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

NCT03285165 | Suspended Phase 2 DMC

• 1 other identifier: 17200002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

DEX I

ACTIVE COMPARATOR

Trauma Patients without TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.

Drug: 0.2-0.7 mcg/kg/h dexmedetomedine infusion.

DEX II

ACTIVE COMPARATOR

Trauma Patients with TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.

Drug: 0.2-0.7 mcg/kg/h dexmedetomedine infusion.

Propofol I

ACTIVE COMPARATOR

Trauma Patients without TBI received 10-70 mcg/kg/h propofol infusion.

Drug: 10-70 mcg/kg/h propofol infusion.

Propofol II

ACTIVE COMPARATOR

Trauma Patients with TBI received 10-70 mcg/kg/h propofol infusion.

Drug: 10-70 mcg/kg/h propofol infusion.

Interventions

0.2-0.7 mcg/kg/h dexmedetomedine infusion. DRUG

patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.

Also known as: Precedex

DEX I; DEX II

10-70 mcg/kg/h propofol infusion. DRUG

Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.

Also known as: Deprivan

Propofol I; Propofol II

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university main hospital, Trauma ICU

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hala S Abdelghaffar, MD

  Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 15, 2017
• Study Start: September 14, 2017
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)