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

Official title

Comparison Between the Effects of Haloperidol and Dexmedetomidine on Delirium and Agitation in Patients With a Traumatic Brain Injury Admitted to the Intensive Care Unit

Overview

Traumatic brain injury is a serious and common medical condition that often requires admission to the intensive care unit and the use of mechanical ventilation. One of the most frequent and challenging complications in these patients is the development of delirium and agitation. These symptoms can prolong hospitalization, increase the risk of further brain injury, and complicate the medical and nursing care of the patient. This interventional clinical trial is designed to compare the effects of two medications-haloperidol and dexmedetomidine-on the management of delirium and agitation in patients with traumatic brain injury admitted to the intensive care unit. Haloperidol is a traditional antipsychotic medication that is commonly used to manage agitation, but it may cause undesirable side effects such as movement disorders and disturbances in heart rhythm. Dexmedetomidine is a medication that acts on specific receptors in the nervous system to produce sedation and reduce agitation, and it is believed to cause fewer side effects related to breathing and movement. The study will include forty adult patients with confirmed traumatic brain injury. These patients will be randomly assigned to receive either haloperidol or dexmedetomidine according to standard dosing guidelines. The study will evaluate and compare the following outcomes in both treatment groups: the presence and severity of delirium, the level of agitation, the total number of days the patient requires mechanical ventilation, the length of stay in the intensive care unit, the need for additional sedative medications, and the occurrence of any harmful effects from the study drugs. To measure these outcomes, patients will be monitored using standardized tools that assess consciousness, agitation levels, and the presence of confusion. Additional medical examinations and laboratory tests will be conducted to ensure patient safety and collect relevant clinical data. This study will be carried out in accordance with the ethical guidelines outlined in the Declaration of Helsinki and will follow internationally accepted standards for research involving human participants. Approval has been granted by the appropriate medical ethics committee at the Faculty of Medicine, Benha University. Informed consent will be obtained from all patients or their legal representatives before participation. The purpose of this research is to provide scientific evidence that can help doctors choose the most appropriate and safe medication for managing delirium and agitation in patients with traumatic brain injury who are being treated in the intensive care unit.

Interventions

• Drug Haloperidol
  Haloperidol will be administered intravenously at a dose of 2.5 milligrams every eight hours over ten minutes. Treatment will begin 48 hours after admission to the intensive care unit and will continue for up to seven days or until delirium and agitation resolve. The need for additional sedation will be addressed with intravenous midazolam and fentanyl as required. The patient's clinical status will be monitored using standardized assessments including the Confusion Assessment Method for the Int
• Drug Dexmedetomidine
  Dexmedetomidine will be administered by continuous intravenous infusion at a dose of 0.5 micrograms per kilogram. Treatment will begin 48 hours after admission to the intensive care unit and will be repeated every other day for up to seven days or until delirium and agitation resolve. Rescue sedation may be provided with intravenous midazolam and fentanyl as clinically indicated. Delirium and agitation will be assessed regularly using validated tools such as the Confusion Assessment Method for t

Primary outcome measures

• Incidence of Delirium [Time frame: Daily for 7 days following initiation of intervention]
• Severity of Agitation [Time frame: Daily for 7 days following initiation of intervention]

Secondary outcome measures (3)

• Duration of Mechanical Ventilation [Time frame: Up to 14 days after intervention initiation or until extubation]
• Length of Stay in the Intensive Care Unit [Time frame: Up to 14 days after intervention initiation or until discharge from ICU]
• Need for Rescue Sedation [Time frame: Within 7 days following initiation of intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06993194 · MD-990-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