Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-31 @ 1:42 PM
Study NCT ID:
NCT02057861
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2014-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reversal of Neuromuscular Blockade in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'targetDuration': '9 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-06', 'studyFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reversal of diabetic patients', 'timeFrame': '24 hours', 'description': 'T2i time was recorded as intubation time and T2d time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was given. When TOF rate reached 0,9 patients were extubated and the time was recorded.'}], 'secondaryOutcomes': [{'measure': 'hemodynamic changes', 'timeFrame': '24 hours', 'description': 'Systolic, diastolic blood pressure and heart rate were recorded in the peroperative period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'neuromuscular blockade', 'sugammadex'], 'conditions': ['Observation of Neuromuscular Block']}, 'descriptionModule': {'briefSummary': 'In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.', 'detailedDescription': 'Aim: In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.\n\nMethods: Included patients were divided into 2 groups: diabetic (n=21) and non-diabetic (n=20). All patients were premedicated. After arrival in the operating room, all patients were monitorised with Datex Ohmeda S/5 Anesthesia Machine and electrocardiography (DII derivation), hemodynamic variables, respiratory rate, and inspiratory sevoflurane concentrations were recorded. Neuromuscular monitoring system was used. Anesthesia was induced with propofol 2 mg/kg and fentanyl 1 mcg/kg. After the loss of eyelid reflex the neuromuscular monitoring system automatically identified supramaximal stimulating currents and after that rocuronium 0,6 mg/kg was given. Train of four (TOF) stimulation with the supramaximal current were applied and by recording of second TOF value (TOF2) the patient was intubated. Anesthesia was maintained with 50% O2 + 50% air and sevoflurane of 1-2 % concentration. TOF stimulation was applied and recorded every 20 seconds. Intraoperatively by return T2 rocuronium 0,15 mg/kg was given. T2i time was recorded as intubation time and T2d time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was given. When TOF rate reached 0,9 patients were extubated and the time was recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients (diabetic and non-diabetic) between 18-65 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients (diabetic and non-diabetic) between 18-65 years with risk of anesthesia I-II,\n* For diabetic group patients with Diabetes mellitus Type 2 over 10 years.\n* For non-diabetic group patients without any glucose metabolism disease\n\nExclusion Criteria:\n\n* myasthenia gravis, myotonic dystrophia, motor neuron diseases\n* diabetic neuropathy and nephropathy\n* hepatic, renal and cardiac diseases'}, 'identificationModule': {'nctId': 'NCT02057861', 'briefTitle': 'Reversal of Neuromuscular Blockade in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Duzce University'}, 'officialTitle': 'The Comparison of Reversal of Neuromuscular Blockade in Diabetic and Non-Diabetic Patients', 'orgStudyIdInfo': {'id': 'ozlemersoy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-diabetic', 'description': 'non-diabetic group; 2 mg/kg sugammadex iv, postoperatively Extubation times were recorded.'}, {'label': 'diabetic', 'description': 'Diabetic group; 2 mg/kg sugammadex iv, postoperatively Extubation times were recorded'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81620', 'city': 'Düzce', 'country': 'Turkey (Türkiye)', 'facility': 'Duzce University', 'geoPoint': {'lat': 40.83889, 'lon': 31.16389}}], 'overallOfficials': [{'name': 'yavuz demiraran, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duzce University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duzce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'yavuz demiraran', 'investigatorAffiliation': 'Duzce University'}}}}