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

Sponsor
Helwan University
Study ID
NCT07530146
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pneumonia
  • Septic Shock
  • The Critically Ill Patient is Requiring Intubation

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketofol — DRUG
    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) — DRUG
    Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient

Study Details

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.

Key Dates

First listed
Apr 15, 2026
Start date
May 13, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
41 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketofol Group (Ketamine + Propofol)
    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
  • Experimental: Propofol group ( propofol monotherapy)
    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

Primary Outcome Measure

Mean arterial blood pressure [ Time Frame: baseline then at 1, 5, 10, , 30, and then every 8h for 24 hours ]

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