Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-04-12 @ 11:08 PM
Study NCT ID:
NCT03043157
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2017-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rocuronium Effective Dose for Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participant receives hypnotic (propofol) before we use the drug'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "Dose-finding using Dixon's up-and-down adaptative clinical trial"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excellent laparoscopic conditions', 'timeFrame': '30 minutes', 'description': 'Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Relaxation']}, 'descriptionModule': {'briefSummary': "This is an adaptative study where each participant's rocuronium dose will depend on the previous patient's response, being higher if it was not enough and lower if it was more than enough.", 'detailedDescription': "Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax abdominal wall for laparoscopic surgery.\n\nRocuronium intubation dose can be enough for intubation but not last enough for excellent laparoscopic conditions. There is little variation in time from anesthesia induction to the end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help providing excellent conditions and fast track extubation.\n\nDixon's up-and-down method will guide this dose-finding study for the ED50."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* general anesthesia\n\nExclusion Criteria:\n\n* deny participation'}, 'identificationModule': {'nctId': 'NCT03043157', 'briefTitle': 'Rocuronium Effective Dose for Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia University Hospital'}, 'officialTitle': 'Rocuronium ED50 for Excellent Laparoscopic Conditions for Cholecistectomy: Dose-finding Adaptative Clinical Trial', 'orgStudyIdInfo': {'id': 'CAAE 60322116.2.0000.0025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dose-finding group', 'description': "The first patient will receive rocuronium 0,6mg/kg. After that, every patient's dose will depend on the outcome of the previous patient. It will go up 0,1mg/kg if the laparoscopic conditions were not excellent or go down 0,1mg/kg otherwise.", 'interventionNames': ['Drug: rocuronium']}], 'interventions': [{'name': 'rocuronium', 'type': 'DRUG', 'description': 'intravenous rocuronium infusion', 'armGroupLabels': ['Dose-finding group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000000', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital das Forças armadas', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Gabriel MN Guimaraes, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade de Brasilia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology', 'investigatorFullName': 'Gabriel Magalhaes Nunes Guimaraes', 'investigatorAffiliation': 'Brasilia University Hospital'}}}}