Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in G… (NCT07530146) | Clinical Trial Compass
RecruitingPhase 3
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
Egypt41 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Mean arterial blood pressure
Timeframe: baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours