Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT00690495
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2008-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of a Modified Propofol Emulsion in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'studies@bbraun.com', 'phone': '+49 5661 71', 'title': 'Study manager', 'phoneExt': '0', 'organization': 'B.Braun Melsungen AG'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Modified Propofol', 'description': 'Modified propofol (Propofol 0.5%)', 'otherNumAtRisk': 50, 'otherNumAffected': 44, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Propofol 1%', 'description': 'Propofol 1%', 'otherNumAtRisk': 50, 'otherNumAffected': 26, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Expression of Pain During Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Propofol', 'description': 'Modified propofol (Propofol 0.5%)'}, {'id': 'OG001', 'title': 'Propofol 1%', 'description': 'Propofol 1%'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during first propofol bolus', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Further Assessment of Injection Pain', 'timeFrame': 'during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modified Propofol', 'description': 'Modified propofol (Propofol 0.5%)'}, {'id': 'FG001', 'title': 'Propofol 1%', 'description': 'Propofol 1%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Primary Endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient in: 07.05.2008 Last patient out: 24.09.2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Modified Propofol', 'description': 'Modified propofol (Propofol 0.5%)'}, {'id': 'BG001', 'title': 'Propofol 1%', 'description': 'Propofol 1%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '55.2', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-02', 'studyFirstSubmitDate': '2008-06-02', 'resultsFirstSubmitDate': '2011-08-17', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-17', 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Expression of Pain During Injection', 'timeFrame': 'during first propofol bolus'}], 'secondaryOutcomes': [{'measure': 'Further Assessment of Injection Pain', 'timeFrame': 'during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Induction', 'Pain'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '22012178', 'type': 'DERIVED', 'citation': 'Soltesz S, Diekmann M, Mitrenga-Theusinger A, Keilen M, Molter GP. Reduced pain on injection with a 0.5% propofol emulsion during induction of anesthesia. Eur J Anaesthesiol. 2012 Mar;29(3):162-3. doi: 10.1097/EJA.0b013e32834cfa7d. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.\n\nStudy hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.', 'detailedDescription': 'Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults, age ≥ 18 years and ≤ 80 years\n* Anesthetic risk classified as ASA I-III\n* Patients undergoing elective surgery under general anesthesia\n* Signed informed consent\n\nExclusion Criteria:\n\n* Simultaneous participation in another trial\n* Known or suspected drug abuse\n* Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication\n* Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics)\n* Patients taking lipid lowering drugs\n* History of decompensated renal failure\n* History of severe hepatic dysfunction, hepatic cirrhosis\n* Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia\n* History of convulsive disorders\n* Decompensated cardiac insufficiency\n* Hypovolemia\n* Increased intracranial pressure\n* Pregnancy (positive ß-HCG test) and lactation\n* Emergency situation\n* Patient who receives parenteral fat emulsion, e.g. intralipid\n* Patients incapable of giving consent personally\n* Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal'}, 'identificationModule': {'nctId': 'NCT00690495', 'briefTitle': 'Use of a Modified Propofol Emulsion in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Prospective, Monocentric Controlled, Randomized, Double-blind Study to Compare the Two Different Propofol Emulsions Regarding Tolerability and Injection Pain During the Induction of Anesthesia in Adults', 'orgStudyIdInfo': {'id': 'HC-G-H-0705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Modified propofol (Propofol 0.5%)', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Propofol 1%', 'interventionNames': ['Drug: Propofol 1%']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Modified propofol'], 'description': 'Propofol (drug), intravenous, induction of anesthesia', 'armGroupLabels': ['1']}, {'name': 'Propofol 1%', 'type': 'DRUG', 'otherNames': ['Propofol-Lipuro 1%'], 'description': 'Propofol (drug), intravenous, induction of anesthesia', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51375', 'city': 'Leverkusen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH', 'geoPoint': {'lat': 51.0303, 'lon': 6.98432}}], 'overallOfficials': [{'name': 'Stefan Soltész, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}