NCT05427474

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

Status unknown Phase 3 Last updated 13 June 2023

What this trial tests

Phase 3 trial testing Propranolol , gabapentin in Traumatic Brain Injury in 90 participants. Status unknown.

Timeline

1 December 2022

Primary endpoint
30 September 2023

31 October 2023

Quick facts

Lead sponsor	Zagazig University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	90
Start date	1 December 2022
Primary completion	30 September 2023
Estimated completion	31 October 2023
Sites	2 locations across Egypt

Drugs / interventions tested

• Propranolol , gabapentin — full drug profile →

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

Zagazig University

Who can join

Adults 18 to 65, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Propranolol monotherapy versus combined propranolol-gabapentin for prevention of paroxysmal sympathetic hyperactivity after moderate-severe traumatic brain injury: a randomized controlled trial.
   Negm EM, Gouda AM, Khatab MEM, Youssef EME, et al · · 2026 · PMID 42104241 · DOI 10.1186/s12871-026-03802-2