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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Incidence of Delirium
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind study in which both the participants and the outcome assessors are unaware of the group assignments. Blinding is maintained through coded drug administration and identical infusion procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Haloperidol Group
Participants in this arm will receive intravenous haloperidol at a dose of 2.5 milligrams every eight hours, infused over ten minutes, starting 48 hours after admission to the intensive care unit. The intervention will continue for up to seven days or until resolution of delirium or agitation, whichever comes first. Rescue sedation with intravenous midazolam (1 milligram) and fentanyl (50 micrograms) may be administered if needed. Clinical assessments will include monitoring of delirium using the Confusion Assessment Method for the Intensive Care Unit, level of agitation using the Richmond Agitation-Sedation Scale, and consciousness using the Glasgow Coma Scale.
干预措施: Haloperidol (Drug)
Dexmedetomidine Group
Participants in this arm will receive intravenous dexmedetomidine at a dose of 0.5 micrograms per kilogram by continuous infusion, starting 48 hours after admission to the intensive care unit. The intervention will be administered every other day for up to seven days or until resolution of delirium or agitation. Rescue sedation with intravenous midazolam (1 milligram) and fentanyl (50 micrograms) may be administered if needed. Clinical assessments will include monitoring of delirium using the Confusion Assessment Method for the Intensive Care Unit, level of agitation using the Richmond Agitation-Sedation Scale, and consciousness using the Glasgow Coma Scale.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of Delirium
时间窗: Daily for 7 days following initiation of intervention
Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit. The presence or absence of delirium will be documented daily. The aim is to compare the incidence of delirium between patients receiving haloperidol and those receiving dexmedetomidine. Evaluations will be conducted by trained healthcare personnel blinded to the intervention group.
Severity of Agitation
时间窗: Daily for 7 days following initiation of intervention
Agitation will be measured using the Richmond Agitation-Sedation Scale. Scores will be recorded daily to evaluate the severity of agitation in both treatment groups. The objective is to compare the effectiveness of haloperidol and dexmedetomidine in reducing agitation severity. Richmond Agitation-Sedation Scale (RASS) The Richmond Agitation-Sedation Scale is a 10-point scale ranging from +4 (combative) to -5 (unarousable), used to assess agitation and sedation levels in critically ill patients. Scores of +1 to +4 indicate increasing agitation, 0 indicates alert and calm, and -1 to -5 indicate increasing sedation. It is widely used in intensive care settings to guide sedation and evaluate treatment response.
次要结局
- Duration of Mechanical Ventilation(Up to 14 days after intervention initiation or until extubation)
- Length of Stay in the Intensive Care Unit(Up to 14 days after intervention initiation or until discharge from ICU)
- Need for Rescue Sedation(Within 7 days following initiation of intervention)
研究者
Mohamed El-Sayed Abdelghany Nasef
Resident of Anaesthesia and Intensive Care, Faculty of Medicine, Benha University, Egypt
Benha University