Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Overview

The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.

Full Title of Study: “A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2008

Detailed Description

The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.

Interventions

  • Drug: Dexmedetomidine
    • in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
  • Drug: Propofol
    • in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)

Arms, Groups and Cohorts

  • Active Comparator: Precedex-Propofol
    • Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
  • Active Comparator: Propofol- Precedex
    • Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.

Clinical Trial Outcome Measures

Primary Measures

  • Lactate/Pyruvate (L/P)Ratio
    • Time Frame: 1 hour
    • L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.

Participating in This Clinical Trial

Inclusion Criteria

  • primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke – Must require (be on) mechanical ventilation – must require (have in place) intracranial pressure (ICP) monitoring – must require (be receiving) continuous IV sedation Exclusion Criteria:

  • Bleeding diathesis – Glasgow Coma Scale (GCS) < 5 with fixed pupils – Pregnant – elevated ICP that requires deep sedation – pulmonary instability – Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium – allergy to propofol or precedex – status epilepticus – current neuromuscular blockade

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Carmelo Graffagnino
  • Collaborator
    • Hospira, now a wholly owned subsidiary of Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Carmelo Graffagnino, Professor – Duke University
  • Overall Official(s)
    • Carmelo Graffagnino, MD, Principal Investigator, Duke University
    • DaiWai M Olson, PhD RN, Principal Investigator, Duke University

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