Combining Propranolol and Gabapentin for Managing Symptoms in Traumatic Brain Injury
Role of Combined Therapy of Propranolol and Gabapentin in Paroxysmal Sympathetic Hyperactivity in Traumatic Brain Injury at Emergency Intensive Care Unit
This study is testing if combining two medications, propranolol and gabapentin, can help people with traumatic brain injury manage their symptoms better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 2 sites (Zagazig and 1 other locations) |
| Trial ID | NCT05427474 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a combined therapy using propranolol and gabapentin to manage paroxysmal sympathetic hyperactivity (PSH) in patients with traumatic brain injury (TBI). PSH is characterized by severe sympathetic nervous system overactivity, leading to various complications that can worsen patient outcomes. The study will enroll ICU patients with moderate to severe TBI and monitor the impact of the treatment on PSH symptoms and overall recovery. The approach aims to reduce the frequency and severity of PSH episodes, potentially improving the prognosis for TBI patients.
Who should consider this trial
Good fit: Ideal candidates for this study are ICU patients with moderate to severe traumatic brain injury, as indicated by their Glasgow Coma Scale scores.
Not a fit: Patients with pre-existing brain dysfunction, obstructive lung disease, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes and quality of life for patients suffering from traumatic brain injury.
How similar studies have performed: While the specific combination of propranolol and gabapentin for PSH in TBI is novel, similar approaches targeting sympathetic overactivity have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • ICU patients with moderate (GCS 9-12) to severe (GCS \<9) traumatic brain injury . Exclusion Criteria: * Pre-existing brain dysfunction . * History of allergy to any of the combined drug therapy ( propranolol or gabapentine ) . * History of obstructive lung disease . * History of heart disease . * Hypotension at admission of ICU. * Bradycardia . * Hypertension
Where this trial is running
Zagazig and 1 other locations
- Zagazig University Hospitals — Zagazig, Egypt (Active_not_recruiting)
- Zagazig University — Zagazig, Egypt (Recruiting)
Study contacts
- Principal investigator: Essamedin Negm, MD — Zagazig University
- Study coordinator: Essamedin Negm, MD
- Email: alpherdawss@gmail.com
- Phone: 0201098123058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.