Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT05340803
Eligibility Criteria:
Inclusion Criteria:
1. Middle age patients ( 18- 45 years old).
2. Sever TBI (GCS \< 8 and in need for mechanical ventilation).
3. Stable hemodynamics
Exclusion Criteria:
1. Age: younger than 18 or older than 45 years old.
2. Mild and moderate TBI (GCS \> 8).
3. Shocked and hypoxic patients.
4. Contraindications to dexmedetomidine as sever hypotension (mean arterial blood pressure \< 60 mmHg), sever bradycardia (heart rate \< 45 beat/min), and AV block in the group that will be sedated by midazolam and dexmedetomidine (group B).
5. Adverse effects of dexmedetomidine in group B and need to stop it as sever hypotension (mean arterial blood pressure \< 60 mmHg) , sever bradycardia (heart rate \< 45 beat/min), and atrial fibrillation.
6. Contraindications to magnesium sulfate as heart block, myocardial damage, hypermagnesemia and renal failure in the group that will be sedated by midazolam and magnesium sulfate (group C).
7. Manifestations of magensium toxicity in group C and need to stop infusion if urine output \< 80 mL in 4 hours, deep tendon reflexes are absent or serum magnesium level \> 3.5 mmol/L .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05340803
Study Brief:
Protocol Section:
NCT05340803