Sedation of Ventilated Traumatic Brain Injury Patients With Midazolam Alone Versus Combination With Dexmedetomidine or Magnesium Sulfate; Monitored by Ultrasonograghic Optic Nerve Sheath Diameter

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In TBI, there is a strong correlation between increased ICP and bad outcome. So, appropriate monitoring can be the gold standard in management of TBI. ICP can be measured by invasive and noninvasive methds. One of these noninvasive methods is bedside measurement of optic nerve sheath diameter (ONSD) by ocular ultrasonography

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Dexmedetomidine; Magnesium Sulfate; Midazolam

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 .