[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633704":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":29,"responsibleParty":69,"collaborators":24,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":24,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":24,"enrollmentInfo":79,"targetDuration":24,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":32,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Helwan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketofol Group (Ketamine + Propofol)","EXPERIMENTAL","Patients will take bolus dose of Propofol 0.25 mg\u002Fkg + Ketamine 0.25mg\u002Fkg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg\u002Fkg + Ketamine 0.25mg\u002Fkg IV",[13],"Drug: Ketofol",{"label":15,"type":10,"description":16,"interventionNames":17},"Propofol group ( propofol monotherapy)","Patients will take Propofol lowest bolus dose of 0.5 mg\u002Fkg IV as monotherapy. If patient NOT sedated and need additional doses will be given another dose of 0.25 to 0.5 mg\u002Fkg after hemodynamically assessment",[18],"Drug: propofol (drug)",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Ketofol",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"propofol (drug)","Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient",[15],[30,55],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Badr University hospital in Cairo","RECRUITING","Cairo","Cairo Governorate","4942340","Egypt","EG",{"type":39,"coordinates":40},"Point",[41,42],31.24967,30.06263,{"lat":42,"lon":41},[45,50,53],{"name":46,"role":47,"phone":48,"phoneExt":24,"email":49},"Ahmed Abdelrahman Mohamed Mohamed El-Tawansy Dr. El-Tawansy","CONTACT","+201005125451","ahmed.tawansy@med.helwan.edu.eg",{"name":51,"role":52,"phone":24,"phoneExt":24,"email":24},"Mujtaba monir Alqaisoum, Bachelor","PRINCIPAL_INVESTIGATOR",{"name":54,"role":52,"phone":24,"phoneExt":24,"email":24},"Mahmoud ibrahim Mostafa, PhD",{"facility":56,"status":32,"city":33,"state":24,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Kasr Al Aini Hospital",{"type":39,"coordinates":58},[41,42],{"lat":42,"lon":41},[61,65,67],{"name":62,"role":47,"phone":63,"phoneExt":24,"email":64},"Ahmed Elsaeed Elshall","+201002998841","dr.ahmedelshall@gmail.com",{"name":24,"role":47,"phone":24,"phoneExt":24,"email":66},"malqaisoom@gmail.com",{"name":68,"role":52,"phone":24,"phoneExt":24,"email":24},"Mujtaba Alqaisoum",{"type":52,"investigatorFullName":68,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Principal Investigator","100633704","phase-3-comparative-efficacy-and-safety-of-propofol-ketamine-combination-versus-propofol-monotherapy-in-geriatric-patients-under-invasive-ventilation-100633704",false,"NCT07530146","Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Admitted to ICU with a diagnosis of infection (sepsis, septic shock, or pneumonia)\n* Known history of cardiac disease (e.g., ischemic heart disease, heart failure, arrhythmias)\n* Requiring endotracheal intubation for airway protection or respiratory failure\n* Informed consent obtained from patient or legal representative\n* Patient NOT on sedation prior randomization.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to propofol or ketamine\n* Severe hepatic or renal dysfunction (Child-Pugh C, eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Uncontrolled hypertension (SBP \\> 180 mmHg or DBP \\> 110 mmHg)\n* Intracranial pathology (e.g., raised intracranial pressure, recent stroke, brain tumor)\n* Ongoing use of other sedative or anesthetic agents within 12 hours prior to intubation\n* Do-not-intubate or do-not-resuscitate orders\n* Participation in another interventional trial within the last 30 days\n* History of Psychosis\n* Severe Organ Dysfunction: Patients with Child-Pugh C hepatic failure\n* • Severe hypotension despite vasopressor therapy (systolic blood pressure \\\u003C 100 mmHg or diastolic blood pressure \\\u003C 70 mmHg)","ALL","65 Years",{"count":80,"type":81},41,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine (\"Ketofol\") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations.\n\nPrimary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.",[87,88,89],"The Critically Ill Patient is Requiring Intubation","Septic Shock","Pneumonia",[91,92,93,94,95,96,97,98,99],"ketofol","propofol","septic shock","pneumonia","geriatric","elderly","critical ill","ICU patient","intubation","2026-05-28",{"date":102,"type":103},"2026-06-01","ACTUAL",{"date":105,"type":81},"2026-04",{"date":107,"type":81},"2026-10",{"name":5,"class":6},2]