Beta Blocker Effects in Traumatic Brain Injury

Phase 4

Completed

• Conditions: Trauma, Brain
• Interventions: Drug: Saline; Drug: Propranolol

• Registration Number: NCT05195996
• Lead Sponsor: Menoufia University

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Primary Completion: 2022-03-31
• Study Completion: 2022-05-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Saline	Will be given normal saline 10 ml every 6 hours for 48 hours
beta blocker	Propranolol	Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours

Primary Outcome Measures

Name	Time	Method
survival	7 days	number of surviving in patients receiving propranolol and patients who did not receive any beta blocker

Secondary Outcome Measures

Name	Time	Method
heart rate	7 days	number of patient showing effect of beta blocker on TBI related to HR
icu stay	7 days	number of patients were beta blocker in TBI affected on ICU and total hospital stay

Trial Locations

Locations (1)

Faculty of Medicine, University Hospitals; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt