NCT03285165

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

Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients With and Without Traumatic Brain Injury.

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Available clinical evidence on the use of dexmedetomidine sedation in neurosurgical and neurocritical care is limited and no definite conclusion can be drawn. There is a need for The use of dexmedetomidine might be a useful adjunct in clinical situations when the increase in CBF could be detrimental such as vasogenic cerebral edema (i.e., TBI, large brain tumors). However, dexmedetomidine sedation is questionable in patients with subarachnoid hemorrhage and acute stroke, since the associate drop in arterial pressure could worsen the coexisting increase in circulating catecholamines and massive sympathetic outflow. Further high-quality RCTs to evaluate the use of dexmedetomidine as a sedative agent both in general ICU patients and in patients with TBI. Transcranial Doppler (TCD) is a simple noninvasive bedside tool to assess the cerebral blood flow pattern. The new development of transcranial color Doppler with angle correction option helps to improve the sensitivity of test results. TCD can assess the evolution of CBF alterations and possibly cerebral autoregulation performance and ICP estimation in patients presenting with cerebral pathology.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	0.2-0.7 mcg/kg/h dexmedetomedine infusion.	patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.
DRUG	10-70 mcg/kg/h propofol infusion.	Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.

Timeline

• Start date: 2017-09-14
• Primary completion: 2021-09-16
• Completion: 2021-09-16
• First posted: 2017-09-15
• Last updated: 2020-07-14

Locations

1 site across 1 country: Egypt