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

NCT ID: NCT06870370

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2025-09-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Propranolol group

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

Group Type: EXPERIMENTAL

propranolol

Intervention Type: DRUG

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

normal saline IV group

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

Group Type: PLACEBO_COMPARATOR

normal saline IV

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

normal saline IV

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

Intervention Type: DRUG

Other Intervention Names

Experimental group; control group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Huda Talaat Ibrahim Elkallaf

Resident of Emergency Medicine and Traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huda Elkallaf, Resident

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, , Egypt

Countries

Egypt

Central Contacts

Huda Elkallaf, Resident

Role: CONTACT

hoda171661_pg@med.tanta.edu.eg

022 0 10 96213750

Huda Elkallaf, Resident

Role: CONTACT

Facility Contacts

Huda Elkallaf, Resident

Role: primary

hoda171661_pg@med.tanta.edu.eg

+20 10 96213750

Other Identifiers

36264MS291/8/23

Identifier Type: -

Identifier Source: org_study_id