Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT04953156
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2021-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-08', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood pressure values', 'timeFrame': 'Intraoperative period', 'description': 'measurements of blood pressure'}], 'secondaryOutcomes': [{'measure': 'Intraoperative heart rate values', 'timeFrame': 'operative time', 'description': 'measurements of intraoperative heart rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.', 'detailedDescription': 'Nitroglycerine is a direct vessel wall vasodilator with more venodilator effect than arterial dilator effect. It is used as an anti-anginal and antihypertensive drug. On the other hand, dexmedetomidine is a highly selective alpha 2 adrenergic agonist with sympatholytic effect. This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia\n* ≥ Age 18 years.\n\nExclusion Criteria:\n\n* patient refusal\n* patients on Beta blockers\n* kidney or liver function impairment\n* bradycardia, any degree of heart block and severe cardiorespiratory disease'}, 'identificationModule': {'nctId': 'NCT04953156', 'briefTitle': 'Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'A Comparative Study Between Nitroglycerine Infusion and Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension', 'orgStudyIdInfo': {'id': 'AP2105-50107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nitroglycerin', 'description': 'data of patients meeting the eligibility criteria and received nitroglycerine infusion will be retrieved from medical records.', 'interventionNames': ['Drug: Nitroglycerin']}, {'label': 'Dexmedetomidine', 'description': 'patients will receive dexmedetomidine bolus dose of 1 mic/kg over 20 minutes followed by intravenous infusion of 0.2-0.7 mic/kg/hr adjusted according to each patient hemodynamic response', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Nitroglycerin', 'type': 'DRUG', 'description': 'data will be retrieved from intraoperative medical records for the period from May 2020 to May 2021 for patients meeting the eligibility criteria who developed uncontrolled elevation of their blood pressure and received nitroglycerine infusion', 'armGroupLabels': ['Nitroglycerin']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'All patients who develop uncontrolled elevation of their blood pressure and meeting the eligibility criteria from July 2021 to July 2022 will receive dexmedetomidine bolus of 1mic/kg over 20 minutes and then continuous infusion of 0.2-0.7 mic/kg/hour adjusted according to each patient hemodynamic response.', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Walaa Y Elsabeeny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data will be available upon reasonable request through contacting the principle investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia and Pain management', 'investigatorFullName': 'Walaa Youssef Elsabeeny', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}