Back to resultsPropranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Propranolol
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury
Eligibility Criteria
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
Sites / Locations
- Faculty Of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
propranolol group
propranolol clonidine
control group
Arm Description
we will give propranolol 40 milligram tablet twice daily in orogastric or nasogastric tube
we will give propranolol 20 milligram tablet twice daily and clonidine 150 microgram tablet twice daily in orogatric or nasogastric tube
we will give conventional treatment, no propranolol nor clonidine
Outcomes
Primary Outcome Measures
catecholamine level on day 7
measuring catecholamine level on day 7 after giving study drugs
Secondary Outcome Measures
mean arterial blood pressure every 4 hours herat rate every 4 hours temperature every 4 hours respiratory rate every 4 hours
measuring hemodynamics every 4 hours
Glascow coma scale
measuring glascow coma scale twice daily between 9 and 12 and higher score means better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04833218
Brief Title
Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury
Official Title
Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
June 22, 2021 (Anticipated)
Study Completion Date
July 22, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
evaluation of the effect of Propranolol versus propranolol and clonidine on decreasing sympathetic hyperactivity after moderate traumatic brain injury
Detailed Description
measuring catecholamine levels after moderate traumatic brain injury after giving propranolol and clonidine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
propranolol group
Arm Type
Active Comparator
Arm Description
we will give propranolol 40 milligram tablet twice daily in orogastric or nasogastric tube
Arm Title
propranolol clonidine
Arm Type
Active Comparator
Arm Description
we will give propranolol 20 milligram tablet twice daily and clonidine 150 microgram tablet twice daily in orogatric or nasogastric tube
Arm Title
control group
Arm Type
No Intervention
Arm Description
we will give conventional treatment, no propranolol nor clonidine
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Clonidine
Intervention Description
Test of catecholamines level in moderate traumatic brain injury
Primary Outcome Measure Information:
Title
catecholamine level on day 7
Description
measuring catecholamine level on day 7 after giving study drugs
Time Frame
seven days
Secondary Outcome Measure Information:
Title
mean arterial blood pressure every 4 hours herat rate every 4 hours temperature every 4 hours respiratory rate every 4 hours
Description
measuring hemodynamics every 4 hours
Time Frame
7 days
Title
Glascow coma scale
Description
measuring glascow coma scale twice daily between 9 and 12 and higher score means better outcome.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany Khairy, MD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty Of Medicine
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury
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