Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery

ConditionPostoperative Delirium (POD)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age60+

SponsorCairo University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥ 60 years.

ASA physical status II and III.

Scheduled for open pelvi-abdominal cancer surgeries.

Able to communicate verbally.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Group ketofol
Drug
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/ml). The infused ketofol dose will be 0.2 ml/kg/hr.
Group ketodex
Drug
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/ml). The infused ketodex dose will be 0.2 ml/kg/hr.
Group Control
Drug
will receive an equal volume of normal saline as 0.2 mg/kg/hr.

Treatment groups

180 Participants

are divided into 3 treatment groups

Group A: Group ketofol:Experimental treatment 1 intervention

Group B: Group ketodexExperimental treatment 1 intervention

Group C: Group ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of POD two hours postoperative using 3D-CAM test.

Time frame

2 hours postoperative

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

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