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Study aim
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Comparison of the effect of Haloperidol and Dexmedetomidine on delirium and agitation in patients under mechanical ventilation following concussion admitted to the ICU
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Design
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In this double-blind clinical trial study, 60 mechanically ventilated patients in the intensive care unit were randomly divided into intervention groups 1 and 2.
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Settings and conduct
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In this study, 60 patients under mechanical ventilation admitted to the ICU of Imam Khomeini Hospital in Ahvaz were selected by convenience sampling and randomly divided into two intervention groups 1 and 2. Patients in intervention group 1, in addition to routine care for 7 days, 2.5 mg of haloperidol in bolus and then 0.5 - 2 mg/h and patients in group 2, 1μg/kg of bolus dexmedetomidine and then 0.2-0.7 μg in Kg/h was injected by infusion. In order to blind in this study, the patient caregiver and statistical analyzer were unaware of the type of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include: Patients 18-65 years old with traumatic brain injury
APACHE II criteria more than 48, RASS criteria between +1 to +4, At least 48 hours after ICU admission. Exclusion criteria include: Dissatisfaction of the patient's legal guardian, Patients who are candidates for surgery, Unstable hemodynamic status, History of mental illness or use of neuroleptics, History of drug use any contraindications to dexmedetomidine or haloperidol (allergy, arkinson's, hypotension, bradycardia), Kidney or liver dysfunction
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Intervention groups
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In addition to routine care, for 7 days, Patients in the first group will be injected with 2.5 mg of haloperidol as a bolus and then 2.5-5 mg/h as an infusion of haloperidol. Micrograms per kilogram per hour will be infused with dexmedetomidine.
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Main outcome variables
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Delirium level, agitation rate, length of hospital stay, duration of mechanical ventilation and need for sedation