Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-02 @ 7:06 AM
Study NCT ID:
NCT03128151
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing the Incidence of PostOperative Residual Curarization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2314}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of PORC.', 'timeFrame': 'Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.', 'description': 'To reduce the incidence of PORC ≤ 10% by the introduction of an educational program and a bundle of preventive measures (including intraoperative monitoring and reversal of neuromuscular blocking agents (NMBA)).'}], 'secondaryOutcomes': [{'measure': 'Compliance rate with the bundle of measures', 'timeFrame': 'Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.', 'description': 'To evaluate if the educational program increases compliance of clinical preventive measures, if the reduction of incidence of BNMR is maintained, and, in addition, if this compliance is maintained over time.'}, {'measure': 'Rate of intraoperative monitoring', 'timeFrame': 'Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).', 'description': 'Rate of compliance of clinical prevention measures with intraoperative monitoring.'}, {'measure': 'Rate of reversal of NMBA', 'timeFrame': 'Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).', 'description': 'Rate of compliance of clinical prevention measures with NMBA reversal after surgery.'}, {'measure': 'Perception of safety -increase- by anesthesiologists', 'timeFrame': 'Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).', 'description': 'To evaluate, from the point of view of patient safety, whether the perception of safety by clinicians is maintained, through a survey before and after the intervention.'}, {'measure': 'Incidence of postoperative adverse events.', 'timeFrame': 'Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).', 'description': 'Incidence of postoperative complications in relation to the NMB reversal rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NMB (Neuromuscular Blockade)', 'Anesthesia', 'Curarization', 'TOFr (train of four)', 'PACU (postanesthesia care unit)', 'Monitorization'], 'conditions': ['Neuromuscular Blockade']}, 'referencesModule': {'references': [{'pmid': '37087332', 'type': 'DERIVED', 'citation': 'Diaz-Cambronero O, Mazzinari G, Errando CL, Garutti I, Gurumeta AA, Serrano AB, Esteve N, Montanes MV, Neto AS, Hollmann MW, Schultz MJ, Argente Navarro MP; Reducing the Incidence of Post Operative Residual Curarization Zero investigators. An educational intervention to reduce the incidence of postoperative residual curarisation: a cluster randomised crossover trial in patients undergoing general anaesthesia. Br J Anaesth. 2023 Sep;131(3):482-490. doi: 10.1016/j.bja.2023.02.031. Epub 2023 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'The NMB (Neuromuscular Blockade) is the most frequent complication in anesthesiology associated with an increase in adverse respiratory events in the postoperative period. Its appearance depends on multiple factors. The introduction of a comprehensive educational strategy aimed at promoting the proper management of NMB in the intraoperative period and a package of measures that must be performed (intraoperative neuromuscular monitoring and reversal of the effect of neuromuscular blockers) may contribute to a decrease in the incidence of NMB, Increase safety in the surgical patient and decrease associated costs.', 'detailedDescription': 'Multicenter, epidemiological, prospective, randomized, sequential study. The introduction of an educational program and a package of clinical measures (specific monitoring and pharmacological reversion) in the incidence of NMB will be evaluated by evaluating variations in this incidence of NMB, the rate of compliance with the preventive measures and the perception of the Safety in the perioperative, through pre and postoperative survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted to general anesthesia with neuromuscular blockade, extubated before admission to the Post Anesthesia Recovery Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years.\n* Classification of the American Society of Anesthesiologists (ASA I-III).\n* Patients with absence of cognitive deficit.\n* Informed informed consent prior to surgery\n\nExclusion Criteria:\n\n* Negative of the patient to participate in the study\n* Patients under the age of 18 or incapable of giving their consent\n* ASA IV-V\n* Pregnancy or breastfeeding\n* Associated neuromuscular disorders\n* Diabetes mellitus with diagnosed neuropathy'}, 'identificationModule': {'nctId': 'NCT03128151', 'acronym': 'PORCzero', 'briefTitle': 'Reducing the Incidence of PostOperative Residual Curarization', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Fe'}, 'officialTitle': 'PORCzero: PostOperative Residual Curarization', 'orgStudyIdInfo': {'id': 'CEO-SUG-2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Intraoperative neuromuscular monitoring and pharmacological reversion according to data sheet', 'interventionNames': ['Behavioral: Educational program for clinicians: implementation of a package of clinical prevention measures of NMB']}, {'label': 'Control group', 'description': 'Treated according to usual clinical practice'}], 'interventions': [{'name': 'Educational program for clinicians: implementation of a package of clinical prevention measures of NMB', 'type': 'BEHAVIORAL', 'description': 'Intraoperative neuromuscular monitoring and pharmacological reversion of NMB according to data sheet', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Oscar Diaz Cambronero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital La Fe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oscar Diaz-Cambronero', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Investigacion Sanitaria La Fe', 'class': 'OTHER'}, {'name': 'Instituto de Investigacion Sanitaria INCLIVA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician, specialist in Anesthesiology', 'investigatorFullName': 'Oscar Diaz-Cambronero', 'investigatorAffiliation': 'Hospital Universitario La Fe'}}}}