Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery

May 30, 2026 updated by: Abeer Ahmed, MD, Cairo University

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11728
        • Recruiting
        • Kasr Alainy Faculty of Medicine- Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group Control
Drug: Group Control
will receive an equal volume of normal saline as 0.2 mg/kg/hr.
Experimental: Group ketofol:
Drug: Group ketofol
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.
Experimental: Group ketodex
Drug: Group ketodex
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of POD two hours postoperative using 3D-CAM test.
Time Frame: 2 hours postoperative
2 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-394-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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