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Compares treatment options for The Critically Ill Patient is Requiring Intubation
Official title Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
ClinicalTrials.gov ID: NCT07530146
What this study is testing
What is Ketofol?
Ketofol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for the critically ill patient is requiring intubation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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 treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.