Clinical Trial

Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation

Recruiting Phase 3
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Summary
The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine ("Ketofol") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations. Primary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 5, 10, 30, and then every 8h for 24 hours.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-21
Trial Details
NCT Number NCT07530146
Lead Sponsor Helwan University
Conditions The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia
Enrollment 41 participants
Start Date 2026-05-13
Primary Completion 2026-08 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-21