Beta Blocker Effects in Traumatic Brain Injury

Trauma, Brain Clinical Trial

Official title:

Beta Blocker Effects on Patients With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195996
• Other study ID #: 2/2021ANESTH-4
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Trauma, Brain

Intervention

Drug:
• Propranolol
intravenous propranolol for case patients
• Saline
intravenous saline for placebo

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, University Hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	number of surviving in patients receiving propranolol and patients who did not receive any beta blocker	7 days
Secondary	heart rate	number of patient showing effect of beta blocker on TBI related to HR	7 days
Secondary	icu stay	number of patients were beta blocker in TBI affected on ICU and total hospital stay	7 days