Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-15 @ 7:24 PM
Study NCT ID:
NCT02063620
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2014-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QT and QTc intervals', 'timeFrame': 'Change QT and QTc intervals from baseline to 60 minutes', 'description': '0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.'}], 'secondaryOutcomes': [{'measure': 'mean arteryel pressure', 'timeFrame': 'Change of mean arteryel pressure from baseline to 60 minutes', 'description': '0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVRA, ketamine, lidocaine, ECG'], 'conditions': ['Qt Interval, Variation in']}, 'descriptionModule': {'briefSummary': 'IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus ketamine.', 'detailedDescription': 'Methods: Patients between 18-60 years, with score of ASA 1-2 and who were undergoing IVRA for short operations on arm and forearm were included. Systolic, diastolic and mean blood pressures, heart rate, SpO2, ECG, adverse effects during the operation were recorded. Double cuffed tourniquet were placed on the extremity to be operated to hinder nerve injuries. Venous blood in the extremity was purged with Esmarch bandage. Proximal cuff was inflated with a pressure 50-100 mmHg higher than systolic blood pressure and the bandage was displaced. Randomly patients were divided into 2 groups. Group 1: %0.5 Lidocaine+Ketamine 0.8 mg/kg; 40 ml. Group 2: %0.5 Lidocaine 40 ml. Anesthetic agent was injected with a rate of 20 ml/min. 20 minutes after injection the distal cuff was inflated and the proximal cuff deflated with a rate of 50 mmHg in every 3 minutes. 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between 18-60 years\n2. ASA 1-2 physical status\n3. Undergoing IVRA for short operations on arm and forearm\n\nExclusion Criteria:\n\n1. Allergy to study drugs,\n2. Serious cardiac diseases,\n3. Respiratory diseases,\n4. Renal failure,\n5. Drug addiction,\n6. Pregnancy,\n7. Liver failure,\n8. Hypertension,\n9. Genetic diseases of musculoskeletal system,\n10. Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.'}, 'identificationModule': {'nctId': 'NCT02063620', 'briefTitle': 'The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA', 'organization': {'class': 'OTHER', 'fullName': 'Duzce University'}, 'officialTitle': 'The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia', 'orgStudyIdInfo': {'id': 'gokceakman'}, 'secondaryIdInfos': [{'id': 'ilknurseker', 'type': 'OTHER', 'domain': 'Duzce University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine HCL', 'description': '%0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine', 'interventionNames': ['Drug: Ketamine HCL']}, {'type': 'NO_INTERVENTION', 'label': 'lidocaine+ serum physiologic', 'description': '% 0.5 lidocaine+ serum physiologic, total 40ml, total 200 mg lidocaine, 30 minute duration, single dose administration,'}], 'interventions': [{'name': 'Ketamine HCL', 'type': 'DRUG', 'otherNames': ['Include brande name: ketalar injectable'], 'description': 'ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely', 'armGroupLabels': ['ketamine HCL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81600', 'city': 'Düzce', 'country': 'Turkey (Türkiye)', 'facility': 'Duzce Univercity Medical Fauculty', 'geoPoint': {'lat': 40.83889, 'lon': 31.16389}}], 'overallOfficials': [{'name': 'Gokce Akman Kose', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duzce University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duzce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Ilknur Suidiye', 'investigatorAffiliation': 'Duzce University'}}}}