Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Aug 2026 → Oct 2026
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Oct 2026 to Sep 18, 2026
    • Site details revised
  2. Enrollment increased: 41 → 70 participants Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Primary completion pushed from Aug 2026 to Oct 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 1 to 10
    • Publications: details revised at 4 of 4 entries
  3. Re-verified, no change to tracked fieldsv6
  4. Secondary endpoint revisedv5
  5. Study sites: 2 to 1
    • Start date changed from estimate of Apr 2026 to May 13, 2026
    v4
  6. Study sites: 1 to 2v3
  7. Recruitment opened
    • Site details revised
    v2
  8. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07530146
Lead Sponsor Helwan University
Conditions
(from sponsor)		 The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia
Related terms Pneumonia, Shock, Septic
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov