Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery

NCT07627906 | Recruiting Phase 3

• 1 other identifier: MS-394-2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium (POD)

Keywords

ketofol; ketodex; ketamine; dexmedetomidine; postoperative delirium; postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

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

  2 hours postoperative

Study Arms (3)

Group ketofol:

EXPERIMENTAL

Drug: Group ketofol

Group ketodex

EXPERIMENTAL

Drug: Group ketodex

Group Control

PLACEBO COMPARATOR

Drug: Group Control

Interventions

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 ketofol:

Group Control DRUG

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

Group Control

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 ketodex

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Faculty of Medicine- Cairo University

Cairo, Cairo Governorate, 11728, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Abeer Ahmed, MD

CONTACT

+201005244590; abeer_ahmed@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

EG (1)