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

NCT04833218 | Unknown Early Phase 1

• 1 other identifier: 389:1/2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• catecholamine level on day 7

  measuring catecholamine level on day 7 after giving study drugs

  seven days

Secondary Outcomes (2)

• mean arterial blood pressure every 4 hours herat rate every 4 hours temperature every 4 hours respiratory rate every 4 hours

  7 days

• Glascow coma scale

  7 days

Study Arms (3)

propranolol group

ACTIVE COMPARATOR

we will give propranolol 40 milligram tablet twice daily in orogastric or nasogastric tube

Drug: Propranolol

propranolol clonidine

ACTIVE COMPARATOR

we will give propranolol 20 milligram tablet twice daily and clonidine 150 microgram tablet twice daily in orogatric or nasogastric tube

Drug: Propranolol

control group

NO INTERVENTION

we will give conventional treatment, no propranolol nor clonidine

Interventions

Propranolol DRUG

Test of catecholamines level in moderate traumatic brain injury

Also known as: Clonidine

propranolol clonidine; propranolol group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty Of Medicine

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol; Clonidine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amany Khairy, MD

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 6, 2021
• Study Start: January 31, 2020
• Primary Completion: June 22, 2021
• Study Completion: July 22, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-01

Locations

EG (1)