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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
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
Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient
Kasr Al Aini Hospital
Cairo, Egypt
RECRUITINGMean arterial pressure (MAP, mmHg) at 5 minutes
Mean arterial pressure (MAP, mmHg) at 5 minutes after administration of the induction agent
Time frame: 5 minutes post induction
Vasopressor escalation within 5 minutes
Time frame: 5 minutes
Peak norepinephrine dose within 5 minutes
Time frame: 5 minutes
Systolic blood pressure at 5 minutes after induction
Systolic blood pressure measured in mmHg
Time frame: 5 minutes after induction
Diastolic blood pressure at 5 minutes after induction
Diastolic blood pressure measured in mmHg
Time frame: 5 minutes after induction
Incidence of hypotension
Time frame: Post-induction period
Pain intensity score
using CPOT score
Time frame: within 24h
Sedation depth (RASS score)
Time frame: From 30 minutes to 24 hours
Cumulative fentanyl consumption
Time frame: During the study observation period
Adverse events
Incidence of Adverse events
Time frame: During ICU follow-up
All-cause ICU mortality
Time frame: During ICU stay
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