Beta Blocker Effects in Traumatic Brain Injury

March 16, 2023 updated by: mostafa saieed fahim mansour, Menoufia University

Beta Blocker Effects on Patients With Traumatic Brain Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 32511
        • Faculty of Medicine, University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: beta blocker
Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours
Drug: Propranolol
intravenous propranolol for case patients
Placebo Comparator: placebo
Will be given normal saline 10 ml every 6 hours for 48 hours
Drug: Saline
intravenous saline for placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 7 days
number of surviving in patients receiving propranolol and patients who did not receive any beta blocker
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 7 days
number of patient showing effect of beta blocker on TBI related to HR
7 days
icu stay
Time Frame: 7 days
number of patients were beta blocker in TBI affected on ICU and total hospital stay
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2021ANESTH-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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