NCT07627906 Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery
| NCT ID | NCT07627906 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cairo University |
| Condition | Postoperative Delirium (POD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2026-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07627906 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Postoperative Delirium (POD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07627906 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT07627906 currently recruiting?
Yes, NCT07627906 is actively recruiting participants. Contact the research team at abeer_ahmed@kasralainy.edu.eg for enrollment information.
Where is the NCT07627906 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07627906 clinical trial?
NCT07627906 is sponsored by Cairo University. The trial plans to enroll 180 participants.