Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: propranolol, normal saline IV.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury (TBI) Patients, Intracranial Pressure, Intensive Care Unit, Mortality. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury
Overview
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.
Interventions
- 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
Primary outcome measures
- Mortality [Time frame: 7 days]
Secondary outcome measures (1)
- Glascow outcome scale extended [Time frame: 7 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT06870370 · 36264MS291/8/23