Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Helwan University
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Mean arterial blood pressure
Study Overview
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, 5, 10, 30, and then every 8h for 24 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Ketofol Group (Ketamine + Propofol)
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
Intervention: Ketofol (Drug)
Propofol group ( propofol monotherapy)
Patients will take Propofol lowest bolus dose of 0.5 mg/kg IV as monotherapy. If patient NOT sedated and need additional doses will be given another dose of 0.25 to 0.5 mg/kg after hemodynamically assessment
Intervention: propofol (drug) (Drug)
Outcomes
Primary Outcomes
Mean arterial blood pressure
Time Frame: 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.
Mean arterial blood pressure
Time Frame: baseline then at 1, 5, 10, , 30, and then every 8h for 24 hours
hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 5min 10min, , 30min , then every 8h for 24h.
Mean arterial pressure (MAP, mmHg) at 5 minutes
Time Frame: 5 minutes post induction
Mean arterial pressure (MAP, mmHg) at 5 minutes after administration of the induction agent
Secondary Outcomes
- Time to successful intubation(within 1 hours)
- Heart Rate(within 1 hours)
- 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)
- Diastolic blood pressure at 5 minutes after induction(5 minutes after induction)
- Incidence of hypotension(Post-induction period)
- Pain intensity score(within 24h)
- Sedation depth (RASS score)(From 30 minutes to 24 hours)
- Cumulative fentanyl consumption(During the study observation period)
- Adverse events(During ICU follow-up)
- All-cause ICU mortality(During ICU stay)
Investigators
Mujtaba Alqaisoum
Principal Investigator
Helwan University