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NCT Number: NCT07530146

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

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.

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Key information

Conditions

The Critically Ill Patient is Requiring Intubation Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Mean arterial blood pressure

    Time frame: baseline then at 1, 5, 10, , 30, and then every 8h for 24 hours

    hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 5min 10min, , 30min , then every 8h for 24h.

Secondary outcomes

  1. Heart Rate

    Time frame: within 1 hours

    mean difference in HR

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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