About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Ketofol
DrugPatients 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
propofol (drug)
DrugPropofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient
Treatment groups
Trial outcomes
Primary outcomes
Mean arterial pressure (MAP, mmHg) at 5 minutes
Mean arterial pressure (MAP, mmHg) at 5 minutes after administration of the induction agent
Secondary outcomes
Vasopressor escalation within 5 minutes
Peak norepinephrine dose within 5 minutes
Systolic blood pressure at 5 minutes after induction
Systolic blood pressure measured in mmHg
Diastolic blood pressure at 5 minutes after induction
Diastolic blood pressure measured in mmHg
Sponsors and contacts
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