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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04833218
Other study ID # 389:1/2020
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date January 31, 2020
Est. completion date July 22, 2021

Study information

Verified date January 2021
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date July 22, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Drug:
Propranolol
Test of catecholamines level in moderate traumatic brain injury

Locations

Country Name City State
Egypt Faculty Of Medicine Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary catecholamine level on day 7 measuring catecholamine level on day 7 after giving study drugs seven days
Secondary 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 7 days
Secondary Glascow coma scale measuring glascow coma scale twice daily between 9 and 12 and higher score means better outcome. 7 days
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