Traumatic Brain InjuryNCT06993194
Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury
A study testing Haloperidol and Dexmedetomidine in people with Traumatic Brain Injury and Delirium, run by Benha University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Delirium, Agitation
- What is being tested?
- Haloperidol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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
- Being tested
- Haloperidol, Dexmedetomidine
- Keywords
- Traumatic Brain Injury, Delirium Management, Agitation in Intensive Care, Haloperidol, Dexmedetomidine, Sedation in Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
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.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol Group | Active comparator | 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. Receives: Drug: Haloperidol |
| Dexmedetomidine Group | Experimental | 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delirium
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.
Measured: Daily for 7 days following initiation of intervention
Severity of Agitation
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.
Measured: Daily for 7 days following initiation of intervention
Secondary outcomes (3)
Duration of Mechanical Ventilation
The total number of days that each patient remains on mechanical ventilation will be recorded. The aim is to assess whether treatment with dexmedetomidine or haloperidol is associated with shorter ventilator dependency.
Measured: Up to 14 days after intervention initiation or until extubation
Length of Stay in the Intensive Care Unit
The number of days each patient spends in the intensive care unit will be recorded to evaluate the impact of the assigned intervention on intensive care unit stay duration.
Measured: Up to 14 days after intervention initiation or until discharge from ICU
Need for Rescue Sedation
The number of patients requiring additional sedation with intravenous midazolam and fentanyl will be documented. This measure will compare the adequacy of haloperidol and dexmedetomidine in controlling delirium and agitation without supplemental sedatives.
Measured: Within 7 days following initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El-Sayed Abdelghany Nasef, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993194
- Sponsor's protocol ID
- MD-990-2025
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this study will be shared, including data on demographics, intervention allocation, outcome measures (such as delirium incidence, agitation scores, ICU stay, and adverse events), and baseline clinical characteristics.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06993194
- Acronym / sponsor ID
- MD-990-2025
- Conditions
- Traumatic Brain Injury, Delirium, Agitation
- Keywords
- Traumatic Brain Injury, Delirium Management, Agitation in Intensive Care, Haloperidol, Dexmedetomidine, Sedation in Brain Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Haloperidol Group | Active comparator | Drug: HaloperidolParticipants 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. |
| Dexmedetomidine Group | Experimental | Drug: DexmedetomidineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolHaloperidol 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 | Haloperidol Group |
| DexmedetomidineDexmedetomidine 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. | Drug | Dexmedetomidine Group |
Primary outcome
Incidence of Delirium
Time frame: 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
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this study will be shared, including data on demographics, intervention allocation, outcome measures (such as delirium incidence, agitation scores, ICU stay, and adverse events), and baseline clinical characteristics.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Haloperidol and Dexmedetomidine in people with Traumatic Brain Injury and Delirium, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Nasef, MSc (0 100 146 3679 ext. +2, drsmart150@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delirium (time frame: Daily for 7 days following initiation of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.