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

Recruiting now · Phase 3

Conditions studied: The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia

In brief

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.

Key facts

Study ID

NCT07530146

Run by

Helwan University

People needed

41

Starts

2026-05-13

Expected to finish

2026-10-01

Last updated by the study team

2026-07-21

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known allergy or contraindication to propofol or ketamine
• Severe hepatic or renal dysfunction (Child-Pugh C, eGFR < 30 mL/min/1.73m²)
• Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
• Intracranial pathology (e.g., raised intracranial pressure, recent stroke, brain tumor)
• Ongoing use of other sedative or anesthetic agents within 12 hours prior to intubation
• Do-not-intubate or do-not-resuscitate orders
• Participation in another interventional trial within the last 30 days
• History of Psychosis
• Severe Organ Dysfunction: Patients with Child-Pugh C hepatic failure
• • Severe hypotension despite vasopressor therapy (systolic blood pressure < 100 mmHg or diastolic blood pressure < 70 mmHg)

Where it is running

• Kasr Al Aini Hospital — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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