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Comparison of AMG and EMG to Avoid Residual Paralysis After General Anesthesia (CAMEM)

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ClinicalTrials.gov Identifier: NCT02126852
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief 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 a clinical setting.

Condition or disease Intervention/treatment Phase
Observation of Neuromuscular Block Respiratory Paralysis Anaesthesia Device: Acceleromyography (AMG, one-dimensionally) Device: Acceleromyography (AMG, three-dimensionally) Device: Electromyography (EMG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of AMG (Acceleromyography) and EMG (Electromyography) to Avoid Postoperative Residual Paralysis After General Anesthesia
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
Experimental: AMG (one-dimensionally) versus EMG
Neuromuscular monitoring in patients scheduled for surgery under general anesthesia
Device: Acceleromyography (AMG, one-dimensionally)
Neuromuscular monitoring

Device: Electromyography (EMG)
Neuromuscular monitoring

Experimental: AMG (three-dimensionally) versus EMG
Neuromuscular monitoring in patients scheduled for surgery under general anesthesia
Device: Acceleromyography (AMG, three-dimensionally)
Neuromuscular monitoring

Device: Electromyography (EMG)
Neuromuscular monitoring




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography [ Time Frame: during surgery (2 hours) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126852


Locations
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Germany
Department of Anesthesiology
Munich, Germany, 81675
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Manfred Blobner, M.D. Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany
Publications:
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02126852    
Other Study ID Numbers: CAMEM
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Technische Universität München:
residual paralysis,neuromuscular blockade,acceleromyography,electromyography
Additional relevant MeSH terms:
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Respiratory Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases