Ketofol: 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
propofol (drug): Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient
Study 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, 5, 10, 30, and then every 8h for 24 hours.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Mean arterial pressure (MAP, mmHg) at 5 minutes — 5 minutes post induction Mean arterial pressure (MAP, mmHg) at 5 minutes after administration of the induction agent
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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