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

Early Phase 1

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Propranolol

• Registration Number: NCT04833218
• Lead Sponsor: Minia University

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

Study Timeline

• Study Start: 2020-01-31
• Status Verified: 2021-01
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-04-03
• Last Update Submitted: 2021-04-03
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06
• Primary Completion: 2021-06-22
• Study Completion: 2021-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propranolol clonidine	Propranolol	we will give propranolol 20 milligram tablet twice daily and clonidine 150 microgram tablet twice daily in orogatric or nasogastric tube
propranolol group	Propranolol	we will give propranolol 40 milligram tablet twice daily in orogastric or nasogastric tube

Primary Outcome Measures

Name	Time	Method
catecholamine level on day 7	seven days	measuring catecholamine level on day 7 after giving study drugs

Secondary Outcome Measures

Name	Time	Method
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
Glascow coma scale	7 days	measuring glascow coma scale twice daily between 9 and 12 and higher score means better outcome.

Trial Locations

Locations (1)

Faculty Of Medicine; 🇪🇬 Minya, Egypt