Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in G… (NCT07530146) | Clinical Trial Compass
RecruitingPhase 3
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
Egypt41 participantsStarted 2026-04
Plain-language 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, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean arterial blood pressure
Timeframe: baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours