MedTrace Logo

Role of Combined Therapy of Propranolol and Gabapentin in Paroxysmal Sympathetic Hyperactivity in Traumatic Brain Injury

NCT05427474 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-06-13

No results posted yet for this study

Summary

Paroxysmal sympathetic hyperactivity (PSH) is a syndrome that comprises a series of signs and symptoms reflecting exacerbated sympathetic activity, including arterial hypertension, fever, tachycardia, generalized perspiration, anomalous motor activity (dystonia, muscle stiffness, extension), tachypnea, mechanical ventilator maladjustment, hypoxemia, hypercapnia, and hyperglycemia. PSH episodes can be intense and prolonged and can occur several times a day and all of these can lead to secondary brain damage and are the main causes of a poor prognosis. Paroxysmal sympathetic hyperactivity also induces a hypermetabolic state with hypercatabolism and inflammation and increases vulnerability to infections, sepsis, and weight loss which in turn are associated with increased morbidity, longer hospital stay, and slower recovery. The marked and sustained increase in catecholamine levels predisposes to the development of cardiomyopathy, lung edema, arrhythmias, and cardiac and multisystemic dysfunction.

The reported incidence of paroxysmal sympathetic hyperactivity ranges from 8% to 33% and has no particular age or gender predilection. 80% of these syndrome incidents developed with traumatic brain injury.

Conditions

Interventions

DRUG

Propranolol , gabapentin

The combined therapy of propranolol and gabapentine can prevent the occurrence of paroxysmal sympathetic hyperactivity in traumatic brain injury patients and improve the clinical outcomes in emergency ICU.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Essamedin Negm, MD · Zagazig University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-09-30
Completion
2023-10-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05427474 on ClinicalTrials.gov