Clinical trial NCT06993194: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Delirium
Agitation
Keywords: Traumatic Brain Injury
Delirium Management
Agitation in Intensive Care
Haloperidol
Dexmedetomidine
Sedation in Brain Injury
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. One group will receive haloperidol and the other will receive dexmedetomidine. Each group will follow a predefined drug protocol without crossover between groups.
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Incidence of Delirium
timeFrame: Daily for 7 days following initiation of intervention
measure: Severity of Agitation
timeFrame: Daily for 7 days following initiation of intervention
Secondary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: Up to 14 days after intervention initiation or until extubation
measure: Length of Stay in the Intensive Care Unit
timeFrame: Up to 14 days after intervention initiation or until discharge from ICU
measure: Need for Rescue Sedation
timeFrame: Within 7 days following initiation of intervention
Other outcomes:
Locations:
Study officials:
References: