Beta Blocker Effects in Traumatic Brain Injury

NCT ID: NCT05195996

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-05-31

Brief Summary

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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

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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

Conditions

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Trauma, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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beta blocker

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

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

intravenous propranolol for case patients

placebo

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

intravenous saline for placebo

Interventions

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Propranolol

intravenous propranolol for case patients

Intervention Type DRUG

Saline

intravenous saline for placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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mostafa saieed fahim mansour

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mostafa f mansour, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

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Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2/2021ANESTH-4

Identifier Type: -

Identifier Source: org_study_id

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