NCT07530146

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Helwan University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• The Critically Ill Patient is Requiring Intubation
• Septic Shock
• Pneumonia

Interventions

Type	Name	Description
DRUG	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
DRUG	propofol (drug)	Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Egypt