A Phase 4 interventional study of Sugammadex Injection [Bridion] and Placebo in Posterior Cervical Decompression and Fusion, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-17.
Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Prevention
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.
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;
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.
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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).
Drug: Sugammadex Injection [Bridion] · Drug: 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) .
Drug: Sugammadex Injection [Bridion] · Drug: Placebo
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.
Also known as: Sugammadex
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.
Also known as: Normal Saline
Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes
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
Time frame: Baseline and 3 minutes after the study intervention
MEPs Amplitude Changes in Both Sugammadex and Placebo Groups
Changes in the amplitude of the MEPs from the baseline in the first dorsal interosseous muscle at 6 minutes
Time frame: Baseline to 6 minutes
MEPs Amplitude Changes From Baseline at 9 Minutes
Comparison of changes in MEP amplitudes from baseline at 9 minutes between sugammadex and placebo groups
Time frame: Baseline to 9 minutes
Patient Movement
Number of patients moved and observed by the surgeon. From the study intervention to the surgeon observed patient movements
Time frame: From 0 to 15 minutes
Surgical Grading of Relaxation of the Surgical Field
Surgical grading of relaxation of the surgical field as per the Likert-4 point surgical grading of surgical field. During surgical exposure and closure.
Time frame: approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure
Between February 2018 and April 2019, 73 posterior cervical spine patients screened from the preoperative assessment clinic of Toronto Western Hospital to identify eligible patients. First participant was enrolled on March 2018 and the last participant was enrolled on April 2019.
| Milestone | Initial Arm and Crossover Arm |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
| Milestone | Initial Arm and Crossover Arm |
|---|---|
| Started | 40 |
| Completed | 38 |
| Not completed | 2 |
| Withdrew: Equipment malfunction | 2 |
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
| micro volts | Sugammadex | Placebo |
|---|---|---|
| Left FDI amplitude changes from baseline at 3 min | 652.9 (142 to 1650) | 20.6 (-183.5 to 297.5) |
| Right FDI amplitude changes from baseline at 3 min | 2153.4 (1400 to 4536.8) | 55 (-65.2 to 480.8) |
Changes in the amplitude of the MEPs from the baseline in the first dorsal interosseous muscle at 6 minutes
| micro volts | Sugammadex Group | Placebo Group |
|---|---|---|
| Left FDI | 646.4 (253.1 to 1580.9) | 84.3 (-178.6 to 679.8) |
| Right FDI | 1609.3 (632.4 to 5535.7) | 201.9 (-0.525 to 760.7) |
Comparison of changes in MEP amplitudes from baseline at 9 minutes between sugammadex and placebo groups
| micro volts | Sugammedex Group | Placebo Group |
|---|---|---|
| Left FDI | 894.9 (234.1 to 2261.2) | 105.5 (-115.2 to 775) |
| Right FDI | 1256.3 (308.9 to 2533.1) | 337.2 (-17.5 to 2215.8) |
Number of patients moved and observed by the surgeon. From the study intervention to the surgeon observed patient movements
| participants | Sugammadex Group | Placebo Group |
|---|---|---|
| Patient Movement | 6 | 0 |
Surgical grading of relaxation of the surgical field as per the Likert-4 point surgical grading of surgical field. During surgical exposure and closure.
| Participants | Sugammadex | Placebo |
|---|---|---|
| Good or optimal condition | 31 | 35 |
| Acceptable | 6 | 3 |
| Poor | 1 | 0 |
Collected over From the study intervention to the end of surgery, approximately 3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugammadex Group | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Placebo Group | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Age, Customized(Years) | Study Intervention |
|---|---|
| Age | 60.8 ± 11.1 |
| Sex: Female, Male(Participants) | Study Intervention |
|---|---|
| Female | 21 |
| Male | 17 |
| Race and Ethnicity Not Collected(Participants) | Study Intervention |
|---|
| Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms(micro volts) | Study Intervention |
|---|---|
| Left FDI Sugammedex Group | 544.4 (165.8 to 1300) |
| Left FDI Placebo Group | 377.1 (107.2 to 1650) |
| Right FDI Sugammedex Group | 439.6 (101 to 1900) |
| Right FDI Placebo Group | 418.7 (83.7 to 1425) |
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University Health Network, Toronto