A Phase 3 interventional study of propranolol and normal saline IV in Traumatic Brain Injury (TBI) Patients, Intracranial Pressure and Intensive Care Unit, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Tanta University · Phase 3, Interventional, and Prevention
The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury
The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia.
Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality .
β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury .
A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 60 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days.
Drug: propranolol
This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days
Drug: normal saline IV
This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days, and doses will be held if heart rate less than 60 bpm, mean arterial pressure less than 65 mmHg
Also known as: Experimental group
This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days
Also known as: control group
Mortality
Mortality in severe traumatic brain injury with usage of β blocker
Time frame: 7 days
Glascow outcome scale extended
Glascow outcome scale extended) consists of 8 categories: Death Persistent vegetative state: awake not aware. Lower severe disability: dependent, require help most of time. Upper severe disability: dependent, can be left alone some time. Iower moderate disability: independent, unable to work. Upper moderate disability: independent, reduced work capacity. Lower good recovery: minor problems that affect daily activities. Upper good recovery: no current problems related to brain injury.
Time frame: 7 days
Plan to share: Yes — The data will be available upon reasonable request from principle investigator
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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Tanta University