Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-02 @ 4:51 AM
Study NCT ID:
NCT05102058
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium and Dexmedetomidine in Pheochromocytoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010673', 'term': 'Pheochromocytoma'}], 'ancestors': [{'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sodium nitroprusside (SNP) requirement', 'timeFrame': 'intraoperative period', 'description': 'intraoperative hypertensive episodes requiring SNP therapy'}], 'secondaryOutcomes': [{'measure': 'vasoactive therapy', 'timeFrame': 'intraoperative period', 'description': 'hemodynamic fluctuations (hypotension, tachycardia, severe hypertensive crisis) which needed vasoactive therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnesium', 'Dexmedetomidine', 'Nitroprusside', 'Pheochromocytoma'], 'conditions': ['Phaeochromocytoma Crisis', 'Hemodynamic Instability']}, 'descriptionModule': {'briefSummary': 'Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients' data who were aged 18-75, had the American Society of Anesthesiologists classification (ASA) 1-3 and high urinary catecholamine or metabolites. Patients with tumor sizes \\< 5 cm and body mass index (BMI) \\<35 kg.m-2 were examined, who were evaluated according to Endocrine Society Practice Guideline and provided the Roizen criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists classification (ASA) 1-3\n* high urinary catecholamine or metabolites\n* tumor sizes \\< 5 cm\n* body mass index (BMI) \\<35 kg/m2\n\nExclusion Criteria:\n\n* open surgery\n* bilateral masses\n* tumor larger than 5 cm\n* incomplete data'}, 'identificationModule': {'nctId': 'NCT05102058', 'briefTitle': 'Magnesium and Dexmedetomidine in Pheochromocytoma', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Magnesium and Dexmedetomidine Combination Reduces Sodium Nitroprusside Requirement in Laparoscopic Pheochromocytoma', 'orgStudyIdInfo': {'id': '2021/42'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional group (GC)', 'description': 'Not receive perioperative additional medication.'}, {'label': 'Magnesium-dexmedetomidine therapy group (GMD)', 'description': 'Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively.', 'interventionNames': ['Drug: Magnesium-Dexmedetomidine']}], 'interventions': [{'name': 'Magnesium-Dexmedetomidine', 'type': 'DRUG', 'description': 'Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively', 'armGroupLabels': ['Magnesium-dexmedetomidine therapy group (GMD)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nükhet Sivrikoz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attending anesthesiologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Anesthesiologist', 'investigatorFullName': 'Nukhet Sivrikoz', 'investigatorAffiliation': 'Istanbul University'}}}}