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

NCT05340803 | Unknown Phase 3

• 1 other identifier: ONSD for TBI patients
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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 methds. One of these noninvasive methods is bedside measurement of optic nerve sheath diameter (ONSD) by ocular ultrasonography

Conditions

TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (1)

• Optic nerve sheath diameter (ONSD) changes by using ultrasound

  ONSD is an indicator for changes in intracranial pressure in response to sedation with midazolam alone versus combination with dexmedetomidine or magnesium sulfate which group will show better control of the increased intracranial pressure to prevent secondary brain insults. ONSD of 5.8mm was used as cutoff point for identifying ICP above 20 mmHg.

  up to 24 hours

Study Arms (3)

Group A

ACTIVE COMPARATOR

Sedation by midazolam alone

Radiation: Ultrasonograghic optic nerve sheath diameter US-ONSD; Drug: midazolam

Group B

ACTIVE COMPARATOR

Sedation by midazolam and dexmedetomidine during the first 24 hours

Radiation: Ultrasonograghic optic nerve sheath diameter US-ONSD; Drug: midazolam; Drug: dexmedetomidine

Group C

ACTIVE COMPARATOR

Sedation by midazolam and magnesium sulfate during the first 24 hours

Radiation: Ultrasonograghic optic nerve sheath diameter US-ONSD; Drug: midazolam; Drug: magnesium sulfate

Interventions

Ultrasonograghic optic nerve sheath diameter US-ONSD RADIATION

To compare effect of sedation in 3 groups by follow up of intracranial pressure by US-ONSD

Group A; Group B; Group C

midazolam DRUG

midazolam

Group A; Group B; Group C

dexmedetomidine DRUG

dexmedetomidine

Group B

magnesium sulfate DRUG

magnesium sulfate

Group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Middle age patients ( 18- 45 years old).
• Sever TBI (GCS \< 8 and in need for mechanical ventilation).
• Stable hemodynamics

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Midazolam; Dexmedetomidine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Alshymaa Hassan Mohammed, Master

CONTACT

01067555351; Alshimaa.hassan@medicine.luxor.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each group will contain 36 patients by double-blind manner using numbered sealed envelopes and the main investigator responsible for measurement ONSD will not be informed about the drug or drugs used for each patient
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: To compare use of midazolam alone versus combination of midazolam with dexmedetomidine or magnesium sulfate in patients with sever TBI ( Glasgow Coma Scale \< 8 and in need for mechanical ventilation) as regards effect on ICP monitored by US-ONSD as the primary outcome and anti-inflammatory effect (neuroprotective effect) by measurement of serum IL-6 as a secondary outcome.

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 22, 2022
• Study Start: November 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-04