Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 17, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07530146). This is a study registration, not published results. Lead sponsor: Helwan University. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia. Interventions: DRUG: Ketofol; DRUG: propofol (drug). Primary outcome measures: Mean arterial pressure (MAP, mmHg) at 5 minutes , 5 minutes post induction. Brief 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.