Status:
UNKNOWN
Sedation of Ventilated Traumatic Brain Injury Patients With Midazolam Alone Versus Combination With Dexmedetomidine or Magnesium Sulfate; Monitored by Ultrasonograghic Optic Nerve Sheath Diameter
Lead Sponsor:
Assiut University
Conditions:
TBI (Traumatic Brain Injury)
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief 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 m...
Detailed Description
In the previous few years, agreat evidence has established for efficiency of dexmedetomidine (DEX) in management of TBI. Dexmedetomidine is a highly selective alpha-2 receptor agonist, its major sympa...
Eligibility Criteria
Inclusion
- Middle age patients ( 18- 45 years old).
- Sever TBI (GCS \< 8 and in need for mechanical ventilation).
- Stable hemodynamics
Exclusion
- Age: younger than 18 or older than 45 years old.
- Mild and moderate TBI (GCS \> 8).
- Shocked and hypoxic patients.
- 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).
- 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.
- 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).
- 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 .
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05340803
Start Date
November 1 2022
End Date
December 1 2025
Last Update
April 22 2022
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