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

Anaesthesia Clinical Trial

— CAMEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126852
• Other study ID #: CAMEM
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: April 27, 2016
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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 a clinical setting.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anaesthesia
• Observation of Neuromuscular Block
• Paralysis
• Respiratory Paralysis

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology	Munich
Germany	Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study evaluates the precision and agreement of TOF-ratios obtained with acceleromyography and electromyography during residual neuromuscular paralysis		during surgery (2 hours)	Yes
Secondary	Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography		during surgery (2 hours)	Yes