Clincosm LogoSign in Get a demo

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

Sponsor
Minia University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04833218
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
17.7
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Diagnostic
Official Title:
Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury
Actual Study Start Date :
Jan 31, 2020
Anticipated Primary Completion Date :
Jun 22, 2021
Anticipated Study Completion Date :
Jul 22, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. catecholamine level on day 7 [seven days]

      measuring catecholamine level on day 7 after giving study drugs

    Secondary Outcome Measures

    1. mean arterial blood pressure every 4 hours herat rate every 4 hours temperature every 4 hours respiratory rate every 4 hours [7 days]

      measuring hemodynamics every 4 hours

    2. Glascow coma scale [7 days]

      measuring glascow coma scale twice daily between 9 and 12 and higher score means better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty Of Medicine Minya Egypt 61111

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Study Chair: Amany Khairy, MD, Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatma Rabea Mohammed, assistant lecturer, Minia University
    ClinicalTrials.gov Identifier:
    NCT04833218
    Other Study ID Numbers:
    • 389:1/2020
    First Posted:
    Apr 6, 2021
    Last Update Posted:
    Apr 6, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries
    Propranolol
    Clonidine

    Study Results

    No Results Posted as of Apr 6, 2021