NCT07530146 Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
| NCT ID | NCT07530146 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Helwan University |
| Condition | The Critically Ill Patient is Requiring Intubation |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2026-04 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 41 participants in total. It began in 2026-04 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 * 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)
Frequently Asked Questions
Who can join the NCT07530146 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying The Critically Ill Patient is Requiring Intubation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07530146 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 41 participants.
Is NCT07530146 currently recruiting?
Yes, NCT07530146 is actively recruiting participants. Visit ClinicalTrials.gov or contact Helwan University to inquire about joining.
Where is the NCT07530146 trial being conducted?
This trial is being conducted at Cairo, Egypt, Cairo, Egypt.
Who is sponsoring the NCT07530146 clinical trial?
NCT07530146 is sponsored by Helwan University. The trial plans to enroll 41 participants.