Safety and Effectiveness of Propofol-Ketamine Combination Compared to Propofol Alone in Elderly ICU Patients Needing Invasive Ventilation
Led by Helwan University · Updated on 2026-07-21
41
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination of propofol and ketamine Ketofol compared to propofol alone in critically ill elderly patients with cardiac disease who require endotracheal intubation in the intensive care unit ICU. The study focuses on how older patients respond differently to these drugs and aims to monitor side effects, especially related to blood pressure stability during and after intubation.
Participants will be randomly assigned to receive either a bolus dose of propofol combined with ketamine or propofol alone, with doses adjusted based on sedation needs and blood pressure. The propofol-ketamine group receives 0.25 mgkg of each drug as an initial dose, with additional doses if needed. The propofol-only group receives a starting dose of 0.5 mgkg, followed by smaller doses if sedation is insufficient. This treatment is administered intravenously during intubation.
During the study, participants mean arterial blood pressure will be closely monitored at baseline, during intubation, and at multiple time points up to 24 hours afterward. Heart rate will also be observed within the first hour. The study will assess the incidence of hemodynamic instability, defined as low blood pressure requiring vasopressors. Participation involves continuous monitoring in the ICU, and the study is scheduled to conclude by October 2026.
CONDITIONS
Brief Title
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
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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)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 24 hours
Participants receive intravenous doses of either propofol combined with ketamine or propofol alone during intubation. Dosing is adjusted based on sedation needs and blood pressure monitoring.
Continuous monitoring during ICU stay
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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Ketamine-propofol combination (ketofol) versus propofol alone for emergency department procedural sedation and analgesia: a randomized double-blind trial.
Gary Andolfatto, Riyad B Abu-Laban, Peter J Zed...