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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorHelwan University

About this trial

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, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

41 Participants
are divided into 2 treatment groups
Group A: Ketofol Group (Ketamine + Propofol)Experimental treatment 1 intervention
Group B: Propofol group ( propofol monotherapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean arterial blood pressure

hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 3min , 5min 10min, 20min , 30min , 60min then hourly for 24h.

Time frame
baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours

Secondary outcomes

1

Time to successful intubation

Time to successful intubation (from induction to tube placement confirmation

Time frame
within 1 hours

Other outcomes

Sponsors and contacts

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