Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT04837495
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arrhythmia', 'timeFrame': 'introperative period', 'description': 'the incidnese of Arrhythmia'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hours postoperatively', 'description': 'Numeric Rating Scale and Visual Analog Scale will be used to evaluate post operative analgesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arrythmia', 'Acute pain'], 'conditions': ['Arrythmia', 'Pain, Acute']}, 'descriptionModule': {'briefSummary': 'During Laparoscopic cholecystectomy, carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis.\n\nCO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery.', 'detailedDescription': 'Laparoscopic surgery is being increasingly recognized for its advantages of minimal invasiveness. mild postoperative pain, short length of hospitalization and rapid recovery and is widely used in general surgery, obstetrics. gynecology and urology. Laparoscopic cholecystectomy (LC) has become the gold standard for surgically treating benign diseases of the gallbladder.\n\nDuring carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis.\n\nCO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 -60 years\n* american society of anesthesiologists status I-II\n* Scheduled for elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* Patients with chronic renal dysfunction.\n* Patients with hypo/hyper-thyroidism.\n* Patients with diseases of the autonomic and central nervous systems.\n* Patients with cardiopulmonary dysfunction.\n* Patients with history of treatment with long-term oral tranquilizers.'}, 'identificationModule': {'nctId': 'NCT04837495', 'briefTitle': 'Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Stellate Ganglion Block Efficacy in Control of Arrhythmia and Cardiovascular Changes in Addition to, Postoperative Analgesia in Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'IRB17101436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stellate Ganglion block group', 'description': 'will include 20 patients: each one will receive 10 ml lidocaine 2% right stellate ganglion block (RSGB) under sonar guidance', 'interventionNames': ['Procedure: right stellate ganglion block']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'will include 20 patients: a control group'}], 'interventions': [{'name': 'right stellate ganglion block', 'type': 'PROCEDURE', 'description': "The skin should be anaesthetised with lidocaine 2%. Using a lateral approach and in-plane imaging, a blunt regional anaesthesia needle should be advanced deep to the carotid sheath towards the longus colli muscle. Following careful aspiration, inject 10 ml lidocaine 2% that will result in expansion of the fascia of the longus colli. Confirmation of the SGB success can be detected by warming of left upper limb and left Horner's syndrome.", 'armGroupLabels': ['Stellate Ganglion block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}