A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
Condition: Posterior Cervical Decompression and Fusion
Intervention: Sugammadex Injection [Bridion]; Placebo
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
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)
Masking description: This is a randomized blinded study where the administering anesthetist, surgeon and neurophysiologists will be blinded to the intervention.
Further, a blinded research assistant will perform assessment, data collection, and analysis of neurophysiology data attained.
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Motor Evoked Potentials, Spine surgery, Muscle relaxants

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients aged 18-80 years with American Society of Anesthesiologist (ASA)
             classification I-III undergoing cervical spine surgery in the prone position with
             intraoperative motor evoked potential monitoring.

          -  Operation time greater than 3 hours

        Exclusion Criteria:

          -  Allergy to propofol or documented egg allergy

          -  Known allergy to sugammadex

          -  Severe renal dysfunction (EGFR<30)

          -  British Research Medical Council (BRMC) motor grading <3 in any peripheral muscle
             group preoperatively. This is inability to move the muscle group against gravity.

          -  Surgical requirement of strict muscle relaxation for surgical exposure

          -  Lack of informed consent

          -  Pregnancy

          -  Loss of MEP signals during washout period (or intraoperative spinal cord injury
             resulting in irreversible loss of MEP)