Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT06981494
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2024-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537466', 'term': 'Microphthalmia, syndromic 7'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of hemodynmaic stability', 'timeFrame': '6 months', 'description': 'Assess Hemodynamic Stability: Compare the hemodynamic stability provided by dexmedetomidine and ketodex, focusing on parameters such as blood pressure and heart rate will be monitored every 5 minutes and we will record the average every 20 minutes intraoperative . This monitoring will help assess the stability of each patient and the safety profile of the anesthetic agents used in the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.\n\n\\- Assessment the analgesic and sedative role of both drugs.', 'detailedDescription': 'Comparison regarding the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.\n\n* comparison between both drugs in recovery and hemodynamics stability\n* Assessment the analgesic and sedative role of both drugs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Age Range: Patients aged 18-60 years who are scheduled for elective Ear and nose surgeries requiring controlled hypotensive anesthesia.\n* ASA Classification: Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.\n* Surgical Procedures: Individuals undergoing specific ear and nose surgeries where controlled hypotensive anesthesia is typically indicated.\n* Stable Cardiovascular Health: Patients with stable cardiovascular function, without significant history of uncontrolled hypertension , hypotension or ischaemic heart diseases.\n\nExclusion Criteria\n\n* Severe Cardiovascular Conditions: Patients with severe cardiovascular diseases such as congestive heart failure, uncontrolled hypertension , arrhythmias or ischaemic heart diseases .\n* Any cardiac patients.\n* Respiratory Conditions: Individuals with significant respiratory conditions like chronic obstructive pulmonary disease (COPD) or severe asthma.\n* Drug Allergies: Patients with known hypersensitivity or allergic reactions to dexmedetomidine, ketamine or any other components of the study drugs.\n* Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks to the fetus or infant.\n* Chronic Medication Use: Patients on chronic medications that could interfere with blood pressure regulation or interact with the study drugs (e.g., beta-blockers, MAO inhibitors).\n* Patients with chronic liver or renal diseases.\n* Psychiatric or Neurological Disorders: Individuals with severe psychiatric or neurological disorders that could impact the study outcomes or the patient's ability to consent.\n* Substance Abuse: Patients with a history of substance abuse, particularly involving sedatives or opioids, which could affect anesthesia requirements or recovery.\n* Coagulation Disorders: Individuals with coagulation disorders or on anticoagulant therapy, due to the increased risk of bleeding."}, 'identificationModule': {'nctId': 'NCT06981494', 'briefTitle': 'Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) Regarding Hemodynamics Stability, Recovery and Postoperative Pain in Ear and Nose Surgeries, A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Soh-Med--25-4-02MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine Group (D)', 'description': "Dexmedetomidine Group (D) :\n\nWe give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine\n\nLoading Dose:\n\nDexmedetomidine is usually administered as a loading dose of 0.5 mcg/kg slowly.\n\nMaintenance Dose:\n\nAfter the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response.", 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):', 'description': 'Ketamine Component:\n\nWe give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine and ketamine\n\nLoading Dose:\n\nKetamine is typically given at a dose of 0.5 mg/kg as a bolus injection.\n\nMaintenance Dose:\n\nA maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump.\n\nDexmedetomidine Component:\n\nLoading Dose:\n\nAs with the dexmedetomidine group, a loading dose of 0.5 mcg/kg slowly is administered.\n\nMaintenance Dose:\n\nThe maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump.', 'interventionNames': ['Drug: Dexmedetomidine and ketamine ( Ketodex )']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': "Loading Dose:\n\nDexmedetomidine is usually administered as a loading dose of 0.25 mcg/kg slowly.\n\nMaintenance Dose:\n\nAfter the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response.", 'armGroupLabels': ['Dexmedetomidine Group (D)']}, {'name': 'Dexmedetomidine and ketamine ( Ketodex )', 'type': 'DRUG', 'description': 'Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):\n\nKetamine Component:\n\nLoading Dose:\n\nKetamine is typically given at a dose of 0.5 mg/kg as a bolus injection.\n\nMaintenance Dose:\n\nA maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump.\n\nDexmedetomidine Component:\n\nLoading Dose:\n\nAs with the dexmedetomidine group, a loading dose of 0.25 mcg/kg slowly is administered.\n\nMaintenance Dose:\n\nThe maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump.', 'armGroupLabels': ['Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin', 'role': 'CONTACT', 'email': 'Portal@med.sohag.edu.eg', 'phone': '0934602963'}], 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia resident', 'investigatorFullName': 'Madonna Samir Sobhy', 'investigatorAffiliation': 'Sohag University'}}}}