| Registry | NCT07530146 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 70 (Estimated) |
| Sponsor | Helwan University (Other) |
| Conditions | The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia |
| Interventions | Ketofol, propofol (drug) (Drug) |
| Dates | start 2026-05-13, primary completion 2026-09-18, completion 2026-10-01 (estimated), first posted 2026-04-15, last updated 2026-10-15 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for The Critically Ill Patient is Requiring Intubation All trials for Septic Shock All trials of Ketofol All trials of propofol (drug)
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) 5 minutes after induction
Secondary outcomes include changes in blood pressure and heart rate, incidence of hypotension, vasopressor requirements, sedation depth, pain scores, cumulative sedative and opioid consumption, adverse events, ICU length of stay, and ICU mortality at predefined intervals.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ketofol Group (Ketamine + Propofol) | Experimental | Drug: 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 group ( propofol monotherapy) | Experimental | Drug: propofol (drug) | Patients will take Propofol lowest bolus dose of 0.5 mg/kg IV as monotherapy. If patient NOT sedated and need additional doses will be given another dose of 0.25 to 0.5 mg/kg after hemodynamically assessment |
Sex: All, ages: 65 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Kasr Al Aini Hospital | Cairo | Egypt |