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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Arm | Active Comparator | 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). |
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| Crossover Arm | Active Comparator | 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) . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex Injection [Bridion] | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 3 minutes after the study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 6 minutes |
| MEPs Amplitude Changes From Baseline at 9 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lashmi Venkatraghavan | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TWH/UHN | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34041634 | Derived | Venkatraghavan L, Royan N, Boyle SL, Dinsmore M, Lu N, Cushman K, Massicotte EM, Prabhu A. Effect of reversal of residual neuromuscular blockade on the amplitude of motor evoked potentials: a randomized controlled crossover study comparing sugammadex and placebo. Neurol Sci. 2022 Jan;43(1):615-623. doi: 10.1007/s10072-021-05318-8. Epub 2021 May 26. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Arm and Crossover Arm | The study participants will receive either 10ml syringe containing Sugammadex (2mg/kg) or 10 ml Placebo 10 ml in the initial arm and in the crossover arm they will recieve the other drug ( sugammadex or Placebo) Washout period is 3 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention After 3 hr Washout |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous | Posted | Median | Inter-Quartile Range | micro volts | Baseline and 3 minutes after the study intervention |
|
From the study intervention to the end of surgery, approximately 3 hours
All adverse events occurring during the study intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex Group | The study participants will receive a 10ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo (10 ml 0.9% normal saline) in the second phase. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Toronto Western Hospital/University Health Network | 416-603-5800 | 6237 | emad.alazazi@uhnresearch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2018 | May 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009123 | Muscle Hypotonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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Randomized controlled crossover trial comparing the change in MEP amplitudes with administration of sugammadex or placebo.
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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.
|
| Placebo | Drug | 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. |
|
|
Comparison of changes in MEP amplitudes from baseline at 9 minutes between sugammadex and placebo groups
| 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 | 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. | approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure |
|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms | Median | Inter-Quartile Range | micro volts |
|
The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase. |
|
|
|
| Secondary | 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 | Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous | Posted | Median | Inter-Quartile Range | micro volts | Baseline to 6 minutes |
|
|
|
| Secondary | MEPs Amplitude Changes From Baseline at 9 Minutes | Comparison of changes in MEP amplitudes from baseline at 9 minutes between sugammadex and placebo groups | Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous | Posted | Median | Inter-Quartile Range | micro volts | Baseline to 9 minutes |
|
|
|
| Secondary | Patient Movement | Number of patients moved and observed by the surgeon. From the study intervention to the surgeon observed patient movements | Posted | Number | participants | From 0 to 15 minutes |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo Group | The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase. | 0 | 38 | 0 | 38 | 0 | 38 |
The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Poor |
|