Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT03515694
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimal Optimal Dose of Sugammadex in Elective Surgery
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel, Double blind Monocentric Prospective Vs placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the recovery time of the ratio 0.9.', 'timeFrame': '1 hour', 'description': 'Evaluate the recovery time of the ratio 0.9.'}], 'secondaryOutcomes': [{'measure': 'Time of appearance of 4 responses to the TOF', 'timeFrame': '1 hour', 'description': 'Time of appearance of 4 responses to the TOF'}, {'measure': 'Evaluate the four-to-four ratio <0.7 after total recovery.', 'timeFrame': '1 hour', 'description': 'Evaluate the four-to-four ratio \\<0.7 after total recovery.'}, {'measure': 'Watch time at the recovery room.', 'timeFrame': '4 hours', 'description': 'Watch time at the recovery room.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bridion', 'Sugammadex', 'TOF'], 'conditions': ['Time of a TOF Ratio >0,9']}, 'descriptionModule': {'briefSummary': 'Time of appearance of TOF Ratio \\>0,9 with different doses of Sugammadex', 'detailedDescription': 'Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion criteria: women and men\\> 18 years old, elective surgery, BMI \\<30, patients giving consent to free and informed participation in writing;\n\nExclusion criteria:\n\n* minor patients;\n* Patients refusing to sign the consent;\n* Patients included in another protocol within 3 months;\n* Pregnant or lactating patients;\n* Patients with a history of allergy to Sugammadex;\n* Patients with known neuromuscular disease;\n* Patients with renal or hepatic impairment.\n\nCourse of the study :\n\n* 40 patients will be recruited at the time of the anesthesia consultation and randomized to double blind in 8 groups (the day before surgery)\n* All patients will benefit from general anesthesia. Anesthetic management\n\n (1- 3mg / kg / IV propofol, 0.2 μg / IV sufentanil, 0.6 mg / kg rocuronium and maintenance anesthesia with sevoflurane) will be standardized for all patients.\n* Upon administration of rocuronium the acceleromyography transducer will be attached to the distal phalanx of the thumb, and repeated TOF stimulation will be applied to the ulnar nerve wrist at intervals of 15 seconds. Neuromuscular monitoring is continued until the end of the anesthesia.\n* Once the first answer (1st twitch) appeared a dose of sugammadex will be administered according to the group whose patient was randomized: Test Groups Control Groups Group 1: Placebo + TOF 1 Group 1bis: Placebo + TOF2 Group 2: 0.5 mg / kg + TOF1 Group 2bis: 0.5 mg / kg + TOF2 Group 3: 1mg / kg + TOF1 Group 3bis: 1mg / kg + TOF2 Group 4: 2mg / kg + TOF 1 Group 4bis: 2mg / kg + TOF 2\n* Then a standard dose of 4mg / kg will be administered at the end of the procedure before awakening to all patients who have signs of residual curarization (TOF ratio \\<0.9). The pharmacy will be responsible for preparing the different doses of sugammadex, the syringe will be carefully covered and packaged, will contain an equal volume so that the anesthetists do not know which group the patient belongs to. Data collection: In real time during the intervention by the anesthesiologist in charge of patient Method of Analysis: Analysis of intent-to-treat data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nwomen and men\\> 18 years of age Elective Surgery BMI \\<30, patients who gave consent to free and informed participation in writing\n\nExclusion Criteria:\n\n* minor patients;\n* patients refusing to sign consent;\n* patients included in another protocol within 3 months;\n* pregnant or nursing patients;\n* patients with a history of allergy to Sugammadex;\n* patients with known neuromuscular disease\n* patients with renal or hepatic impairment.'}, 'identificationModule': {'nctId': 'NCT03515694', 'briefTitle': 'Minimal Optimal Dose of Sugammadex in Elective Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Minimal Optimal Dose of Sugammadex in Elective Surgery', 'orgStudyIdInfo': {'id': 'BRIDION_ERASME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Dose of 0mg/kg TOF1', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dose of 0mg/kg TOF2', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}, {'type': 'EXPERIMENTAL', 'label': 'Dose of 0 ,5mg/kg TOF1', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose of 0,5mg/kg TOF2', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}, {'type': 'EXPERIMENTAL', 'label': 'Dose of 1mg/kg TOF1', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose of 1mg/kg TOF2', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}, {'type': 'EXPERIMENTAL', 'label': 'Dose of 2mg/kg TOF1', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose of 2mg/kg TOF2', 'interventionNames': ['Drug: Sugammadex Injection [Bridion]']}], 'interventions': [{'name': 'Sugammadex Injection [Bridion]', 'type': 'DRUG', 'description': 'Injection of 10mL of translucide solution', 'armGroupLabels': ['Dose of 0 ,5mg/kg TOF1', 'Dose of 0,5mg/kg TOF2', 'Dose of 0mg/kg TOF1', 'Dose of 0mg/kg TOF2', 'Dose of 1mg/kg TOF1', 'Dose of 1mg/kg TOF2', 'Dose of 2mg/kg TOF1', 'Dose of 2mg/kg TOF2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Wendy FERNANDEZ, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasme University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}