[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637300":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":35,"locations":41,"responsibleParty":60,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group ketofol:","EXPERIMENTAL",null,[13],"Drug: Group ketofol",{"label":15,"type":10,"description":11,"interventionNames":16},"Group ketodex",[17],"Drug: Group ketodex",{"label":19,"type":20,"description":11,"interventionNames":21},"Group Control","PLACEBO_COMPARATOR",[22],"Drug: Group Control",[24,29,32],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","Group ketofol","Patients will receive Ketofol (propofol- ketamine mixture in a ratio of 1:1). This will be prepared by adding 200 mg propofol (20 ml) with 200 mg ketamine (4ml) in 50 ml infusion (concentration of 4mg\u002Fml). The infused ketofol dose will be 0.2 ml\u002Fkg\u002Fhr.",[9],{"type":25,"name":15,"description":30,"armGroupLabels":31,"otherNames":11},"Patients will receive Ketodex (ketamine- dexmedetomidine mixture in a ratio of 1:1). This will be prepared by adding 200 mg dexmedetomidine (2 ml) with 200 mg ketamine (4ml) to be diluted with normal saline within 50 ml infusion (concentration 4mg\u002Fml). The infused ketodex dose will be 0.2 ml\u002Fkg\u002Fhr.",[15],{"type":25,"name":19,"description":33,"armGroupLabels":34,"otherNames":11},"will receive an equal volume of normal saline as 0.2 mg\u002Fkg\u002Fhr.",[19],[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Abeer Ahmed, MD","CONTACT","+201005244590","abeer_ahmed@kasralainy.edu.eg",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Kasr Alainy Faculty of Medicine- Cairo University","RECRUITING","Cairo","Cairo Governorate","11728","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],31.24967,30.06263,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":11,"email":40},"Abeer Said, MD","01005244590",{"type":61,"investigatorFullName":37,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Professor","100637300","phase-3-ketofol-versus-ketodex-for-pod-prophylaxis-in-elderly-cancer-surgery-100637300",false,"NCT07627906","Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery","Neuroprotective Effects of Ketofol Versus Ketodex on Postoperative Delirium in Elderly Patients Undergoing Pelvi-abdominal Cancer Surgeries. A Randomized Double-blinded Comparative Study.","Inclusion Criteria:\n\n* Patients aged ≥ 60 years.\n* ASA physical status II and III.\n* Scheduled for open pelvi-abdominal cancer surgeries.\n* Able to communicate verbally.\n* BMI \\\u003C 35 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Patient's refusal to participate.\n* Laparoscopic procedures.\n* Severe hepatic (Liver enzymes are more than threefold) and renal impairment (Creatinine clearance is less than 30 ml\u002Fmin).\n* Severe cardiac disease (EF ≤ 40%, recent MI in the previous 3 months, NYHA ≥ III) and pulmonary disease (FEV1\u002FFVC ratio \\\u003C 50% predicted and\u002For FEV1 \\\u003C 50% predicted)\n* Patients require postoperative ICU admission with mechanical ventilation and or inotropic support.","ALL","60 Years",{"count":73,"type":74},180,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","Postoperative delirium (POD) is a common and serious neurocognitive complication after surgery, particularly in elderly patients undergoing major cancer surgeries. It is associated with prolonged hospital stay, impaired quality of life, increased postoperative cognitive dysfunction, and higher mortality. The pathophysiology of POD is multifactorial and involves neuroinflammation, oxidative stress, impaired cerebral perfusion, and neurotransmitter imbalance.\n\nSeveral anesthetic agents have been investigated for their potential neuroprotective effects against POD. Ketamine, through NMDA receptor antagonism, may reduce neuroinflammation and provide hemodynamic stability and opioid-sparing analgesia, although concerns remain regarding hallucinations and psychomimetic effects. Propofol, acting through GABA receptor activation, may protect against oxidative neuronal injury but may also induce hypotension in elderly patients. Dexmedetomidine, a selective α2-adrenergic agonist, has shown promising sedative, analgesic, and anti-inflammatory properties with potential protective effects against POD, although bradycardia and uncertainty regarding optimal dosing remain concerns.\n\nCombinations such as ketofol (ketamine-propofol) and ketodex (ketamine-dexmedetomidine) may provide synergistic benefits by improving hemodynamic stability, analgesia, and sedation while minimizing adverse effects. Previous studies have demonstrated favorable perioperative outcomes with both combinations; however, direct comparisons regarding their role in preventing postoperative delirium in elderly patients undergoing pelvi-abdominal cancer surgeries remain limited. Therefore, this study aims to compare the efficacy and safety of ketofol versus ketodex as prophylactic strategies against POD in this high-risk population.",[80],"Postoperative Delirium (POD)",[82,83,84,85,86,87],"ketofol","ketodex","ketamine","dexmedetomidine","postoperative delirium","postoperative cognitive dysfunction","2026-05-30",{"date":90,"type":91},"2026-06-04","ACTUAL",{"date":93,"type":74},"2026-07",{"date":95,"type":74},"2027-02",{"name":5,"class":6},1]