Comparison of Time to Extubation Using Sugammadex or Neostigmine
Condition: Neuromuscular Blockade; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective blinded randomized clinical trial to compare time to extubation using
      Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular
      blockade agents in an outpatient bronchoscopy suite.
    

Detailed description: 
      This research study will have the design of a blinded randomized clinical trial. The
      pharmacist will be blinded to the study medication given. The anesthesia provider cannot be
      blinded because he/she will need to determine the proper dose and timing of the neuromuscular
      blocker reversal medication (the study medications) given at the end of the procedure. The
      study will recruit 80 patients coming to Temple University Hospital for an outpatient
      bronchoscopy biopsy procedure that requires general anesthesia with neuromuscular blockade.
      Rocuronium will be the neuromuscular blockade medication given in this study. Inclusion
      criteria for these patients will include those age >18 who have a diagnosis of chronic
      obstructive pulmonary disease (COPD) and/or idiopathic lung disease (ILD) and who require
      medical treatment for the same; these patients will have American society of anesthesiology
      physical status (ASA PS) 3-4 based on their pulmonary disease alone.The patients will then be
      randomly assigned to one of two study arms (40 per arm). Patients in one arm of the study
      will receive Sugammadex and patients in the other arm will receive neostigmine/glycopyrrolate
      for reversal of neuromuscular blockade. Due to the nature of bronchoscopy for biopsy, the
      depth of anesthesia at the end of the case will be difficult to predict; the length of the
      cases may vary some (although most will be approximately one hour), and patients' metabolism
      of neuromuscular blocking agents is very much dependent on their personal medication regimens
      and liver function. Each patient's depth of neuromuscular blockade will be followed using the
      TwitchView monitor, a commercially available, an electromyography (EMG) based monitor. The
      TwitchView measures muscle response to delivered electrical stimuli (2Hz) which are sent in
      sets of 4X0.5 seconds apart (most commonly). The muscles controlled by the ulnar nerve will
      be followed during this study. Return of muscle strength after reversal agents are given is
      considered complete when the ratio of the strength of the response to the fourth electrical
      stimulus to the first stimulus is 0.9. Multiple time points will be recorded, including train
      of four measurement (TOF) every 5 minutes during the procedure, time and TOF at the end of
      the procedure, time of reversal medication dosing, time of TOF>0.9 and time of extubation.
      Reversal medication will be given as soon as each patient's procedure is complete and the
      patient meets appropriate criteria for reversal for each respective medication. Comparison of
      the data from the two arms of the study will then be made.
    

Intervention name(s): neostigmine/glycopyrrolate; sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): neuromuscular blockade reversal agents; neuromuscular blockade reversal agent
Other intervention name(s): prostigmin/robinul; Bridion
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medication
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nondepolarizing neuromuscular blockade; sugammadex; bronchoscopy; outpatient; lung disease