CClinicalTrials.gg
CompletedNCT05195996Updated Mar 17, 2023

Beta Blocker Effects in Traumatic Brain Injury

A Phase 4 interventional study of Propranolol and Saline in Trauma, Brain, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Menoufia University · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 40 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    beta blocker

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

    Drug: Propranolol

  • Placebo comparator
    placebo

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

    Drug: Saline

Interventions

  • DrugPropranolol

    intravenous propranolol for case patients

  • DrugSaline

    intravenous saline for placebo

06

What researchers measure

Primary outcomes

  1. survival

    number of surviving in patients receiving propranolol and patients who did not receive any beta blocker

    Time frame: 7 days

Secondary outcomes

  1. heart rate

    number of patient showing effect of beta blocker on TBI related to HR

    Time frame: 7 days

  2. icu stay

    number of patients were beta blocker in TBI affected on ICU and total hospital stay

    Time frame: 7 days

07

Study locations

1 site
  • Faculty of Medicine, University Hospitals
    Shibīn Al Kawm, Menoufia 32511, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05195996
Lead sponsor
Menoufia University
Responsible party
mostafa saieed fahim mansour (lecturer, Menoufia University) — Principal investigator
First posted
Jan 19, 2022
Start date
Oct 1, 2021
Primary completion
Mar 31, 2022
Completion
May 31, 2022
Last update
Mar 17, 2023

Study contacts

mostafa f mansour, MD
principal investigator · Menoufia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion