Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury

NCT ID: NCT04833218

Last Updated: 2021-04-06

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-07-22

Brief Summary

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evaluation of the effect of Propranolol versus propranolol and clonidine on decreasing sympathetic hyperactivity after moderate traumatic brain injury

Detailed Description

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measuring catecholamine levels after moderate traumatic brain injury after giving propranolol and clonidine

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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propranolol group

we will give propranolol 40 milligram tablet twice daily in orogastric or nasogastric tube

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Test of catecholamines level in moderate traumatic brain injury

propranolol clonidine

we will give propranolol 20 milligram tablet twice daily and clonidine 150 microgram tablet twice daily in orogatric or nasogastric tube

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Test of catecholamines level in moderate traumatic brain injury

control group

we will give conventional treatment, no propranolol nor clonidine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Propranolol

Test of catecholamines level in moderate traumatic brain injury

Intervention Type DRUG

Other Intervention Names

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Clonidine

Eligibility Criteria

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Inclusion Criteria

* GCS on admission between 9 and 12 age 18 up to 60 years both sexes

Exclusion Criteria

* history of heart disease, cardiac arrhythmia and myocardial infarction diagnosis ofpreexisting brain dysfunction. impending brain herniation and craniotomy diagnosis of spinal cord injuries. diagnisis of severe liver and renal disease current use of beta blocker and or alpha agonist current using of intravenous vasopressor contraindication to enteral feeding and can not swallow pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Rabea Mohammed

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amany Khairy, MD

Role: STUDY_CHAIR

Professor

Locations

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Faculty Of Medicine

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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389:1/2020

Identifier Type: -

Identifier Source: org_study_id

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