Propofol plus ketamine versus propofol alone for sedating older ICU patients on ventilators
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
This trial tests if adding ketamine to propofol helps critically ill patients aged 65 and older who need intubation keep their blood pressure more stable than propofol alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Helwan University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07530146 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized Phase 3 trial enrolling geriatric ICU patients with infection and known cardiac disease who require endotracheal intubation and have not yet received sedation. Participants are randomized to receive either a propofol‑ketamine combination (ketofol) or propofol monotherapy during intubation and early mechanical ventilation. The primary outcome is incidence of hemodynamic instability, defined by hypotension requiring vasopressors, with mean arterial pressure recorded at baseline, during intubation, at multiple early time points up to 60 minutes, then hourly for 24 hours. The trial is conducted at Badr University Hospital in Cairo under Helwan University sponsorship.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 or older in the ICU with sepsis, septic shock, or pneumonia who have known cardiac disease, require endotracheal intubation, and are not yet sedated.
Not a fit: Patients with severe liver or kidney failure, uncontrolled hypertension, intracranial pathology, recent psychosis, allergies to propofol or ketamine, do-not-intubate/resuscitate orders, or recent use of other sedatives are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could reduce episodes of low blood pressure around intubation and lower the need for vasopressor support in elderly ICU patients.
How similar studies have performed: Previous procedural and emergency‑department studies suggest ketamine or ketofol can reduce hypotension compared with propofol alone, but randomized data specifically in elderly ICU intubations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Cairo, Cairo Governorate
- Badr University hospital in Cairo — Cairo, Cairo Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.