Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-02 @ 11:12 AM
Study NCT ID:
NCT01014728
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2009-11-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intraoperative Bleeding During Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], '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'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rnacleri@surgery.bsd.uchicago.edu', 'phone': '773-702-0080', 'title': 'Dr. Robert Naclerio', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Anesthesia', 'description': 'After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Inhalation Anesthesia', 'description': 'After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Anesthesia', 'description': 'After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.'}, {'id': 'OG001', 'title': 'Inhalation Anesthesia', 'description': 'After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'spread': '59.4', 'groupId': 'OG000'}, {'value': '80.3', 'spread': '70.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.937', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'from the start of surgery to the end of surgery, up to 6 hours', 'description': 'Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.', 'unitOfMeasure': 'mL/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anesthesiologist Numeric Rating Scale (ANRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Anesthesia', 'description': 'After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.'}, {'id': 'OG001', 'title': 'Inhalation Anesthesia', 'description': 'After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.25', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'at the end of surgery (up to 6 hours)', 'description': 'The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were three patients in the inhalation anesthesia group with missing values.'}, {'type': 'SECONDARY', 'title': "Surgeon's Numeric Rating Scale (SNRS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Anesthesia', 'description': 'After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.'}, {'id': 'OG001', 'title': 'Inhalation Anesthesia', 'description': 'After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '7.25', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.461', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'at the end of surgery (up to 6 hours)', 'description': "The surgeon's numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were three patients in the inhalation anesthesia group with missing values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravenous Anesthesia', 'description': 'After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.'}, {'id': 'FG001', 'title': 'Inhalation Anesthesia', 'description': 'After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravenous Anesthesia', 'description': 'After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.'}, {'id': 'BG001', 'title': 'Inhalation Anesthesia', 'description': 'After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '16.9', 'groupId': 'BG000'}, {'value': '43.4', 'spread': '16.6', 'groupId': 'BG001'}, {'value': '42.3', 'spread': '16.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2009-11-13', 'resultsFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-20', 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Blood Loss', 'timeFrame': 'from the start of surgery to the end of surgery, up to 6 hours', 'description': 'Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.'}], 'secondaryOutcomes': [{'measure': 'Anesthesiologist Numeric Rating Scale (ANRS)', 'timeFrame': 'at the end of surgery (up to 6 hours)', 'description': 'The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).'}, {'measure': "Surgeon's Numeric Rating Scale (SNRS)", 'timeFrame': 'at the end of surgery (up to 6 hours)', 'description': "The surgeon's numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the blood loss during sinus surgery looking at two different types of anesthesia: either intravenous anesthesia with propofol or inhalational anesthesia with sevoflurane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patients who are 18 years of age or older,\n* ASA grade 1 (normal otherwise healthy patient),\n* ASA grade 2 (patient with mild systemic disease),\n* patients who have chronic sinusitis with or without nasal polyps.\n\nExclusion Criteria:\n\n* pregnancy,\n* abnormal coagulation panel\n* preoperative use of NSAIDS or ASA medications within 7 days,\n* end-stage renal disease,\n* allergy to any of the used medications,\n* maximal body mass index over 35'}, 'identificationModule': {'nctId': 'NCT01014728', 'briefTitle': 'Intraoperative Bleeding During Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane', 'orgStudyIdInfo': {'id': '09-317A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous anesthesia', 'description': 'Intravenous anesthesia with propofol for endoscopic sinus surgery', 'interventionNames': ['Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inhalation anesthesia', 'description': 'Inhalation anesthesia with sevoflurane for endoscopic sinus surgery', 'interventionNames': ['Drug: sevoflurane']}], 'interventions': [{'name': 'propofol', 'type': 'DRUG', 'description': '100-200mcg/kg/min by infusion', 'armGroupLabels': ['Intravenous anesthesia']}, {'name': 'sevoflurane', 'type': 'DRUG', 'description': '1-3% of sevoflurane (expired)', 'armGroupLabels': ['Inhalation anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Robert M Naclerio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}