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Measuring the electromyographic (EMC) muscle response


- candidate number19418
- NTR NumberNTR4777
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2014
- Secondary IDs2014/218 
- Public TitleMeasuring the electromyographic (EMC) muscle response
- Scientific TitleNeurostimulation and Electromyographic Assessment of the TetraGraph
- ACRONYMNEAT
- hypothesisThere is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting
- Healt Condition(s) or Problem(s) studiedNeuromuscular blockade
- Inclusion criteria- Age 18 years or older;
- Subject meets the American Society of Anesthesiology (ASA) physical status I-III criteria (Table I);
- Subject has provided written informed consent.
- Exclusion criteria- Presence of an underlying neuromuscular disease
- Presence of renal or hepatic disease
- Subject has open skin sores at locations needed for electrode application
- Patient taking the following medication:
- anti-seizure medication
- anti-cholinestase medication
- magnesium sulfate
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 10-sep-2014
- planned closingdate1-nov-2014
- Target number of participants30
- InterventionsAs this is an observational trial, no additional interventions will be done.
- Primary outcomeThe primary objective of this study is to provide EMG performance data of the TetraGraph device on anesthetized subjects. Performance will be assessed post hoc by analyzing objective EMG data and correlating with the responses to annotations made during the surgical procedure (e.g., correlating the EMG responses to the time of NMBA administration).
- Secondary outcomeo Investigating the quality of the applied skin electrodes (clinically available 3M Red Dot electrodes)

o Observing the applicability of the prototype (easy of use, )
- TimepointsDuring operation
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Spanjersberg
- CONTACT for SCIENTIFIC QUERIESProf. dr. M.M.R.F. Struys
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryIncomplete recovery from neuromuscular blockade after anesthesia and surgery continues to be a common problem in the post-anesthesia care unit. There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting using neurostimulation
- Main changes (audit trail)
- RECORD9-sep-2014 - 1-dec-2014


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