Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007279

Trial Description

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Title

Comparison of AMG (Acceleromyography) and EMG (Electromyography) to Avoid Postoperative Residual Paralysis After General Anesthesia

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Trial Acronym

CAMEM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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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Organizational Data

  •   DRKS00007279
  •   2015/08/20
  •   2014/04/28
  •   yes
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Secondary IDs

  •   NCT02126852  (ClinicalTrials.gov)
  •   CAMEM  (Technische Universität München)
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Health Condition or Problem studied

  •   Observation of Neuromuscular Block
  •   Respiratory Paralysis
  •   Anaesthesia
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Interventions/Observational Groups

  •   Device: Acceleromyography (AMG, one-dimensionally)
  •   Device: Acceleromyography (AMG, three-dimensionally)
  •   Device: Electromyography (EMG)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Diagnostic
  •   Parallel
  •   N/A
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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)

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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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/04/30
  •   200
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Technische Universität München
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    • Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany
    • Manfred Blobner, M.D. 
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    • Manfred Blobner, M.D. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   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.; 19933538
  •   Liang 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.; 23821356
  •   Eleveld 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.; 17312212
  •   Pühringer 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.; 20876699
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.