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

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

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.

Study Overview

• Status: Suspended
• Conditions: Sedation
• Intervention / Treatment: Drug: 0.2-0.7 mcg/kg/h dexmedetomedine infusion.; Drug: 10-70 mcg/kg/h propofol infusion.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut Governorate
    • Assiut, Assiut Governorate, Egypt, 715715
      • Assiut university main hospital, Trauma ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DEX I; Trauma Patients without TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.	Drug: 0.2-0.7 mcg/kg/h dexmedetomedine infusion.; patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.; Other Names: Precedex
Active Comparator: DEX II; Trauma Patients with TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.	Drug: 0.2-0.7 mcg/kg/h dexmedetomedine infusion.; patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.; Other Names: Precedex
Active Comparator: Propofol I; Trauma Patients without TBI received 10-70 mcg/kg/h propofol infusion.	Drug: 10-70 mcg/kg/h propofol infusion.; Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.; Other Names: Deprivan
Active Comparator: Propofol II; Trauma Patients with TBI received 10-70 mcg/kg/h propofol infusion.	Drug: 10-70 mcg/kg/h propofol infusion.; Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.; Other Names: Deprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdelghaffar, MD, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Anticipated): September 16, 2021
• Study Completion (Anticipated): September 16, 2021

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 17200002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No