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Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery

RecruitingPhase 3Ages 60 Years - anyAllCairo University
NCT07627906 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Several 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged ≥ 60 years. * ASA physical status II and III. * Scheduled for open pelvi-abdominal cancer surgeries. * Able to communicate verbally. * BMI \< 35 kg/m2. Exclusion Criteria: * Patient's refusal to participate. * Laparoscopic procedures. * Severe hepatic (Liver enzymes are more than threefold) and renal impairment (Creatinine clearance is less than 30 ml/min). * Severe cardiac disease (EF ≤ 40%, recent MI in the previous 3 months, NYHA ≥ III) and pulmonary disease (FEV1/FVC ratio \< 50% predicted and/or FEV1 \< 50% predicted) * Patients require postoperative ICU admission with mechanical ventilation and or inotropic support.
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What it tests

  • Group ketofol
  • Group ketodex
  • Group Control
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Where

1 site
Kasr Alainy Faculty of Medicine- Cairo University
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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