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

Primary Purpose

Observation of Neuromuscular Block, Respiratory Paralysis, Anaesthesia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acceleromyography (AMG, one-dimensionally)
Acceleromyography (AMG, three-dimensionally)
Electromyography (EMG)
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Observation of Neuromuscular Block focused on measuring residual paralysis,neuromuscular blockade,acceleromyography,electromyography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology
  • Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AMG (one-dimensionally) versus EMG

AMG (three-dimensionally) versus EMG

Arm Description

Neuromuscular monitoring in patients scheduled for surgery under general anesthesia

Neuromuscular monitoring in patients scheduled for surgery under general anesthesia

Outcomes

Primary Outcome Measures

This study evaluates the precision and agreement of TOF-ratios obtained with acceleromyography and electromyography during residual neuromuscular paralysis

Secondary Outcome Measures

Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography

Full Information

First Posted
April 28, 2014
Last Updated
April 27, 2016
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02126852
Brief Title
Comparison of AMG and EMG to Avoid Residual Paralysis After General Anesthesia
Acronym
CAMEM
Official Title
Comparison of AMG (Acceleromyography) and EMG (Electromyography) to Avoid Postoperative Residual Paralysis After General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Observation of Neuromuscular Block, Respiratory Paralysis, Anaesthesia
Keywords
residual paralysis,neuromuscular blockade,acceleromyography,electromyography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMG (one-dimensionally) versus EMG
Arm Type
Experimental
Arm Description
Neuromuscular monitoring in patients scheduled for surgery under general anesthesia
Arm Title
AMG (three-dimensionally) versus EMG
Arm Type
Experimental
Arm Description
Neuromuscular monitoring in patients scheduled for surgery under general anesthesia
Intervention Type
Device
Intervention Name(s)
Acceleromyography (AMG, one-dimensionally)
Intervention Description
Neuromuscular monitoring
Intervention Type
Device
Intervention Name(s)
Acceleromyography (AMG, three-dimensionally)
Intervention Description
Neuromuscular monitoring
Intervention Type
Device
Intervention Name(s)
Electromyography (EMG)
Intervention Description
Neuromuscular monitoring
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography
Time Frame
during surgery (2 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Blobner, M.D.
Organizational Affiliation
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19933538
Citation
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.
Results Reference
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PubMed Identifier
23821356
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. Erratum In: Anesth Analg. 2017 May;124(5):1745.
Results Reference
background
PubMed Identifier
17312212
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. doi: 10.1213/01.ane.0000250617.79166.7f.
Results Reference
background
PubMed Identifier
20876699
Citation
Puhringer 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.
Results Reference
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Comparison of AMG and EMG to Avoid Residual Paralysis After General Anesthesia

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