Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT04439058
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2020-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'US machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland) was used'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in heart rate', 'timeFrame': 'change in heart rate from base line', 'description': 'heart rate( bpm )'}, {'measure': 'change in Ejection Fraction', 'timeFrame': 'change in Ejection Fraction from base line', 'description': 'Ejection Fraction(%)'}, {'measure': 'change in blood pressure', 'timeFrame': 'change in blood pressure from base line', 'description': 'MAP, Systemic arterial pressure ( mmHg )'}, {'measure': 'change in cardiac rhythm', 'timeFrame': 'change in cardiac rhythm from base line', 'description': 'incidence of AF or VF(BPM)'}], 'secondaryOutcomes': [{'measure': 'effect of preoperative stellate ganglion block on enhanced recovery after coronary arteries bypass grafting surgery', 'timeFrame': 'change of troponin level from base line', 'description': 'measuring troponin level (ng/ml)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The effects of SGB on the cardiovascular system remain controversial since the cardiac sympathetic nerves pass through the stellate ganglion. SGB is expected to have an ameliorative effect on impaired coronary circulation and cardiac function and thus to be well suited to the treatment of angina pectoris and myocardial infarction', 'detailedDescription': 'investigators chose left SGB being safer with regards conductivity changes when compared to right SGB, in the present study investigators are trying to examine and compare whether coronary reperfusion in patients undergoing coronary artery bypass grafting who were subject to ultrasound guided left Stellate ganglion block (SGB ) performed in the induction of anesthesia could decrease post cardiopulmonary bypass ischemic changes, pulmonary hypertension and right ventricular dysfunction leading to enhanced recovery.\n\nPlace of work: Ain shams university hospitals cardiovascular surgery academy, Cairo, Egypt.\n\nNumber and selection of participants:\n\n40 participants, 20 in each group (2 groups).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIschemic heart disease patients age above 18 years\n\nExclusion Criteria:\n\nallergy to LA, severe COPD'}, 'identificationModule': {'nctId': 'NCT04439058', 'briefTitle': 'Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Preoperative Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery', 'orgStudyIdInfo': {'id': 'FMASU R3 /2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine+lignocaine', 'description': 'will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with10 ml of bupivacaine 0,25%+ 5ml lignocaine 1%(20 patients).\n\nUnder complete aseptic precautions an ultrasound guided left stellate ganglion block (paratracheal technique ) The patient placed in the supine position with the head in the neutral position and slightly extended.\n\nThe US probe placed at the level of the cricoid cartilage. The transverse process of the sixth cervical vertebra identified by its prominent anterior tubercle. Also, the longus colli muscle and its overlying prevertebral fascia anterior to the C6 vertebral body and deep to the carotid artery. skin infiltration with local anesthetic, the needle inserted from lateral to medial using the in-plane technique. The aim was to inject the local anesthetics deep to the prevertebral fascia and above the longus colli', 'interventionNames': ['Other: ultrasound guided left stellate ganglion block']}, {'type': 'OTHER', 'label': 'Normal saline', 'description': 'will receive ultrasound guided left stellate ganglion block just after induction of anesthesia with 15 ml of normal saline (20 patients).\n\nUS machine Mindray M5 (Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shenzhen, China.) with a linear 38-mm high frequency 10-12 MHz transducer), with an imaging depth of 4 cm. A 50-mm short bevel 22-gauge insulated stimulating needle (PAJUNK® GmbH Medizin technologie, Deutschland', 'interventionNames': ['Other: ultrasound guided left stellate ganglion block']}], 'interventions': [{'name': 'ultrasound guided left stellate ganglion block', 'type': 'OTHER', 'description': 'Stellate Ganglion Block (SGB) has several established clinical indications Under complete aseptic precautions an ultrasound guided left stellate ganglion block was performed. (paratracheal technique ) ( ) The patient was placed in the supine position with the head in the neutral position and slightly extended. An initial scanning was done with the ultrasound to identify the structures in this area.\n\nThe US probe was placed at the level of the cricoid cartilage. The transverse process of the sixth cervical vertebra was identified by its prominent anterior tubercle. Also, the longus colli muscle and its overlying prevertebral fascia were sought anterior to the C6 vertebral body and deep to the carotid artery. After skin infiltration with local anesthetic, the needle was inserted from lateral to medial using the in-plane technique. The aim was to inject the local anesthetics deep to the prevertebral fascia and above the longus colli', 'armGroupLabels': ['Bupivacaine+lignocaine', 'Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Wail Abdelaal', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'diaa marzouk, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'wail abdelaal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant professor of anesthesia', 'investigatorFullName': 'wail abdelaal', 'investigatorAffiliation': 'Ain Shams University'}}}}