Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery

Phase 3RecruitingNCT07627906

Cairo University180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

180

Interventions

Group ketofolDRUG

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 ketodexDRUG

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 ControlDRUG

will receive an equal volume of normal saline as 0.2 mg/kg/hr.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts