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) 5 minutes after induction Secondary outcomes include changes in blood pressure and heart rate, incidence of hypotension, vasopressor requirements, sedation depth, pain scores, cumulative sedative and opioid consumption, adverse events, ICU length of stay, and ICU mortality at predefined intervals.
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 pressure (MAP, mmHg) at 5 minutes | 5 minutes post induction | Mean arterial pressure (MAP, mmHg) at 5 minutes after administration of the induction agent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor escalation within 5 minutes | 5 minutes | — |
| Peak norepinephrine dose within 5 minutes | 5 minutes | — |
| Systolic blood pressure at 5 minutes after induction | 5 minutes after induction | Systolic blood pressure measured in mmHg |
| Diastolic blood pressure at 5 minutes after induction | 5 minutes after induction | Diastolic blood pressure measured in mmHg |
| Incidence of hypotension | Post-induction period | — |
| Pain intensity score | within 24h | using CPOT score |
| Sedation depth (RASS score) | From 30 minutes to 24 hours | — |
| Cumulative fentanyl consumption | During the study observation period | — |
| Adverse events | During ICU follow-up | Incidence of Adverse events |
| All-cause ICU mortality | During ICU stay | — |
Countries
Egypt
Outcome results
None listed