10', 'spread': '14', 'groupId': 'OG001'}, {'value': '13', 'spread': '19', 'groupId': 'OG002'}, {'value': '22', 'spread': '15', 'groupId': 'OG003'}, {'value': '22', 'spread': '17', 'groupId': 'OG004'}, {'value': '12', 'spread': '13', 'groupId': 'OG005'}]}]}, {'title': 'SBP pre-intubation/postintubation', 'categories': [{'measurements': [{'value': '-27', 'spread': '32', 'groupId': 'OG000'}, {'value': '-23', 'spread': '30', 'groupId': 'OG001'}, {'value': '-10', 'spread': '16', 'groupId': 'OG002'}, {'value': '-10', 'spread': '23', 'groupId': 'OG003'}, {'value': '2', 'spread': '13', 'groupId': 'OG004'}, {'value': '-15', 'spread': '19', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned', 'description': 'Non-invasive SBP change (%) in patients \\> 55 years at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.', 'unitOfMeasure': 'percentage of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Hypnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol'}, {'id': 'OG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol'}, {'id': 'OG002', 'title': '2 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol'}, {'id': 'OG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol'}, {'id': 'OG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol'}, {'id': 'OG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '29', 'groupId': 'OG000'}, {'value': '49', 'spread': '27', 'groupId': 'OG001'}, {'value': '62', 'spread': '34', 'groupId': 'OG002'}, {'value': '41', 'spread': '20', 'groupId': 'OG003'}, {'value': '47', 'spread': '15', 'groupId': 'OG004'}, {'value': '67', 'spread': '42', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After administration of propofol, time is measured in seconds until BIS values are less than 60', 'description': 'Bispectral index (BIS)\\<60 meaning "general anesthesia", BIS\\>60 meaning mild/moderate sedation. We measure the time until patient reachs hypnosis', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Needed Vasoactive Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol'}, {'id': 'OG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol'}, {'id': 'OG002', 'title': '2 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol'}, {'id': 'OG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol'}, {'id': 'OG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol'}, {'id': 'OG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 minute after intubation', 'description': 'Patients who suffered SPB reduction \\> 30% or SPB \\< 90mmHg, receive vasoactive drugs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol'}, {'id': 'FG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol'}, {'id': 'FG002', 'title': '2 Minutes - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol'}, {'id': 'FG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol'}, {'id': 'FG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol'}, {'id': 'FG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Monitorization problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Every patient who agreed to participate and required general anesthesia with endotracheal intubation by the same anesthesiologist', 'preAssignmentDetails': 'Randomization was prior to data collection. The patient number was assigned by computerized randomizer to the 6 study groups. The collection was systematic from day one of the study, including all patients who met inclusion criteria and accepted participation.\n\nOf 192 patients enrolled, 186 met inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '2 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol'}, {'id': 'BG001', 'title': '2 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol'}, {'id': 'BG002', 'title': '2 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol'}, {'id': 'BG003', 'title': '1 Minute - 2 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol'}, {'id': 'BG004', 'title': '1 Minute - 1,5 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol'}, {'id': 'BG005', 'title': '1 Minute - 1 mg/kg Group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '59', 'spread': '20', 'groupId': 'BG000'}, {'value': '61', 'spread': '17', 'groupId': 'BG001'}, {'value': '60', 'spread': '19', 'groupId': 'BG002'}, {'value': '59', 'spread': '17', 'groupId': 'BG003'}, {'value': '64', 'spread': '18', 'groupId': 'BG004'}, {'value': '55', 'spread': '16', 'groupId': 'BG005'}, {'value': '60', 'spread': '18', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '95', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '91', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '73', 'spread': '16', 'groupId': 'BG000'}, {'value': '77', 'spread': '17', 'groupId': 'BG001'}, {'value': '70', 'spread': '15', 'groupId': 'BG002'}, {'value': '71', 'spread': '15', 'groupId': 'BG003'}, {'value': '71', 'spread': '15', 'groupId': 'BG004'}, {'value': '73', 'spread': '15', 'groupId': 'BG005'}, {'value': '72', 'spread': '15', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'anesthesia risk (ASA), categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Low risk', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '111', 'groupId': 'BG006'}]}, {'title': 'High risk', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Low risk: ASA I-II High risk: ASA III-IV', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '81', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Antihypertensive treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '63', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart rate treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'B-Blockers or Calcium antagonists', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-24', 'size': 102283, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-20T14:34', 'hasProtocol': False}, {'date': '2020-07-27', 'size': 167817, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-11T03:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'aleatory assignation, time measured by nurses, drugs administrated by principal investigator'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 time groups, divided into 3 dose groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2019-12-09', 'resultsFirstSubmitDate': '2020-02-23', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-11', 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure Variation', 'timeFrame': 'Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned', 'description': 'Non-invasive systolic blood pressure change (%) at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.'