A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
Condition: Posterior Cervical Decompression and Fusion
Study type: Interventional
Phase: Phase 4

Summary: 
      Intraoperative monitoring of the motor evoked potentials has been shown to be both a
      sensitive and specific indicator for detecting intraoperative neurological injuries during
      spine surgery.(Fehlings, Brodke et al. 2010) It is utilized whenever there is risk for injury
      of nerve roots or the spinal cord during the procedure.

      Anesthetic agents, especially the inhaled volatile anesthetics and muscle relaxants, are
      con-founders for motor evoked potential monitoring as they have deleterious effects on the
      amplitude of motor evoked potentials.(Sekimoto, Nishikawa et al. 2006) Hence, total
      intravenous anesthesia with no intraoperative muscle relaxants, are the standard anesthetic
      technique for these surgeries.

      Muscle relaxants are usually required during the induction of anesthesia and endotracheal
      intubation of larynx. Current practice is to wait for the resolution of residual
      neuromuscular blockade before the motor evoked potential recordings (MEP) are initiated and
      this makes it difficult to assess if there was any neurological injury associated with
      positioning of the patient. A previous case series has shown that reversal of muscle relaxant
      can improve the amplitude of MEPs.(Batistaki, Papadopoulos et al. 2012) The aim of this study
      is to perform a randomized controlled trial to study the changes in motor evoked potential
      amplitudes comparing sugammadex and placebo.
    

Detailed description: 
      Motor evoked potential monitoring is a well-established and safe intervention to assist in
      prevention of intraoperative injury during spine surgery.(Schwartz, Sestokas et al. 2011)
      Patients with cervical myelopathy often present with neurological deficits and recording of
      the motor evoked potentials are often challenging in these patients. In addition, anesthetic
      agents especially muscle relaxants can abolish the motor response making it difficult to know
      when the baseline MEP can be recorded.

      The usual anesthetic practice for patients undergoing posterior cervical spine surgery is to
      administer muscle relaxation to aid intubation at the start of the case . The neuromuscular
      blockade is then allowed to wear off and the neurophysiologist will attempt to record their
      baseline motor evoked potentials during or just prior to surgical exposure.

      The issues with this current technique are;

        1. Patients cannot be monitored for neurological changes during their transfer into the
           prone position

        2. There is likely residual neuromuscular blockade decreasing the amplitude of motor evoked
           potentials.

      Investigators plan to perform a randomized controlled cross-over trial comparing the change
      in MEP amplitudes with administration of sugammadex or placebo. This will be performed on at
      risk patients (e.g. cervical myelopathy) undergoing posterior cervical spine surgery where
      MEPs can be more difficult to attain but of higher utility.

      The purpose of this study is to determine if reversal of residual neuromuscular blockade with
      Sugammadex can increase the amplitude of the motor evoked potentials.
    

Intervention name(s): Sugammadex Injection [Bridion]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study participants will receive 10 ml syringe containing Sugammadex (2mg/kg) in the first phase followed by Placebo 10 ml syringe containing of 0.9% of normal saline in the second phase.; The study participants will receive Placebo 10 ml syringe containing of 0.9% of normal saline in the first phase followed by 10 ml syringe containing Sugammadex (2mg/kg) in the second phase.
Other intervention name(s): Sugammadex; Normal Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized controlled crossover trial comparing the change in MEP amplitudes with administration of sugammadex or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Motor Evoked Potentials, Spine surgery, Muscle relaxants