A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo

Phase 4

Completed

Conditions: Posterior Cervical Decompression and Fusion

Interventions: Drug: Sugammadex Injection [Bridion]
Drug: Placebo

Registration Number: NCT03087513

Lead Sponsor: University Health Network, Toronto

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Initial Arm	Sugammadex Injection [Bridion]	The study participants will receive either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline).
Initial Arm	Placebo	The study participants will receive either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline).
Crossover Arm	Sugammadex Injection [Bridion]	The study participants will receive the study medication that was not given in the initial arm (either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline) .
Crossover Arm	Placebo	The study participants will receive the study medication that was not given in the initial arm (either Sugammadex (2 mg/kg in 10 ml 0.9% normal saline) or placebo (10 ml of 0.9% normal saline) .

Primary Outcome Measures

Name	Time	Method
Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes	Baseline and 3 minutes after the study intervention	Changes in the amplitude of the Motor Evoked Potentials from the baseline in the first dorsal interosseous muscle at 3 minutes in sugammadex group compared to placebo group

Secondary Outcome Measures

Name	Time	Method
MEPs Amplitude Changes in Both Sugammadex and Placebo Groups	Baseline to 6 minutes	Changes in the amplitude of the MEPs from the baseline in the first dorsal interosseous muscle at 6 minutes
Patient Movement	From 0 to 15 minutes	Number of patients moved and observed by the surgeon. From the study intervention to the surgeon observed patient movements
MEPs Amplitude Changes From Baseline at 9 Minutes	Baseline to 9 minutes	Comparison of changes in MEP amplitudes from baseline at 9 minutes between sugammadex and placebo groups
Surgical Grading of Relaxation of the Surgical Field	approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure	Surgical grading of relaxation of the surgical field as per the Likert-4 point surgical grading of surgical field. During surgical exposure and closure.