Efficacy and Safety of a Single Syringe Total Intravenous Anesthesia With Propofol and Remifentanil: A Prospective Cohort Study
Condition: Anesthesia
Study type: Observational

Summary: 
      The purpose of this prospective observational study was to evaluate the efficacy and safety
      of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a
      processed EEG (pEEG) index within the recommended range for general anesthesia for the
      duration of the maintenance anesthetic. The primary outcome measure for safety was
      intraoperative administration of vasopressors. We hypothesized that the pEEG index would be
      within the recommended range for over 90% of the duration of the maintenance anesthetic. We
      hypothesized that vasopressor use would be consistent with other anesthetic types using
      potent inhaled agents.
    

Detailed description: 
      Total intravenous anesthesia (TIVA) is a commonly used general anesthetic. Propofol and
      remifentanil is a common drug combination used in TIVA and is a safe and efficacious method
      of anesthesia in pediatric and adult patients.[1-7] A typical TIVA method is to administer
      each drug using a separate syringe pump. Another approach to TIVA is to use a single syringe
      pump containing propofol and remifentanil. This approach is considered off-label as neither
      drug has been approved by a national or international regulatory agency to be used in a
      single syringe.

      The efficacy and safety of single syringe TIVA has not yet been evaluated. At a single
      university hospital center, single syringe TIVA with propofol and remifentanil has been used
      for over 15 years for a variety of procedures. A common combination of propofol and
      remifentanil in a single syringe is propofol 10 mg/ml and remifentanil 20 mcg/ml.

      A preliminary retrospective analysis of electronic medical records (Epic Hyperspace
      Electronic Medical Record, Epic Systems Corporation, Verona, Wisconsin) from May of 2014 to
      June of 2019 identified 21,985 procedures using single syringe TIVA. (unpublished data) This
      retrospective analysis, was used to identify adverse events, which included: awareness during
      surgery, significant vasopressor use, replacement of the single syringe TIVA with an inhaled
      anesthetic, and patient injury or death. This analysis was limited by possible clinician
      underreporting of vasopressor use, changes in TIVA infusion rates, and awareness events.

      The purpose of this prospective observational study was to evaluate the efficacy and safety
      of single syringe TIVA with propofol and remifentanil. The primary outcome for efficacy was a
      processed EEG (pEEG) index within the recommended range for general anesthesia for the
      duration of the maintenance anesthetic. The primary outcome measure for safety was
      intraoperative administration of vasopressors. We hypothesized that the pEEG index would be
      within the recommended range for over 90% of the duration of the maintenance anesthetic. We
      hypothesized that vasopressor use would be consistent with other anesthetic types using
      potent inhaled agents.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to an orthopedic surgery center for elective surgery.