Comparison of AMG and EMG to Avoid Residual Paralysis After General Anesthesia
CAMEM
Comparison of AMG (Acceleromyography) and EMG (Electromyography) to Avoid Postoperative Residual Paralysis After General Anesthesia
1 other identifier
interventional
214
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
April 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 28, 2016
April 1, 2016
2 years
April 28, 2014
April 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
This study evaluates the precision and agreement of TOF-ratios obtained with acceleromyography and electromyography during residual neuromuscular paralysis
during surgery (2 hours)
Secondary Outcomes (1)
Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography
during surgery (2 hours)
Study Arms (2)
AMG (one-dimensionally) versus EMG
EXPERIMENTALNeuromuscular monitoring in patients scheduled for surgery under general anesthesia
AMG (three-dimensionally) versus EMG
EXPERIMENTALNeuromuscular monitoring in patients scheduled for surgery under general anesthesia
Interventions
Neuromuscular monitoring
Neuromuscular monitoring
Neuromuscular monitoring
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Anesthesiology
Munich, 81675, Germany
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, 81675, Germany
Related 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.
PMID: 19933538BACKGROUNDLiang 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.
PMID: 23821356BACKGROUNDEleveld 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.
PMID: 17312212BACKGROUNDPuhringer 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.
PMID: 20876699BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Blobner, M.D.
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
April 30, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 28, 2016
Record last verified: 2016-04