Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.
NCT ID: NCT03219138
Last Updated: 2017-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
265 participants
INTERVENTIONAL
2008-01-08
2009-07-25
Brief Summary
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Detailed Description
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Methods: After extubation a blinded anesthetist performs eight clinical tests in 165 patients. Test results are correlated to calibrated electromyography train-of-four (TOF) ratio and to a postoperatively applied uncalibrated acceleromyography. A classification and regression tree (CART) is calculated developing the algorithm to identify PORC. This is validated against uncalibrated acceleromyography and tactile judgement of TOF fading in separate 100 patients.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
After surgery patients' trachea is extubated according to clinical judgement. Immediately after extubation blinded anaesthesiologist tests the patient. The postoperative evaluation of neuromuscular function consists of eight clinical tests applied in a random order.
Thereafter, an uncalibrated acceleromyography (50 mA, 2 Hz) is started on the contralateral arm and TOF ratio is measured.
During the validation part of the developed algorithm the anaesthesiologist additionally had to judge tactile fading of the adductor pollicis.
If a patient had any clinical signs of neuromuscular dysfunction, reversal with neostigmine is administered.
DIAGNOSTIC
SINGLE
The blinded anaesthesiologist is unable to see the data on the EMG monitor and the movement of the adductor pollicis muscle.
Study Groups
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Electromyography
Neuromuscular function was monitored, using evoked electromyography of the adductor pollicis muscle with a neuromuscular transmission module by a non-blinded investigator.
No interventions assigned to this group
Acceleromyography
Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.
Acceleromyography
Use of an uncalibrated acceleromyography
Interventions
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Acceleromyography
Use of an uncalibrated acceleromyography
Eligibility Criteria
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Inclusion Criteria
* orthopedic
* minor visceral surgery
Exclusion Criteria
* body mass index over 30
* history of neuromuscular diseases
* gastro-esophageal reflux disease.
18 Years
65 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
University Hospital Muenster
OTHER
University Hospital Schleswig-Holstein
OTHER
Johannes Gutenberg University Mainz
OTHER
University of Regensburg
OTHER
Responsible Party
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Christoph Unterbuchner
Principal Investigator
Locations
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6Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,
Kiel, , Germany
Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster
Münster, , Germany
Klinik für Anaesthesiologie und operative Intensivmedizin, Klinikum am Steinenberg, Steinenbergstr. 31, 72764 Reutlingen, Germany
Reutlingen, , Germany
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock
Rostock, , Germany
Countries
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References
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Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.
Baillard C, Bourdiau S, Le Toumelin P, Ait Kaci F, Riou B, Cupa M, Samama CM. Assessing residual neuromuscular blockade using acceleromyography can be deceptive in postoperative awake patients. Anesth Analg. 2004 Mar;98(3):854-7, table of contents. doi: 10.1213/01.ane.0000100150.84698.8c.
Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
Kotake Y, Ochiai R, Suzuki T, Ogawa S, Takagi S, Ozaki M, Nakatsuka I, Takeda J. Reversal with sugammadex in the absence of monitoring did not preclude residual neuromuscular block. Anesth Analg. 2013 Aug;117(2):345-51. doi: 10.1213/ANE.0b013e3182999672. Epub 2013 Jun 11.
Unterbuchner C, Blobner M, Puhringer F, Janda M, Bischoff S, Bein B, Schmidt A, Ulm K, Pithamitsis V, Fink H. Development of an algorithm using clinical tests to avoid post-operative residual neuromuscular block. BMC Anesthesiol. 2017 Aug 4;17(1):101. doi: 10.1186/s12871-017-0393-4.
Other Identifiers
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N° 1783/ 07
Identifier Type: -
Identifier Source: org_study_id
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