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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age ≥ 65 years

• Admitted to ICU with a diagnosis of infection (sepsis, septic shock, or pneumonia)

• Known history of cardiac disease (e.g., ischemic heart disease, heart failure, arrhythmias)

• Requiring endotracheal intubation for airway protection or respiratory failure

• Informed consent obtained from patient or legal representative

• Patient NOT on sedation prior randomization.

Locations
Other Locations
Egypt
Badr University hospital in Cairo
RECRUITING
Cairo
Kasr Al Aini Hospital
RECRUITING
Cairo
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2026-10
Participants
Target number of participants: 41
Treatments
Experimental: Ketofol Group (Ketamine + Propofol)
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
Experimental: Propofol group ( propofol monotherapy)
Patients will take Propofol lowest bolus dose of 0.5 mg/kg IV as monotherapy. If patient NOT sedated and need additional doses will be given another dose of 0.25 to 0.5 mg/kg after hemodynamically assessment
Related Therapeutic Areas
Sponsors
Leads: Helwan University

This content was sourced from clinicaltrials.gov

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