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Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
Sponsor: Helwan University
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, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2026-04
Completion Date
2026-10
Last Updated
2026-04-15
Healthy Volunteers
No
Interventions
Ketofol
Patients will take bolus dose of Propofol 0.25 mg/kg + Ketamine 0.25mg/kg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg/kg + Ketamine 0.25mg/kg IV
propofol (drug)
Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient
Locations (1)
Badr University hospital in Cairo
Cairo, Cairo Governorate, Egypt