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Neuroprotective Effects of Ketofol Versus Ketodex on Postoperative Delirium in Elderly Patients Undergoing Pelvi-abdominal Cancer Surgeries. A Randomized Double-blinded Comparative Study.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Kasr Alainy Faculty of Medicine- Cairo University
RECRUITING
Cairo
Contact Information
Primary
Abeer Ahmed, MD
abeer_ahmed@kasralainy.edu.eg
+201005244590
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2027-02
Participants
Target number of participants: 180
Treatments
Experimental: Group ketofol:
Experimental: Group ketodex
Placebo_comparator: Group Control
Related Therapeutic Areas
Sponsors
Leads: Cairo University

This content was sourced from clinicaltrials.gov