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

Tanta University

Status and phase: Not yet enrolling; Phase 3

Conditions: Mortality; Traumatic Brain Injury (TBI) Patients; Intracranial Pressure; Intensive Care Unit

Treatments: Drug: normal saline IV; Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT06870370

36264MS291/8/23

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Propranolol group

Experimental group

Description:

This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days.

Treatment:

Drug: propranolol

normal saline IV group

Placebo Comparator group

Description:

This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

Treatment:

Drug: normal saline IV