Trial · NCT06993194
Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury
NCT06993194, Not applicable, Not yet recruiting, Benha University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury. Trials, record NCT06993194. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06993194
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury
- NCT number
- NCT06993194
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Benha University
- Conditions
- Traumatic Brain Injury, Delirium, Agitation
- Interventions
- Haloperidol, Dexmedetomidine
- First posted
- 2025-05-28
- Last updated
- 2025-05-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Delirium | 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. |
| Primary | Severity of Agitation | 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. |
| Secondary | Duration of Mechanical Ventilation | Up to 14 days after intervention initiation or until extubation | 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. |
| Secondary | Length of Stay in the Intensive Care Unit | Up to 14 days after intervention initiation or until discharge from ICU | 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. |
| Secondary | Need for Rescue Sedation | Within 7 days following initiation of intervention | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06993194
GET https://conductscience.org/api/trials/v1/NCT06993194/registered