[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644432":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":44,"studyPopulation":34,"armGroups":45,"interventions":57,"overallOfficials":34,"centralContacts":67,"locations":75,"responsibleParty":91,"collaborators":34,"id":95,"slug":34,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":34,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":34,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Sohag University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Mean intaroperative heart rate (beats \u002Fminute) during vasopressor infusion measured by continous electrocardiogrammonitoring","Heart rate will be continously monitored using standar electrocardiogram monitoring. to compare the effect of norepinephrine versus phenylephrine infusion on hemodynamics.","From the start of subarachnoid block until the end of surgery .",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Incidence of spinal anesthesia-induced hypotension","Defined as a decrease in mean arterial pressure (MAP) to \\\u003C80% of baseline measurd by non-invasive blood pressure monitoring .","From the administration of spinal anesthesia until the end of the procedure.",{"measure":19,"description":20,"timeFrame":21},"Incidence of bradycardia","Defined as heart rate ≤ 50 beats\u002Fmin.","Throughout the intraoperative period",{"measure":23,"description":24,"timeFrame":25},"Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring","Monitoring the stability of blood pressure during vasopressor infusion","Every 5 minutes from the start of spinal anesthesia until the end of surgery.",{"measure":27,"description":28,"timeFrame":29},"Incidence of reactive hypertension measured by non-invasive blood pressure monitoring","Defined as mean arterial pressure (MAP) \\> 125% of baseline.","From the start of vasopressor infusion until the end of surgery.",{"measure":31,"description":32,"timeFrame":33},"Total intraoperative intavenous fluid","Total volume of intravenous fluids administered in milliliters","At the end of the surgical procedure.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":40,"maskingDescription":34,"whoMasked":41},"DOUBLE",[42,43],"PARTICIPANT","OUTCOMES_ASSESSOR","Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing orthopedic hip surgery. Age-related physiological changes, impaired autonomic responses, and reduced cardiovascular reserve increase susceptibility to hypotension after subarachnoid block, which may result in organ hypoperfusion, myocardial ischemia, nausea, vomiting, and increased perioperative morbidity.\n\nPhenylephrine is traditionally used for prevention and treatment of spinal anesthesia-induced hypotension because of its potent alpha-adrenergic vasoconstrictive effect. However, its use may be associated with reflex bradycardia and reduction in cardiac output. Norepinephrine, which possesses both alpha-adrenergic and mild beta-adrenergic activity, may provide better maintenance of heart rate and cardiac output while effectively preserving blood pressure.\n\nThis prospective randomized double-blinded clinical trial will be conducted at the Department of Anesthesia, Intensive Care and Pain Management, Sohag University Hospitals, after approval from the Institutional Ethics Committee. Elderly patients aged 60 years or older, classified as ASA physical status I-III and scheduled for elective orthopedic hip surgery under spinal anesthesia, will be enrolled after obtaining written informed consent.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Norepinehrine group","EXPERIMENTAL","• NE group: norepinephrine infusion at 8 µg\u002Fmin. Infusion will continue for 45 minutes after spinal anesthesia.",[51],"Drug: Norepinephrine",{"label":53,"type":48,"description":54,"interventionNames":55},"Phenylepherine group","PhE group: phenylephrine infusion at 100 µg\u002Fmin Infusion will continue for 45 minutes after spinal anesthesia.",[56],"Drug: Phenylephrine",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":34},"DRUG","Norepinephrine","norepinephrine infusion at 8 µg\u002Fmin. Infusion will continue for 45 minutes after spinal anesthesia.",[47],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":34},"Phenylephrine","phenylephrine infusion at 100 µg\u002Fmin. Infusion will continue for 45 minutes after spinal anesthesia.",[53],[68,73],{"name":69,"role":70,"phone":71,"phoneExt":34,"email":72},"Ahmed Abdelhamed Faress, Resident","CONTACT","01065080913","drahmedfaress23896@gmail.com",{"name":74,"role":70,"phone":34,"phoneExt":34,"email":34},"Fawzy Abbas Badawy, Professor",[76],{"facility":77,"status":78,"city":79,"state":34,"zip":34,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Sohag university hospital","RECRUITING","Sohag","Egypt","EG",{"type":83,"coordinates":84},"Point",[85,86],31.69478,26.55695,{"lat":86,"lon":85},[89],{"name":90,"role":70,"phone":34,"phoneExt":34,"email":34},"Mohamed N Hamdoun, Professor",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Ahmed Abdelhameed Fares","Resident of anaesthesia. Surgical ICU and pain managment at sohag university hospital","100644432",false,"NCT07662408","Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension","Comparison of Norepinephrine Versus Phenylephrine Infusion for Prevention of Hypotension Due to Subarachnoid Block in Elderly Patients Undergoing Orthopedic Hip Surgery:A Prospective Randomized Trial","Inclusion Criteria:\n\n1. Age 60 years or older.\n2. ASA physical status I-III.\n3. Scheduled for elective hip surgery under subarachnoid block.\n4. Willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Patient refusal.\n2. Contraindications to subarachnoid block.\n3. Severe cardiac disease.\n4. Uncontrolled hypertension.\n5. Allergy to study drugs.\n6. Emergency surgery.\n7. Monoamine oxidase inhibitor use.\n8. Cognitive impairment preventing informed consent.",true,"ALL","60 Years","100 Years",{"count":106,"type":107},62,"ESTIMATED","INTERVENTIONAL",[110],"PHASE4","This prospective randomized double-blinded clinical trial aims to compare the efficacy and hemodynamic effects of prophylactic norepinephrine infusion versus phenylephrine infusion for prevention of spinal anesthesia-induced hypotension in elderly patients undergoing elective orthopedic hip surgery under subarachnoid block. Sixty-two patients aged 60 years or older will be randomly assigned into two equal groups to receive either norepinephrine infusion (8 µg\u002Fmin) or phenylephrine infusion (100 µg\u002Fmin) immediately after spinal anesthesia. The primary outcome is the mean heart rate during vasopressor infusion, while secondary outcomes include incidence of hypotension, severe hypotension, bradycardia, reactive hypertension, intraoperative fluid requirements, blood loss, transfusion requirements, and postoperative nausea and vomiting. Hemodynamic parameters will be monitored throughout surgery to evaluate the safety and effectiveness of both vasopressor strategies.",[113,114],"Patients Undergoing Orthopedic Hip Surgery Under Spinal Anesthesia","Orthopedic Hip Sugery in Eldely Patients",[116],"Norepinehrine versus phenylepherine infusion in management of post-spinal hypotension","2026-06-22",{"date":119,"type":120},"2026-06-23","ACTUAL",{"date":122,"type":120},"2026-05-22",{"date":124,"type":107},"2027-03-14",{"name":5,"class":6},1]