Actively Recruiting
Neuroprotective Effects of Ketofol Versus Ketodex on Postoperative Delirium in Elderly Patients Undergoing Pelvi-abdominal Cancer Surgeries
Led by Cairo University · Updated on 2026-06-04
180
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Postoperative delirium (POD) is a frequent and serious brain-related complication following surgery, especially in older adults having major cancer operations. It can lead to longer hospital stays, reduced quality of life, lasting cognitive problems, and higher risk of death. This trial compares two drug combinations, ketofol and ketodex, which are being studied for their potential to protect the brain and prevent POD in elderly patients undergoing pelvic and abdominal cancer surgeries. Participants will be randomly assigned to receive one of three treatments during surgery: ketofol, a mix of propofol and ketamine; ketodex, a mix of ketamine and dexmedetomidine; or a placebo of normal saline. Both ketofol and ketodex are given through an intravenous infusion at a set rate based on weight. These treatments are designed to provide sedation, pain relief, and possibly reduce brain inflammation, while minimizing side effects. The study is double-blinded, meaning neither the patients nor the researchers know which treatment is given. During the study, participants will be monitored closely, with the main focus on detecting postoperative delirium two hours after surgery using a specific test called the 3D-CAM. Researchers will also assess safety and other health outcomes. The trial is led by Cairo University and will follow participants from surgery through their recovery to better understand how these treatments affect brain health after cancer surgery in older adults.
CONDITIONS
Brief Title
Ketofol Versus Ketodex for POD Prophylaxis in Elderly Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 60 years or older
- ASA physical status II or III
- Scheduled for open pelvi-abdominal cancer surgeries
- Able to communicate verbally
- Body mass index (BMI) less than 35 kg/m2
You will not qualify if you...
- Patient's refusal to participate
- Undergoing laparoscopic procedures
- Severe liver impairment (liver enzymes more than threefold normal)
- Severe kidney impairment (creatinine clearance less than 30 ml/min)
- Severe heart disease (ejection fraction 40% or less, recent heart attack within 3 months, NYHA class III or higher)
- Severe lung disease (FEV1/FVC ratio less than 50% predicted and/or FEV1 less than 50% predicted)
- Patients requiring postoperative ICU admission with mechanical ventilation or inotropic support
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During surgery
Participants receive one of the study drugs: Ketofol, Ketodex, or a placebo infusion during their surgery to help prevent postoperative delirium.
1 in-person treatment session during surgery
Trial Site Locations
Total: 1 location
1
Kasr Alainy Faculty of Medicine- Cairo University
Cairo, Cairo Governorate, Egypt, 11728
Actively Recruiting
Research Team
A
Abeer Ahmed, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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