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

April 3, 2021 updated by: Fatma Rabea Mohammed, Minia University
evaluation of the effect of Propranolol versus propranolol and clonidine on decreasing sympathetic hyperactivity after moderate traumatic brain injury

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Early Phase 1

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
      • Minya, Egypt, 61111
        • Faculty of medicine

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propranolol group
we will give propranolol 40 milligram tablet twice daily in orogastric or nasogastric tube
Drug: Propranolol
Test of catecholamines level in moderate traumatic brain injury
Other Names:
  • Clonidine
Active Comparator: propranolol clonidine
we will give propranolol 20 milligram tablet twice daily and clonidine 150 microgram tablet twice daily in orogatric or nasogastric tube
Drug: Propranolol
Test of catecholamines level in moderate traumatic brain injury
Other Names:
  • Clonidine
No Intervention: control group
we will give conventional treatment, no propranolol nor clonidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catecholamine level on day 7
Time Frame: seven days
measuring catecholamine level on day 7 after giving study drugs
seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean arterial blood pressure every 4 hours herat rate every 4 hours temperature every 4 hours respiratory rate every 4 hours
Time Frame: 7 days
measuring hemodynamics every 4 hours
7 days
Glascow coma scale
Time Frame: 7 days
measuring glascow coma scale twice daily between 9 and 12 and higher score means better outcome.
7 days

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Study Chair: Amany Khairy, MD, Professor

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)

January 31, 2020

Primary Completion (Anticipated)

June 22, 2021

Study Completion (Anticipated)

July 22, 2021

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

April 3, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 389:1/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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