Posterior Cervical Decompression and Fusion
Conditions
Keywords
Motor Evoked Potentials, Spine surgery, Muscle relaxants
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.
Interventions
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.
Sponsors
Study design
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.
Intervention model description
Randomized controlled crossover trial comparing the change in MEP amplitudes with administration of sugammadex or placebo.
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
40 participants received 10ml syringe containing Sugammadex (2mg/kg) in the first phase, followed by Placebo 10 ml in the second phase or 10ml syringe containing Placebo in the first phase, followed by 10 ml of Sugammadex (2mg/kg) in the second phase. Time interval of approximately 3 hours between initial and crossover arm. 2 Patients withdrawn
Participants by arm
| Arm | Count |
|---|---|
| Study Intervention Initial Arm The study participants will receive10ml syringe containing Sugammadex (2mg/kg) in the first phase, followed by 10 ml of Placebo in the second phase.
Cross-over Arm The study participants will receive10ml syringe containing Placebo in the first phase, followed by 10 ml of Sugammadex (2mg/kg) in the second phase. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Second Intervention After 3 hr Washout | Equipment malfunction | 2 |
Baseline characteristics
| Characteristic | Study Intervention | — |
|---|---|---|
| Age, Customized Age | 60.8 Years STANDARD_DEVIATION 11.1 | — |
| Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Left FDI Placebo Group | 377.1 micro volts | — |
| Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Left FDI Sugammedex Group | 544.4 micro volts | — |
| Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Right FDI Placebo Group | 418.7 micro volts | — |
| Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Right FDI Sugammedex Group | 439.6 micro volts | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
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
Population: Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sugammadex | Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes | Left FDI amplitude changes from baseline at 3 min | 652.9 micro volts |
| Sugammadex | Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes | Right FDI amplitude changes from baseline at 3 min | 2153.4 micro volts |
| Placebo | Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes | Left FDI amplitude changes from baseline at 3 min | 20.6 micro volts |
| Placebo | Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes | Right FDI amplitude changes from baseline at 3 min | 55 micro volts |
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
Population: Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sugammadex | MEPs Amplitude Changes From Baseline at 9 Minutes | Left FDI | 894.9 micro volts |
| Sugammadex | MEPs Amplitude Changes From Baseline at 9 Minutes | Right FDI | 1256.3 micro volts |
| Placebo | MEPs Amplitude Changes From Baseline at 9 Minutes | Left FDI | 105.5 micro volts |
| Placebo | MEPs Amplitude Changes From Baseline at 9 Minutes | Right FDI | 337.2 micro volts |
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
Population: Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sugammadex | MEPs Amplitude Changes in Both Sugammadex and Placebo Groups | Left FDI | 646.4 micro volts |
| Sugammadex | MEPs Amplitude Changes in Both Sugammadex and Placebo Groups | Right FDI | 1609.3 micro volts |
| Placebo | MEPs Amplitude Changes in Both Sugammadex and Placebo Groups | Left FDI | 84.3 micro volts |
| Placebo | MEPs Amplitude Changes in Both Sugammadex and Placebo Groups | Right FDI | 201.9 micro volts |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Patient Movement | 6 participants |
| Placebo | Patient Movement | 0 participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sugammadex | Surgical Grading of Relaxation of the Surgical Field | Good or optimal condition | 31 Participants |
| Sugammadex | Surgical Grading of Relaxation of the Surgical Field | Acceptable | 6 Participants |
| Sugammadex | Surgical Grading of Relaxation of the Surgical Field | Poor | 1 Participants |
| Placebo | Surgical Grading of Relaxation of the Surgical Field | Poor | 0 Participants |
| Placebo | Surgical Grading of Relaxation of the Surgical Field | Good or optimal condition | 35 Participants |
| Placebo | Surgical Grading of Relaxation of the Surgical Field | Acceptable | 3 Participants |