Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
Recruiting
Phase 3
Interventional Study
The Critically Ill Patient is Requiring Intubation
Septic Shock
Pneumonia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 65 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 41 (estimated)
- Sponsor
- Helwan University · Other
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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 g…
Trial Locations
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Eligibility Criteria
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
* …
Contacts
No contact information available.