NCT06870370

Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI

Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

Detailed description

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.

Conditions

• Traumatic Brain Injury (TBI) Patients
• Intracranial Pressure
• Intensive Care Unit
• Mortality

Interventions

Type	Name	Description
DRUG	propranolol	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
DRUG	normal saline IV	This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

Timeline

• Start date: 2025-09-20
• Primary completion: 2025-09-20
• Completion: 2025-09-20
• First posted: 2025-03-11
• Last updated: 2025-03-11

Locations

1 site across 1 country: Egypt