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

Helwan University

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Ketofol; Drug: propofol (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT07530146

10H2025

Details and patient eligibility

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Ketofol Group (Ketamine + Propofol)

Experimental group

Description:

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

Treatment:

Drug: Ketofol

Propofol group ( propofol monotherapy)

Experimental group

Description:

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

Treatment:

Drug: propofol (drug)