Observation of Neuromuscular BlockCAMEMNCT02126852
Comparison of AMG and EMG to Avoid Residual Paralysis After General Anesthesia
A study testing Acceleromyography (AMG, one-dimensionally), Acceleromyography (AMG, three-dimensionally) and Electromyography (EMG) in people with Observation of Neuromuscular Block and Respiratory Paralysis, run by Technical University of Munich at 2 sites in Germany.
Trial summary
This study evaluates three different neuromuscular monitoring devices (acceleromyography, one- or three-dimensional, and electromyography) with regard to their precision to detect residual paralysis after injection of neuromuscular blocking agents and recurrence of paralysis after administration of reversal agents in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Observation of Neuromuscular Block, Respiratory Paralysis, Anaesthesia
- What is being tested?
- Acceleromyography (AMG, one-dimensionally), Acceleromyography (AMG, three-dimensionally) and Electromyography (EMG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2014to Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ASA physical status I-III
- Patients older than 18 years
- General anesthesia with the use of the neuromuscular blocking agent rocuronium
- Expected duration of surgery more than 2 hours
- Patients having given informed consent to the study
Who cannot join
- Known or suspected allergy towards anesthetics/sugammadex or rocuronium
- Pregnant and breastfeeding women
- Known or suspected neuromuscular disease (Multiple sclerosis, myasthenia gravis)
- Anatomic and functional malformations with expected difficult intubation
- body mass index >35kg/m2
- Contraindication for the use of rocuronium or sugammadex
- Malignant hyperthermia
- Patients with a legal guardian
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Anesthesiology
Munich, 81675
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, 81675
About this study
Official title: Comparison of AMG (Acceleromyography) and EMG (Electromyography) to Avoid Postoperative Residual Paralysis After General Anesthesia
This study evaluates three different neuromuscular monitoring devices (acceleromyography, one- or three-dimensional, and electromyography) with regard to their precision to detect residual paralysis after injection of neuromuscular blocking agents and recurrence of paralysis after administration of reversal agents in a clinical setting.
Read the detailed description
Neuromuscular blocking agents (NMBAs) are routinely used as standard part of a modern, balanced anesthesia regime. A residual duration of action exceeding the end of surgery, also called residual neuromuscular paralysis, is a common undesired side effect and increases the risk for postoperative pulmonary complications such as aspiration or pneumonia delaying patients' discharge from the post-anesthesia care unit. To limit the incidence of residual paralysis in daily anesthesia care, quantitative neuromuscular monitoring is recommended after injection of NMBAs. If a residual effect of a NMBA is detected at the end of surgery, reversal agents such as cholinesterase inhibitors, e.g. neostigmine or a selective relaxant binding agent, e.g. sugammadex can be administered. However, if reversal agents are not adequately dosed, the risk for a residual neuromuscular blockade re-occurs. Accordingly, neuromuscular monitoring is also useful to control the action of the administered reversal agents.
Although several techniques of neuromuscular monitoring are established in clinical practice, electromyography (EMG) and acceleromyography (AMG) are the most common quantitative neuromuscular monitoring devices. Electromyography, the gold standard for detecting residual neuromuscular block, is based on measuring summarized spikes of evoked muscle contractions. Acceleromyography measuring the acceleration of evoked muscle contraction is also commercially available and easy to use. This acceleration, however, can be measured both one-dimensionally and three-dimensionally.
This study evaluates the three described neuromuscular monitoring devices with regard to their precision to detect residual paralysis after administration of NMBAs and recurrence of neuromuscular blockade after administration of reversal agents in a clinical setting. We plan to include and randomize a total of 200 patients. The study participants will be recruited from patients scheduled for surgery at the Klinikum rechts der Isar der Technischen Universität München, Munich, Germany. In each patient, acceleromyography (either one- or three-dimensional) will be compared with the calibrated electromyography. The findings will help to indicate which neuromuscular monitoring device is most suitable for detecting residual paralysis and recurrent neuromuscular blockade.
