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Recruiting Phase 3 NCT07530146

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

Phase 3 – large-scale trial before approval
Conditions: The Critically Ill Patient is Requiring Intubation Septic Shock Pneumonia

Sponsor: Helwan University

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Overview
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.
Who can participate
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)
Interventions
Ketofol
DRUG
propofol (drug)
DRUG
Locations 1
Egypt (1)
Badr University hospital in Cairo
Cairo , Cairo Governorate
Ahmed Abdelrahman Mohamed Mohamed El-Tawansy Dr. El-Tawansy
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
65 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.10.2026
Registry ID
NCT07530146
Source
clinicaltrials.gov
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