}, {'measure': 'Heart Rate Variation', 'timeFrame': 'Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned', 'description': 'Heart rate change (%) registered at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in HR between the studied moments. Negative results mean percentage increase in HR between the studied moments.'}, {'measure': 'Systolic Blood Pressure Variation in Elderly (>55y)', 'timeFrame': 'Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned', 'description': 'Non-invasive SBP change (%) in patients \\> 55 years at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.'}], 'secondaryOutcomes': [{'measure': 'Time to Hypnosis', 'timeFrame': 'After administration of propofol, time is measured in seconds until BIS values are less than 60', 'description': 'Bispectral index (BIS)\\<60 meaning "general anesthesia", BIS\\>60 meaning mild/moderate sedation. We measure the time until patient reachs hypnosis'}, {'measure': 'Number of Patients Who Needed Vasoactive Drug', 'timeFrame': '1 minute after intubation', 'description': 'Patients who suffered SPB reduction \\> 30% or SPB \\< 90mmHg, receive vasoactive drugs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['propofol synergy', 'fentanyl', 'anesthesia induction'], 'conditions': ['Propofol Adverse Reaction', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Objective: Determine if, by reducing the dose of propofol and increasing the time elapsed between fentanyl and propofol administration, hemodynamic response is improved.\n\nMethods: Patients were randomized into time groups (2 and 1 minute) and each subdivided into dose groups (1, 1.5 and 2 mg kg-1) obtaining six time-dose groups. After receiving 2 μg kg-1 of fentanyl, propofol was administered after the predetermined time. Time to hypnosis (BIS\\<60) and hemodynamic parameters at pre-induction, pre-intubation and postintubation were registered.', 'detailedDescription': 'A minimum of 162 patients were required, considering an expected Mean Difference of 5 with expected Standard Deviation of 22, confidence level of 95% and power of 80%. Estimating a possible loss of 15%, it was raised to 192. Consecutive identification numbers were assigned and the sample was randomized in six groups of 32 patients according to time and dose of propofol.\n\nPre-oxygenation was performed until the expired oxygen fraction exceeded 80% and 2 µg/kg of intravenous fentanyl were administered. Depending on the study group, 1 or 2 minutes were allowed to pass and 1, 1.5 or 2 mg/kg of propofol were supplied (prior administration of intravenous lidocaine 0.5 mg/kg). The time in which the BIS dropped below 60 was recorded. If it did not reach that level after two minutes or when it exceeded it but then rose above 60 again, an extra dose of propofol of 0.5 mg/kg was administered. Muscle relaxation was performed with rocuronium 0.6 mg/kg. The patient was manually ventilated until endotracheal intubation was performed by the same experienced anaesthesiologist and connected to mechanical ventilation.\n\nData were collected manually. Statistical analysis was performed using SPSS ver. 22. Inferential statistics were performed using t-test for quantitative variables, chi-square for qualitative and ANOVA for qualitative and quantitative comparisons. Non-parametric statistical tests were used when necessary. Confidence intervals were estimated at a level of 95% and a P value of \\<.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who required general anesthesia\n* General anesthesia with endotracheal intubation (no supraglottic devices)\n* Signed informed consent\n* Non-cardiac surgery\n* Same anesthesiologist\n\nExclusion Criteria:\n\n* Hemodynamic instability (systolic BP \\< 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis \\<0.5 ml/kg/h, central venous saturation \\<60% with normal arterial saturation or lactate \\>3 mmol/l)\n* Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)\n* Suspected difficult airway\n* Known allergy to anesthetic drugs'}, 'identificationModule': {'nctId': 'NCT04194151', 'briefTitle': 'Impact of Propofol Reduction in Anesthesia Induction', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Central de la Defensa Gómez Ulla'}, 'officialTitle': 'Impact of Propofol Dose Reduction in Relation to the Time Since Administration of Fentanyl During Anesthesia Induction', 'orgStudyIdInfo': {'id': '09/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2 minute - 2 mg/kg group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol', 'interventionNames': ['Drug: Propofol Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 minute - 1,5 mg/kg group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol', 'interventionNames': ['Drug: Propofol Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 minute - 1 mg/kg group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol', 'interventionNames': ['Drug: Propofol Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1 minute - 2 mg/kg group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol', 'interventionNames': ['Drug: Propofol Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1 minute - 1,5 mg/kg group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol', 'interventionNames': ['Drug: Propofol Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1 minute - 1 mg/kg group', 'description': '2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol', 'interventionNames': ['Drug: Propofol Injection']}], 'interventions': [{'name': 'Propofol Injection', 'type': 'DRUG', 'description': '1, 1.5 or 2 mg/kg of propofol according to the subgroup', 'armGroupLabels': ['1 minute - 1 mg/kg group', '1 minute - 1,5 mg/kg group', '1 minute - 2 mg/kg group', '2 minute - 1 mg/kg group', '2 minute - 1,5 mg/kg group', '2 minute - 2 mg/kg group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28047', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital central de la defensa Gomez Ulla', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Paula A Vullo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Central de la Defensa Gómez Ulla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'paula agostina vullo', 'investigatorAffiliation': 'Hospital Central de la Defensa Gómez Ulla'}}}}