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

Summary

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.

Conditions

• Traumatic Brain Injury
• Delirium
• Agitation

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 Intensive Care Unit and the Richmond Agitation-Sedation Scale.

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 the Intensive Care Unit and the Richmond Agitation-Sedation Scale.

Sponsors & Collaborators

• Benha University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-15

Primary Completion

2026-06-15

Completion

2026-06-15