Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT01301261
Status:
UNKNOWN
Last Update Posted:
2012-06-19
First Post:
2011-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sugammadex: Effect on the Awareness Monitoring and Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2016-03-14', 'unreleaseDateUnknown': True}], 'estimatedResultsFirstSubmitDate': '2016-03-14'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-18', 'studyFirstSubmitDate': '2011-02-22', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Entropy', 'timeFrame': 'every three minutes'}], 'secondaryOutcomes': [{'measure': 'hemodynamics', 'timeFrame': 'every three minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sugammadex', 'entropy', 'bispectral index', 'blood pressure', 'heart rate', 'oxygenation', 'end-tidal CO2', 'hemodynamics', 'general anesthesia'], 'conditions': ['Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': 'Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.', 'detailedDescription': 'Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.\n\nGroup 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.\n\nHeart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients ASA I-III scheduled for elective major surgery\n* both sexes\n\nExclusion Criteria:\n\n* patients hypertensive\n* treated with antihypertensive drugs'}, 'identificationModule': {'nctId': 'NCT01301261', 'briefTitle': 'Sugammadex: Effect on the Awareness Monitoring and Hemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker', 'orgStudyIdInfo': {'id': 'Σ-150/03-08-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sugammadex 2 mg/kg', 'description': '2 mg/kg of sugammadex are given when a response of two counts of train of four are present', 'interventionNames': ['Drug: sugammadex']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 mg/kg of sugammadex', 'description': '4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears', 'interventionNames': ['Drug: Sugammadex 4 mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sugammadex 16 mg/kg', 'description': 'Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium', 'interventionNames': ['Drug: Sugammadex 16mg/kg']}], 'interventions': [{'name': 'sugammadex', 'type': 'DRUG', 'description': 'Sugammadex 2 mg/kg when a two count of train of four appears', 'armGroupLabels': ['sugammadex 2 mg/kg']}, {'name': 'Sugammadex 4 mg/kg', 'type': 'DRUG', 'description': 'Sugammadex 4 mg/kg are given when a posttetanic count 1-3 appears', 'armGroupLabels': ['4 mg/kg of sugammadex']}, {'name': 'Sugammadex 16mg/kg', 'type': 'DRUG', 'description': 'Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium', 'armGroupLabels': ['Sugammadex 16 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Argyro Fassoulaki, MD, PhD, DEAA', 'role': 'CONTACT'}, {'name': 'Konstantinos Chondrogiannis', 'role': 'CONTACT'}], 'facility': 'Department of Anesthesiology, Aretaieio Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Argyro Fassoulaki, MD, PhD, DEAA', 'role': 'CONTACT', 'email': 'fassoula@aretaieio.uoa.gr', 'phone': '+30210 9024530'}, {'name': 'Konstantinos Chondrogiannis, MD', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, DEAA', 'investigatorFullName': 'Argyro Fassoulaki', 'investigatorAffiliation': 'University of Athens'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-03-14', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}], 'unpostedResponsibleParty': 'Argyro Fassoulaki, MD, PhD, DEAA, University of Athens'}}}}