- Being tested
- Acceleromyography (AMG, one-dimensionally), Acceleromyography (AMG, three-dimensionally), Electromyography (EMG)
- Keywords
- residual paralysis,neuromuscular blockade,acceleromyography,electromyography
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceleromyography (AMG, one-dimensionally)Device
Neuromuscular monitoring
Acceleromyography (AMG, three-dimensionally)Device
Neuromuscular monitoring
Electromyography (EMG)Device
Neuromuscular monitoring
| Study group | Role | What they receive |
|---|---|---|
| AMG (one-dimensionally) versus EMG | Experimental | Neuromuscular monitoring in patients scheduled for surgery under general anesthesia Receives: Device: Acceleromyography (AMG, one-dimensionally); Device: Electromyography (EMG) |
| AMG (three-dimensionally) versus EMG | Experimental | Neuromuscular monitoring in patients scheduled for surgery under general anesthesia Receives: Device: Acceleromyography (AMG, three-dimensionally); Device: Electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study evaluates the precision and agreement of TOF-ratios obtained with acceleromyography and electromyography during residual neuromuscular paralysis
Measured: during surgery (2 hours)
Secondary outcomes (1)
Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography
Measured: during surgery (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Observation of Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manfred Blobner, M.D., Principal investigator, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126852
- Sponsor's protocol ID
- CAMEM
- Acronym
- CAMEM
- Status last verified
- Apr 2016
- First submitted
- 28 Apr 2014
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.
PubMed 19933538Liang SS, Stewart PA, Phillips S. An ipsilateral comparison of acceleromyography and electromyography during recovery from nondepolarizing neuromuscular block under general anesthesia in humans. Anesth Analg. 2013 Aug;117(2):373-9. doi: 10.1213/ANE.0b013e3182937fc4. Epub 2013 Jul 2.
PubMed 23821356Eleveld DJ, Kuizenga K, Proost JH, Wierda JM. A temporary decrease in twitch response during reversal of rocuronium-induced muscle relaxation with a small dose of sugammadex. Anesth Analg. 2007 Mar;104(3):582-4. doi: 10.1213/01.ane.0000250617.79166.7f.
PubMed 17312212Puhringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br J Anaesth. 2010 Nov;105(5):610-9. doi: 10.1093/bja/aeq226. Epub 2010 Sep 28.
PubMed 20876699
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of AMG (Acceleromyography) and EMG (Electromyography) to Avoid Postoperative Residual Paralysis After General Anesthesia
- ClinicalTrials.gov ID
- NCT02126852
- Acronym / sponsor ID
- CAMEM / CAMEM
- Keywords
- residual paralysis,neuromuscular blockade,acceleromyography,electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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.
This study evaluates three different neuromuscular monitoring devices (acceleromyography, one- or three-dimensional, and electromyography) with regard to their precision to detect residual paralysis after injection of neuromuscular blocking agents and recurrence of paralysis after administration of reversal agents in a clinical setting.
Detailed description
Neuromuscular blocking agents (NMBAs) are routinely used as standard part of a modern, balanced anesthesia regime. A residual duration of action exceeding the end of surgery, also called residual neuromuscular paralysis, is a common undesired side effect and increases the risk for postoperative pulmonary complications such as aspiration or pneumonia delaying patients' discharge from the post-anesthesia care unit. To limit the incidence of residual paralysis in daily anesthesia care, quantitative neuromuscular monitoring is recommended after injection of NMBAs. If a residual effect of a NMBA is detected at the end of surgery, reversal agents such as cholinesterase inhibitors, e.g. neostigmine or a selective relaxant binding agent, e.g. sugammadex can be administered. However, if reversal agents are not adequately dosed, the risk for a residual neuromuscular blockade re-occurs. Accordingly, neuromuscular monitoring is also useful to control the action of the administered reversal agents.
Although several techniques of neuromuscular monitoring are established in clinical practice, electromyography (EMG) and acceleromyography (AMG) are the most common quantitative neuromuscular monitoring devices. Electromyography, the gold standard for detecting residual neuromuscular block, is based on measuring summarized spikes of evoked muscle contractions. Acceleromyography measuring the acceleration of evoked muscle contraction is also commercially available and easy to use. This acceleration, however, can be measured both one-dimensionally and three-dimensionally.
This study evaluates the three described neuromuscular monitoring devices with regard to their precision to detect residual paralysis after administration of NMBAs and recurrence of neuromuscular blockade after administration of reversal agents in a clinical setting. We plan to include and randomize a total of 200 patients. The study participants will be recruited from patients scheduled for surgery at the Klinikum rechts der Isar der Technischen Universität München, Munich, Germany. In each patient, acceleromyography (either one- or three-dimensional) will be compared with the calibrated electromyography. The findings will help to indicate which neuromuscular monitoring device is most suitable for detecting residual paralysis and recurrent neuromuscular blockade.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG (one-dimensionally) versus EMG | Experimental | Device: Acceleromyography (AMG, one-dimensionally), Device: Electromyography (EMG)Neuromuscular monitoring in patients scheduled for surgery under general anesthesia |
| AMG (three-dimensionally) versus EMG | Experimental | Device: Acceleromyography (AMG, three-dimensionally), Device: Electromyography (EMG)Neuromuscular monitoring in patients scheduled for surgery under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ASA physical status I-III
- Patients older than 18 years
- General anesthesia with the use of the neuromuscular blocking agent rocuronium
- Expected duration of surgery more than 2 hours
- Patients having given informed consent to the study
Key exclusion criteria (8 listed)
- Known or suspected allergy towards anesthetics/sugammadex or rocuronium
- Pregnant and breastfeeding women
- Known or suspected neuromuscular disease (Multiple sclerosis, myasthenia gravis)
- Anatomic and functional malformations with expected difficult intubation
- body mass index >35kg/m2
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 |
|---|---|---|
| Acceleromyography (AMG, one-dimensionally)Neuromuscular monitoring | Device | AMG (one-dimensionally) versus EMG |
| Acceleromyography (AMG, three-dimensionally)Neuromuscular monitoring | Device | AMG (three-dimensionally) versus EMG |
| Electromyography (EMG)Neuromuscular monitoring | Device | AMG (one-dimensionally) versus EMG, AMG (three-dimensionally) versus EMG |
Primary outcome
This study evaluates the precision and agreement of TOF-ratios obtained with acceleromyography and electromyography during residual neuromuscular paralysis
Time frame: during surgery (2 hours)
1 secondary outcome
Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography
Time frame: during surgery (2 hours)
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 28 Apr 2016.
- Background: PubMed 19933538Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.
- Background: PubMed 23821356Liang SS, Stewart PA, Phillips S. An ipsilateral comparison of acceleromyography and electromyography during recovery from nondepolarizing neuromuscular block under general anesthesia in humans. Anesth Analg. 2013 Aug;117(2):373-9. doi: 10.1213/ANE.0b013e3182937fc4. Epub 2013 Jul 2.
- Background: PubMed 17312212Eleveld DJ, Kuizenga K, Proost JH, Wierda JM. A temporary decrease in twitch response during reversal of rocuronium-induced muscle relaxation with a small dose of sugammadex. Anesth Analg. 2007 Mar;104(3):582-4. doi: 10.1213/01.ane.0000250617.79166.7f.
- Background: PubMed 20876699Puhringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br J Anaesth. 2010 Nov;105(5):610-9. doi: 10.1093/bja/aeq226. Epub 2010 Sep 28.
- Individual participant dataSharing planned: Undecided
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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.
Manfred Blobner, M.D. principal investigator
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceleromyography (AMG, one-dimensionally), Acceleromyography (AMG, three-dimensionally) and Electromyography (EMG) in people with Observation of Neuromuscular Block and Respiratory Paralysis, run by Technical University of Munich at 2 sites in Germany.
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 5 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
This study evaluates the precision and agreement of TOF-ratios obtained with acceleromyography and electromyography during residual neuromuscular paralysis (time frame: during surgery (2 hours)). 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 NCT02126852, which also lists 4 linked publications.
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 28 Apr 2016.