Posterior Cervical Decompression and FusionPhase 4NCT03087513
A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
A Phase 4 study testing Sugammadex Injection [Bridion] in people with Posterior Cervical Decompression and Fusion, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posterior Cervical Decompression and Fusion
- What is being tested?
- Sugammadex Injection [Bridion]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2018to 30 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Reversal of Neuromuscular Blockade on the Amplitude of Motor Evoked Potentials: A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
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.
Read the 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;
- Patients cannot be monitored for neurological changes during their transfer into the prone position
- 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.
- Being tested
- Sugammadex Injection [Bridion], Placebo
- Keywords
- Motor Evoked Potentials, Spine surgery, Muscle relaxants
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex Injection [Bridion]Drug
Also called Sugammadex
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.
PlaceboDrug
Also called Normal Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Sugammadex Injection [Bridion]; Drug: Placebo |
| 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) . Receives: Drug: Sugammadex Injection [Bridion]; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3 minutes after the study intervention
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start5 Feb 2018
- Primary completion30 Dec 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Cervical Decompression and FusionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled crossover trial comparing the change in MEP amplitudes with administration of sugammadex or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Lashmi Venkatraghavan, University Health Network, Toronto
- Investigators
- Lashmi Venkatraghavan, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087513
- Sponsor's protocol ID
- 16-5926-B
- Status last verified
- Jun 2020
- First submitted
- 6 Mar 2017
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34041634
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reversal of Neuromuscular Blockade on the Amplitude of Motor Evoked Potentials: A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
- ClinicalTrials.gov ID
- NCT03087513
- Acronym / sponsor ID
- 16-5926-B
- Keywords
- Motor Evoked Potentials, Spine surgery, Muscle relaxants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 1 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Patients cannot be monitored for neurological changes during their transfer into the prone position
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled crossover trial comparing the change in MEP amplitudes with administration of sugammadex or placebo.
| Arm | Type | Receives |
|---|---|---|
| Initial Arm | Active comparator | Drug: Sugammadex Injection [Bridion], Drug: PlaceboThe 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 | Active comparator | Drug: Sugammadex Injection [Bridion], Drug: PlaceboThe 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) . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadex Injection [Bridion]Also: SugammadexThe 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. | Drug | Crossover Arm, Initial Arm |
| PlaceboAlso: Normal SalineThe 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. | Drug | Crossover Arm, Initial Arm |
Primary outcome
Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes
Time frame: 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
4 secondary outcomes
MEPs Amplitude Changes in Both Sugammadex and Placebo Groups
Time frame: Baseline to 6 minutes
MEPs Amplitude Changes From Baseline at 9 Minutes
Time frame: Baseline to 9 minutes
Patient Movement
Time frame: From 0 to 15 minutes
Surgical Grading of Relaxation of the Surgical Field
Time frame: approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34041634Venkatraghavan 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.
- Individual participant dataSharing planned: No
Related trials for Posterior Cervical Decompression and Fusion
Recruiting
Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy
Cervical Spondylotic Myelopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lashmi Venkatraghavan principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex Injection [Bridion] in people with Posterior Cervical Decompression and Fusion, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes (time frame: Baseline and 3 minutes after the study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03087513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.