Dexmedetomidine Versus Midazolam for Facilitating Extubation
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The purpose of this randomized, double-blind study is to evaluate the utility, safety, and
      cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical
      intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing.
      Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine
      therapy and qualifying for daily awakenings will be randomized in a double-blind manner to
      receive additional midazolam or dexmedetomidine.
    

Detailed description: 
      This study is unique because midazolam or dexmedetomidine will be added, in a blinded
      fashion, to existing sedation and analgesia in an effort to decrease or possibly discontinue
      these therapies.

      Objectives:

      The objectives of this study are to determine if transitioning conventional sedation to
      dexmedetomidine safely facilitates tracheal extubation after study initiation; alters the
      amounts of sedative and analgesic agents required after study initiation; influences the
      levels of sedation and analgesia; alters the adverse event profile (neurologic, hemodynamic,
      or gastrointestinal) during and after discontinuing sedation; and impacts the total cost of
      sedation during and after discontinuing sedation.

      Hypothesis 1: Transitioning conventional sedation to dexmedetomidine expedites tracheal
      extubation to shorten ventilator time.

      Specific Aim 1: Comparatively determine the time from study initiation to tracheal extubation
      with midazolam and dexmedetomidine when the practice of daily awakenings is used.

      Hypothesis 2: Transitioning conventional sedation to dexmedetomidine reduces the doses of
      conventional sedatives and analgesics while maintaining equivalent levels of sedation and
      analgesia and not incurring adverse events.

      Specific Aim 2a: Comparatively determine the hourly, daily, and cumulative doses of
      conventional sedatives and analgesics from study initiation to sedation discontinuation with
      midazolam and dexmedetomidine when the practice of daily awakenings is used.

      Specific Aim 2b: Comparatively evaluate the quality of sedation and analgesia of midazolam
      and dexmedetomidine by determining the proportion of Riker sedation scores at 3 - 4 (desired
      level of sedation) and ≤ 2 or ≥ 5 (undesired levels of sedation) and the proportion of Pain
      Assessment Behavioral Scores (PABS) ≤ 3 (comfortable) and ≥ 4 (pain).

      Specific Aim 2c: Comparatively evaluate sedation-related adverse effects (neurologic,
      hemodynamic, or gastrointestinal) of midazolam and dexmedetomidine when the practice of daily
      awakenings is used.

      Hypothesis 3: Transitioning conventional sedation to dexmedetomidine increases the cost of
      administering sedation but minimizes the incidental costs associated with sedation to
      counterbalance and possibly reduce the total cost of sedation (sum of administration costs
      and incidental costs).

      Specific Aim 3a: Comparatively determine the hourly, daily, and cumulative administration
      costs of midazolam and dexmedetomidine when the practice of daily awakenings is used.

      Specific Aim 3b: Comparatively determine the hourly, daily, and cumulative incidental costs
      of conventional sedatives and dexmedetomidine; including neurologic dysfunction,
      antipsychotic requirements, cardiovascular dysfunction, constipation or ileus, differences in
      times to ventilator discontinuation, personnel time, and patient transfer from the ICU after
      sedation discontinuation.
    

Intervention name(s): Midazolam; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4); Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
Other intervention name(s): Versed; Precedex
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; Mechanical ventilation