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

Sedation Clinical Trial

— DEXSEDATION  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03285165
• Other study ID #: 17200002
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: September 14, 2017
• Est. completion date: September 16, 2021

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: September 16, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• 0.2-0.7 mcg/kg/h dexmedetomedine infusion.
patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.
• 10-70 mcg/kg/h propofol infusion.
Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.

Locations

Country	Name	City	State
Egypt	Assiut university main hospital, Trauma ICU	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle cerebral artery flow velocity	1. Right and left middle cerebral artery (MCA) will be measured via trans-temporal window and the depth of insinuation will be between 30-60 mm with the subject's head in neutral position. Mean values of simultaneously measured invasive blood pressure recordings and the outer envelope of time averaged MCA flow velocity (FV) recordings during ten consecutive cardiac cycles	24 hours