Ketofol vs Ketodex for preventing delirium after major cancer surgery in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial compares three approaches to prevent postoperative delirium in elderly cancer patients undergoing open pelvi-abdominal surgery. Participants are assigned to receive ketofol, ketodex, or standard care to see which strategy best reduces delirium after surgery. The study targets patients with ASA II–III who can communicate and are not undergoing laparoscopic procedures. Key safety considerations include avoiding recruitment of those with severe organ dysfunction or requiring postoperative ICU support. Conducted at Kasr Alainy Faculty of Medicine, the trial is led by Cairo University with no stated collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Abeer Ahmed, MD
• Email: abeer_ahmed@kasralainy.edu.eg
• Phone: +201005244590

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.