Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 8:51 AM
Study NCT ID:
NCT01161004
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2010-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2010-07-09', 'studyFirstSubmitQcDate': '2010-07-12', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modification of bispectral and neurosenses indices following sugammadex injection', 'timeFrame': 'day 1 after anesthesia'}], 'secondaryOutcomes': [{'measure': 'efficacy of sugammadex to reverse myorelaxation', 'timeFrame': 'day 1 after anesthesia'}, {'measure': 'clinical signs of recovery after sugammadex injection', 'timeFrame': 'day 1 after anesthesia'}, {'measure': 'residual myorelaxation in the post-anesthesia care unit', 'timeFrame': 'day 1 after anesthesia'}, {'measure': 'score of White and Song during the three first postoperative hours', 'timeFrame': 'day 1 after anesthesia'}, {'measure': 'duration of stay in the postanesthesia care unit', 'timeFrame': 'day 1 after anesthesia'}, {'measure': 'occurence of explicit memorisation', 'timeFrame': 'day 1 after anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '15778268', 'type': 'BACKGROUND', 'citation': 'Vasella FC, Frascarolo P, Spahn DR, Magnusson L. Antagonism of neuromuscular blockade but not muscle relaxation affects depth of anaesthesia. Br J Anaesth. 2005 Jun;94(6):742-7. doi: 10.1093/bja/aei120. Epub 2005 Mar 18.'}, {'pmid': '31808151', 'type': 'DERIVED', 'citation': 'Le Guen M, Roussel C, Chazot T, Dumont GA, Liu N, Fischler M. Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index. Anaesthesia. 2020 May;75(5):583-590. doi: 10.1111/anae.14897. Epub 2019 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'It has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1) affects depth of anaesthesia with an increase in bispectral index (mean maximal change of 7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7).\n\nSugammadex has a quicker and more complete effect than neostigmine. This study aims to demonstrate if sugammadex administration increases bispectral and neurosense indices of the depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled to receive general anesthesia with muscle relaxation\n\nExclusion Criteria:\n\n* contra-indication to the administration of propofol, remifentanil, rocuronium and to the use of the Bispectral Index or NeuroSense monitor\n* known drug allergy or hypersensitivity to a drug used in the study\n* history of central brain injury\n* patient treated with a psychotropic agent\n* patient with a pacemaker\n* severe renal insufficiency\n* treatment by toremifene, flucloxacillin or fusidic acid in the preoperative or immediate postoperative period'}, 'identificationModule': {'nctId': 'NCT01161004', 'acronym': 'Sugarecovery', 'briefTitle': 'Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Pilot Study of EEG Signs of Awakening Secondary to Injection of Sugammadex: Evaluation by Recording Bispectral Index and NeuroSENSE (Prospective, Double-blind Study)', 'orgStudyIdInfo': {'id': '2010/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex - Nacl 9/00', 'description': 'Sugammadex - Nacl 9/00:\n\nPatients will first receive sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.\n\nIn case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake.\n\nIn the adverse case, patients wil receive Nacl 9/00 5 minutes after the first bolus of sugammadex.\n\nThe study is finished 5 minutes after this second injection and care is let to the choice of the anesthesiologist in charge.', 'interventionNames': ['Drug: Sugammadex - Nacl 9/00']}, {'type': 'EXPERIMENTAL', 'label': 'Nacl 9/00 - sugammadex', 'description': 'Nacl 9/00 - Sugammadex :\n\nPatients wil first receive Nacl 9/00. In case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake.\n\nIn the adverse case, patients wil receive sugammadex 5 minutes after the first bolus of Nacl 9/00.\n\nSugammadex is given as: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.\n\nThe study is finished 5 minutes after the injection of sugammadex and care is let to the choice of the anesthesiologist in charge.', 'interventionNames': ['Drug: Nacl 9/00 - sugammadex']}], 'interventions': [{'name': 'Sugammadex - Nacl 9/00', 'type': 'DRUG', 'otherNames': ['Sugammadex: Bridion'], 'description': '* Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.\n* Nacl 9/00: same volume as Sugammadex', 'armGroupLabels': ['Sugammadex - Nacl 9/00']}, {'name': 'Nacl 9/00 - sugammadex', 'type': 'DRUG', 'otherNames': ['Sugammadex: Bridion'], 'description': '* Nacl 9/00: same volume as Sugammadex\n* Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.', 'armGroupLabels': ['Nacl 9/00 - sugammadex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}