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

Phase 3

Not yet recruiting

• Conditions: Traumatic Brain Injury (TBI) Patients; Intracranial Pressure; Intensive Care Unit; Mortality
• Interventions: Drug: propranolol; Drug: normal saline IV

• Registration Number: NCT06870370
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-09-20
• Primary Completion: 2025-09-20
• Study Completion: 2025-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients aged between 18and 65 years old
• Patients who have Severe traumatic brain injury
• Glascow outcome scale ≤ 8

Exclusion Criteria

• Patients have pre-existing heart disease.
• If there are contraindications to β blocker.
• penetrating traumatic brain injury.
• pre-injury brain dysfunction.
• β-blocker or α2-agonist use before trauma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol group	propranolol	This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days.
normal saline IV group	normal saline IV	This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

Primary Outcome Measures

Name	Time	Method
Mortality	7 days	Mortality in severe traumatic brain injury with usage of β blocker

Secondary Outcome Measures

Name	Time	Method
Glascow outcome scale extended	7 days	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt