Paraspinal Muscle Relaxation in Spine SurgeryTOFNCT03318718
Paraspinal Muscle Relaxation in Spine Surgery
A study testing Anesthesia with non-depolarizing NMBA Rocuronium, TOF measurement and MEP measurement in people with Paraspinal Muscle Relaxation in Spine Surgery, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
During anesthesia, neuromuscular blocking agents (NMBA) are routinely used for relaxation of muscles necessary for the conduction of the surgical procedure. Train-of-four (TOF) test is based on supramaximal stimulation of peripheral nerve resulting in four twitches: T1 to T4. Read more about this study
- Who is it for?
- Ages 14 to 99 years
- Conditions the study is for
- Paraspinal Muscle Relaxation in Spine Surgery
- What is being tested?
- Anesthesia with non-depolarizing NMBA Rocuronium, TOF measurement and MEP measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2016to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients that will undergo spinal surgery with intraoperative neurophysiological Monitoring
- Age: 14 - 99 years
Who cannot join
- No intraoperative neurophysiological Monitoring
- Age <14 year
- prior neurological diseases or deficits that may affect safety of surgery/Intraoperative neuromonitoring
- No informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Balgrist
Zurich, Canton of Zurich, 8008
About this study
Official title: Paraspinal Muscle Relaxation in Spine Surgery: Comparison of the Effect of Neuromuscular Blocking Agent Rocuronium Between Extremity- and Paraspinal Musculature
During anesthesia, neuromuscular blocking agents (NMBA) are routinely used for relaxation of muscles necessary for the conduction of the surgical procedure. Train-of-four (TOF) test is based on supramaximal stimulation of peripheral nerve resulting in four twitches: T1 to T4. The assessment of the NMBA blockade is performed routinely by measurement of the amplitude of compound muscle action potential (CMAP) and calculation of percentage of CMAP decrement from T1 to T4.
Train-of-four monitoring is routinely performed during spine surgery by stimulation of the ulnar nerve. Furthermore motor evoked potentials (MEPs) are routinely used in intraoperative neuromonitoring to assess the whole motor pathway from the cortical level down to the distal muscle. During anesthesia MEPs are routinely evoked by transcranial electrical stimulation with single or short train stimuli. In clinical practice even though full muscle relaxation of the hand by NMBA can be observed, utilizing the TOF test, remaining muscle tonus can be observed at the paraspinal musculature during spine surgery.
The goals of this study are to determine (1) if any differences between muscle relaxation of the hand and foot (measured by TOF test and MEPs) and MEPs of the paraspinal musculature occur; (2) how much more NMBA must be administered to achieve full muscle relaxation of the paraspinal musculature in comparison to the hand or foot.
Read the detailed description
Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until TOF 0 at the hand is achieved. TOF measurements will be performed at baseline 5 minutes after induction. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus. When TOF 0 at the hand is achieved the MEPs of the paraspinal musculature will be measured. When there is remaining muscle tonus of the paraspinal musculature another bolus of rocuronium is administered until no MEPs can be measured for the paraspinal musculature.
- Being tested
- Anesthesia with non-depolarizing NMBA Rocuronium, TOF measurement, MEP measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia with non-depolarizing NMBA RocuroniumDrug
Non- depolarizing NMBA Rocuronium will be used until full paraspinal muscle Relaxation. Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until good surgical conditions are achieved.
TOF measurementDiagnostic test
TOF (Train-of-four) measurements will be performed at baseline 5 minutes after induction after the effect of succinylcholine will have run off. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus
MEP measurementDiagnostic test
MEPs (motor evoked potentials) are routinely obtained after intubation and before surgery, then every 10min during the critical preparation and closing phases of surgery and every 5min during the correction phase. In addition MEPs will be measured after the administration of the NMBA rocuronium. Baseline values for amplitudes and latencies are obtained directly prior to the start of the correction phase of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| TOF measurement | Experimental | TOF and MEP measurement after Anesthesia with non-depolarizing NMBA Rocuronium Receives: Drug: Anesthesia with non-depolarizing NMBA Rocuronium; Diagnostic Test: TOF measurement; Diagnostic Test: MEP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of NMBA blockade
assessment of the NMBA (neuromuscular blocking agent) blockade by measurement of the amplitude of compound muscle action potential (CMAP)
Measured: during surgery
MEP
Motor evoked potentials (MEPs) are measured in hand, foot and paraspinal musculature
Measured: during surgery
TOF
peak-to-peak amplitude of CMAP for each of 4 muscle contractions is measured. (supramaximal stimulation of peripheral nerve results in four twitches: T1 to T4)
Measured: during surgery
Secondary outcomes (1)
necessary administered amount of NMBA
Difference in the necessary administered amount of NMBA to achieve full muscle relaxation for hand and foot versus paraspinal musculature
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Feb 2016
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paraspinal Muscle Relaxation in Spine SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Betz, Dr.med., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318718
- Sponsor's protocol ID
- TOF
- Acronym
- TOF
- Status last verified
- Feb 2019
- First submitted
- 29 Jun 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Betz M, Aguirre J, Schubert M, Gotschi T, Huber B, Schupbach R, Brada M, Spirig JM, Farshad M. Hand or foot train-of-four tests and surgical site muscle relaxation assessed with multiple motor evoked potentials: A prospective observational study. Eur J Anaesthesiol. 2021 Aug 1;38(8):872-879. doi: 10.1097/EJA.0000000000001398.
