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

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ClinicalTrials.gov Identifier: NCT03285165
Recruitment Status : Unknown
Verified September 2017 by Hala Saad Abdel-Ghaffar, Assiut University.
Recruitment status was:  Recruiting
First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University

Brief 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.

Condition or disease Intervention/treatment Phase
Sedation Drug: 0.2-0.7 mcg/kg/h dexmedetomedine infusion. Drug: 10-70 mcg/kg/h propofol infusion. Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: this study will be accomplished to investigate the effect of dexmedetomidine sedation on the cerebral blood flow in intubated mechanically ventilated trauma patients with and without traumatic brain injury, in comparison with propofol.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients With and Without Traumatic Brain Injury.
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Deprivan




Primary Outcome Measures :
  1. Middle cerebral artery flow velocity [ Time Frame: 24 hours ]
    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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285165


Contacts
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Contact: Hala S Abdelghaffar, MD 01003812011 ext +2088 hallasaad@yahoo.com
Contact: Omnia H Thabet, MBBCH 01095029249 ext +2088 dr_omnia_h@yahoo.com

Locations
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Egypt
Assiut university main hospital, Trauma ICU Recruiting
Assiut, Assiut governorate, Egypt, 715715
Contact: Hala S Abdelghaffar, MD    01003812011 ext +2 088    hallasaad@yahoo.com   
Contact: Omnia H Thabet, MBBCH    01095029249 ext +2 088    dr_omnia_h@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Hala S Abdelghaffar, MD Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

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Responsible Party: Hala Saad Abdel-Ghaffar, Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut University
ClinicalTrials.gov Identifier: NCT03285165     History of Changes
Other Study ID Numbers: 17200002
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action