Actively Recruiting
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
Led by Helwan University · Updated on 2026-04-20
41
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �03E�3D 65 years
- Admitted to ICU with infection diagnosis (sepsis, septic shock, or pneumonia)
- Known history of cardiac disease such as ischemic heart disease, heart failure, or arrhythmias
- Requires endotracheal intubation for airway protection or respiratory failure
- Informed consent obtained from patient or legal representative
- Patient not on sedation before randomization
You will not qualify if you...
- Known allergy or contraindication to propofol or ketamine
- Severe liver or kidney problems (Child-Pugh C, eGFR < 30 mL/min/1.73m8)
- Uncontrolled high blood pressure (systolic > 180 mmHg or diastolic > 110 mmHg)
- Brain conditions such as raised pressure, recent stroke, or brain tumor
- Use of other sedatives or anesthetics within 12 hours before intubation
- Do-not-intubate or do-not-resuscitate orders
- Participation in another interventional trial within the last 30 days
- History of psychosis
- Severe organ failure (Child-Pugh C liver failure)
- Severe low blood pressure despite vasopressors (systolic < 100 mmHg or diastolic < 70 mmHg)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Badr University hospital in Cairo
Cairo, Cairo Governorate, Egypt, 4942340
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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