PubMed 33259448
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraspinal Muscle Relaxation in Spine Surgery: Comparison of the Effect of Neuromuscular Blocking Agent Rocuronium Between Extremity- and Paraspinal Musculature
- ClinicalTrials.gov ID
- NCT03318718
- Acronym / sponsor ID
- TOF / TOF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During anesthesia, neuromuscular blocking agents (NMBA) are routinely used for relaxation of muscles necessary for the conduction of the surgical procedure. Train-of-four (TOF) test is based on supramaximal stimulation of peripheral nerve resulting in four twitches: T1 to T4. The assessment of the NMBA blockade is performed routinely by measurement of the amplitude of compound muscle action potential (CMAP) and calculation of percentage of CMAP decrement from T1 to T4.
Train-of-four monitoring is routinely performed during spine surgery by stimulation of the ulnar nerve. Furthermore motor evoked potentials (MEPs) are routinely used in intraoperative neuromonitoring to assess the whole motor pathway from the cortical level down to the distal muscle. During anesthesia MEPs are routinely evoked by transcranial electrical stimulation with single or short train stimuli. In clinical practice even though full muscle relaxation of the hand by NMBA can be observed, utilizing the TOF test, remaining muscle tonus can be observed at the paraspinal musculature during spine surgery.
The goals of this study are to determine (1) if any differences between muscle relaxation of the hand and foot (measured by TOF test and MEPs) and MEPs of the paraspinal musculature occur; (2) how much more NMBA must be administered to achieve full muscle relaxation of the paraspinal musculature in comparison to the hand or foot.
Detailed description
Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until TOF 0 at the hand is achieved. TOF measurements will be performed at baseline 5 minutes after induction. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus. When TOF 0 at the hand is achieved the MEPs of the paraspinal musculature will be measured. When there is remaining muscle tonus of the paraspinal musculature another bolus of rocuronium is administered until no MEPs can be measured for the paraspinal musculature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOF measurement | Experimental | Drug: Anesthesia with non-depolarizing NMBA Rocuronium, Diagnostic Test: TOF measurement, Diagnostic Test: MEP measurementTOF and MEP measurement after Anesthesia with non-depolarizing NMBA Rocuronium |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients that will undergo spinal surgery with intraoperative neurophysiological Monitoring
- Age: 14 - 99 years
Key exclusion criteria (4 listed)
- No intraoperative neurophysiological Monitoring
- Age <14 year
- prior neurological diseases or deficits that may affect safety of surgery/Intraoperative neuromonitoring
- No informed consent
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 |
|---|---|---|
| Anesthesia with non-depolarizing NMBA RocuroniumNon- depolarizing NMBA Rocuronium will be used until full paraspinal muscle Relaxation. Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until good surgical conditions are achieved. | Drug | TOF measurement |
| TOF measurementTOF (Train-of-four) measurements will be performed at baseline 5 minutes after induction after the effect of succinylcholine will have run off. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus | Diagnostic test | TOF measurement |
| MEP measurementMEPs (motor evoked potentials) are routinely obtained after intubation and before surgery, then every 10min during the critical preparation and closing phases of surgery and every 5min during the correction phase. In addition MEPs will be measured after the administration of the NMBA rocuronium. Baseline values for amplitudes and latencies are obtained directly prior to the start of the correction phase of the surgery. | Diagnostic test | TOF measurement |
Primary outcome
assessment of NMBA blockade
Time frame: during surgery
assessment of the NMBA (neuromuscular blocking agent) blockade by measurement of the amplitude of compound muscle action potential (CMAP)
MEP
Time frame: during surgery
Motor evoked potentials (MEPs) are measured in hand, foot and paraspinal musculature
TOF
Time frame: during surgery
peak-to-peak amplitude of CMAP for each of 4 muscle contractions is measured. (supramaximal stimulation of peripheral nerve results in four twitches: T1 to T4)
1 secondary outcome
necessary administered amount of NMBA
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 33259448Betz M, Aguirre J, Schubert M, Gotschi T, Huber B, Schupbach R, Brada M, Spirig JM, Farshad M. Hand or foot train-of-four tests and surgical site muscle relaxation assessed with multiple motor evoked potentials: A prospective observational study. Eur J Anaesthesiol. 2021 Aug 1;38(8):872-879. doi: 10.1097/EJA.0000000000001398.
- Individual participant dataSharing planned: Undecided
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.
Michael Betz, Dr.med. principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia with non-depolarizing NMBA Rocuronium, TOF measurement and MEP measurement in people with Paraspinal Muscle Relaxation in Spine Surgery, run by Balgrist University Hospital at 1 site in Switzerland.
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 4 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 18 Feb 2019. 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 Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
assessment of NMBA blockade (time frame: during surgery). The study lists 3 primary outcomes in all. 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 NCT03318718, 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 18 Feb 2019.