The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia
Conditions
Keywords
ketofol, propofol, septic shock, pneumonia, geriatric, elderly, critical ill, ICU patient, intubation
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.
Interventions
DRUGKetofol
Patients will take bolus dose of Propofol 0.25 mg/kg + Ketamine 0.25mg/kg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg/kg + Ketamine 0.25mg/kg IV
DRUGpropofol (drug)
Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial blood pressure | baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours | hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 3min , 5min 10min, 20min , 30min , 60min then hourly for 24h. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to successful intubation | within 1 hours | Time to successful intubation (from induction to tube placement confirmation |
Countries
Egypt
Outcome results
None listed