Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury

Launched by BENHA UNIVERSITY · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is examining the effects of two different medications, haloperidol and dexmedetomidine, to help manage delirium and agitation in patients who have suffered a traumatic brain injury and are in the intensive care unit (ICU). Delirium is a state of confusion, while agitation refers to restlessness or extreme emotional disturbance. Both conditions are common in ICU patients and can make recovery more complicated and longer. The goal of the study is to see which medication is more effective and safer in treating these symptoms.

To participate in the trial, individuals must be adults aged 18 or older, have a confirmed traumatic brain injury, and be receiving mechanical ventilation in the ICU. They should also be showing signs of agitation, but not too severe. If someone is eligible and decides to participate, they will be randomly assigned to receive either haloperidol or dexmedetomidine. Throughout the study, their agitation and confusion levels will be closely monitored, and various tests will be conducted to ensure their safety. The findings from this research aim to help doctors make better treatment choices for ICU patients with traumatic brain injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 18 years or older
• • Confirmed diagnosis of traumatic brain injury
• • Admission to the intensive care unit
• • Currently receiving mechanical ventilation
• • Richmond Agitation-Sedation Scale score between -5 and +4
• • At least 48 hours have passed since ICU admission
• Exclusion Criteria:
• • Pre-existing neurological or psychiatric disorders (e.g., schizophrenia, bipolar disorder)
• • Known allergy or contraindication to haloperidol or dexmedetomidine
• • Significant hepatic or renal dysfunction
• • Pregnant or breastfeeding women
• • History of prolonged QT interval or other cardiac arrhythmias
• • Use of long-term antipsychotic or sedative medications before ICU admission