Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery

Recruiting now · Phase 3

Conditions studied: Postoperative Delirium (POD)

In brief

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 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. Combinations 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.

Key facts

Study ID

NCT07627906

Run by

Cairo University

People needed

180

Starts

2026-07-01

Expected to finish

2027-02-01

Last updated by the study team

2026-06-04

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kasr Alainy Faculty of Medicine- Cairo University — Cairo, Cairo Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.