Phase 4
N=40
A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
Posterior Cervical Decompression and Fusion
Bottom Line
View on ClinicalTrials.gov: NCT03087513 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes — 652.9; 20.6; 2153.4; 55 micro volts — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex Injection [Bridion] (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes |
652.9; 20.6; 2153.4; 55 | <0.01 sig |
| SECONDARY MEPs Amplitude Changes in Both Sugammadex and Placebo Groups |
646.4; 84.3; 1609.3; 201.9 | — |
| SECONDARY MEPs Amplitude Changes From Baseline at 9 Minutes |
894.9; 105.5; 1256.3; 337.2 | — |
| SECONDARY Patient Movement |
6; 0 | — |
| SECONDARY Surgical Grading of Relaxation of the Surgical Field |
31; 35; 6; 3; 1; 0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03087513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.