Beta Blocker Effects in Traumatic Brain Injury

Menoufia University

Status and phase: Completed; Phase 4

Conditions: Trauma, Brain

Treatments: Drug: Saline; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT05195996

2/2021ANESTH-4

Details and patient eligibility

About

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.

Full description

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups.

Parameters assessment:

• Length of ICU stay
• Length of total hospital stay
• CT scan to exclude another intracranial hemorrhage or increase in hemorrhage
• Functional status will be assessed using the GCS
• Hemodynamic data ( bl.p / hr )
• Crystalloid volume that patient need in 24h
• Mortality rate

Enrollment: 40 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• GCS preoperative >10
• Abbreviated Injury Scale (AIS) >3
• Length stay in ICU >48 h

Exclusion criteria

• Hypersensitivity to propranolol
• Asthmatic patient
• COPD
• History of smoking
• Any cardiac problems eg: ( heart failure or HB )
• pheochromocytoma
• Pregnant patient
• Length stay <48h
• Death within 48 h of admission
• Patient who previously received any beta blocker at home.
• Symptomatic Bradycardia <60 b/m (sick sinus syndrome)
• Hemodynamic unstable patients

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

beta blocker

Active Comparator group

Description:

Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours

Treatment:

Drug: Propranolol

placebo

Placebo Comparator group

Description:

Will be given normal saline 10 ml every 6 hours for 48 hours

Treatment:

Drug: Saline