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.
Eligibility
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)
