Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients

• Status: Suspended
• Trial end date: 2021-09-16
• Target enrollment: 0
• Participant gender: All

Summary

Serial transcranial Doppler (TCD) exams in healthy volunteers and in animal models showed a strong linear relationship between middle cerebral artery (MCA) flow velocity (FV) and dexmedetomidine infusion. The concomitant elevation of pulsatility index (PI) indicates vasoconstriction of the cerebral vasculature as the most profound underlying mechanism.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Dexmedetomidine; Propofol

Criteria

Inclusion Criteria:

• Adult trauma patients (18-50 years old, ASA I-II).

• With and without mild TBI.

• Mild traumatic brain injury will include; brain edema, brain contusion, fracture base, fissure fracture and depressed fracture.

• The severity of traumatic brain injury will be defined as mild based on basal Glasgow Coma Scale and basal Computerized tomography scanning.

• Requirements of endotracheal intubation, mechanical ventilation and light to moderate sedation because of associated abdominal or chest traumatic injuries.

• The sedation needed should of an estimated duration not less than 24h.

• Baseline hemodynamic parameters within the normal range.

• Baseline middle cerebral artery flow velocity within the normal range.

Exclusion Criteria:

• Severe traumatic brain injury, subarachnoid hemorrhage and Intra-cerebral hemorrhage.

• Spinal cord injury.

• Hemodynamically unstable patients and patients on inotropes.

• Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator.

• Patients with hepatic or renal impairment.

• Pregnant females.

• Patients who are incarcerated.