Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Condition: Incomplete Reversal of Neuromuscular Block
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare patient recovery measures after reversal of neuromuscular blockade
      with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle
      strength, time to extubation and quality of recovery in the post anesthesia care unit.
    

Detailed description: 
      Sugammadex has been shown to have a faster onset and more reliable reversal of neuromuscular
      blockade when compared to neostigmine as measured by return of Train-of-four (TOF) ratio to
      >0.9. (Breuckmann, 2015) The investigator's hypothesis is that sugammadex will be associated
      with improved deep breathing as measured by incentive spirometry in the PACU. The
      investigators also hypothesize that patients reversed with sugammadex will have shorter times
      to extubation and better recovery profiles in the PACU as measured by strength, PACU
      discharge readiness and quality of recovery scores.

      Residual neuromuscular blockade after surgery can result in airway compromise, pulmonary
      complications, and possible need for reintubation and can be a negative experience for
      patients. Reintubation after surgery is currently a quality measure in NSQIP (National
      Surgery Quality Improvement Program) A TOF ratio of <0.9 has been identified as a marker of
      residual neuromuscular blockade in the PACU. (Farhan 2013) Several clinical trials have shown
      that reversal of neuromuscular blockade with sugammadex results in a faster and more reliable
      return to TOF ratio of >0.9 when compared to neostigmine. However most of these studies
      primarily report on TOF ratios. There are scant data on clinical outcomes after reversal with
      neostigmine versus sugammadex. Incentive spirometry is a clinically meaningful measurement of
      postoperative pulmonary function, i.e the ability to breath deeply, which minimizes
      atelectasis and risk of postoperative pneumonia.

      The investigators will compare recovery profiles of patients who have received sugammadex or
      neostigmine for reversal of neuromuscular blockade after surgery. The primary outcome will be
      incentive spirometry volumes after surgery as a measure of pulmonary function. The secondary
      measures include hand grip measured using a dynamometer, time to extubation, time to PACU
      discharge, time to sit independently, and quality of recovery 15 survey scores.

      This will be a single-center, prospective, randomized, assessor blinded, controlled trial.
      Patients will be randomized to either receive sugammadex or neostigmine for the reversal of
      neuromuscular blockade. The anesthesiologist will be unblinded to the study drug however the
      assessor in the PACU will be blinded.
    

Intervention name(s): Sugammadex; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): Sugammadex will be given for reversal of neuromuscular blockade.; Neostigmine will be given for reversal of neuromuscular blockade.
Other intervention name(s): Bridion; Prostigmine
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment