Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Propofol: After an initial propofol bolus of 1mg/kg to achieve steady-state plasma concentration, children will be started on propofol at 1 mg/kg/hr, using a peripheral or a central ven
Sponsors
Post graduate institute of medical education and research
Eligibility
Inclusion criteria
Inclusion criteria: Acutely ill children mechanically ventilated in PICU and expected to remain ventilated for at least 12 hours after enrolment
Exclusion criteria
Exclusion criteria: Children on infusion of sedative drugs for more than 12 hours Significant hemodynamic instability (Vasoactive inotropic score more than 40) and not stabilized after appropriate intravenous volume replacement and vasoactives Primary cardiogenic shock Known pre existing neuromuscular or mitochondrial disorder Conditions requiring midazolam infusion like status epilepticus, status dystonicus, tetanus, etc Pancreatitis Post cardiac arrest state Raised intracranial pressure Profound encephalopathy due to the primary disease which can hinder assessment of level of sedation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time spent in the targeted sedation level in the first 72 hours after randomizationTimepoint: Till 72 hours after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Need for top-up doses of midazolam, propofol, fentanyl, and vecuroniumTimepoint: Till 72 hours after randomization;28 day ventilator free daysTimepoint: Till 28 days after randomization;Length of PICU and hospital stayTimepoint: From randomization till the time of discharge from PICU or hospital;28 day mortalityTimepoint: Till 28 days after randomization;Treatment failure rateTimepoint: Till 72 hours after randomization;Incidence of extubation failureTimepoint: Till 28 days after randomization;Incidence of adverse events related to sedationTimepoint: Till 72 hours after randomization;Incidence of occurrence of iatrogenic withdrawal syndrome and ICU deliriumTimepoint: Till 28 days after randomization | — |
Countries
India
Contacts
Public ContactDr Jayashree M
Postgraduate Institute of Medical Education and Research
Outcome results
None listed