Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT01579851
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2012-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery After Sugammadex(Propofol vs Sevoflurane)
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-04-17', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with an increase in Bispectral Index after sugammadex injection', 'timeFrame': 'One hour after anesthesia', 'description': 'Increase in Bispectral Index (\\> 20) after sugammadex injection'}, {'measure': 'Number of patients with occurence of clinical signs of awakening after sugammadex injection', 'timeFrame': 'One hour after anesthesia', 'description': 'Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ...'}], 'secondaryOutcomes': [{'measure': 'T4/T1 ratio after sugammadex injection', 'timeFrame': 'One hour after anesthesia', 'description': 'Modification of T4/T1 ratio after sugammadex injection'}, {'measure': 'Number of patients with side effects due to sugammadex injection', 'timeFrame': 'One hour after anesthesia', 'description': 'Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,...'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium\n\nExclusion Criteria:\n\n* Known drug allergy,\n* Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex\n* Difficulty to use Bispectral Index monitor\n* Inability to obtain a proper monitoring of muscle relaxation.'}, 'identificationModule': {'nctId': 'NCT01579851', 'acronym': 'Sugammadex2', 'briefTitle': 'Recovery After Sugammadex(Propofol vs Sevoflurane)', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)', 'orgStudyIdInfo': {'id': '2010/58'}, 'secondaryIdInfos': [{'id': '2010-023943-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol-Remifentanil', 'description': 'Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium', 'interventionNames': ['Drug: Sugammadex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane-Remifentanil', 'description': 'Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium', 'interventionNames': ['Drug: Sugammadex']}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'description': 'sugammadex\n\n* 4 mg/kg : if there is no response to Train of Four stimulations and at least one response to the Post Tetanic Count\n* 2 mg/kg : if there is at least two responses to Train of Four stimulations', 'armGroupLabels': ['Propofol-Remifentanil', 'Sevoflurane-Remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92151', 'city': 'Suresnes', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Morgan Le Guen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}