Clinical trial NCT03219138: Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.
Official title: Development of an Algorithm Using Clinical Tests to Avoid Post-operative Residual Neuromuscular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Residual Curarization
Keywords: muscle function tests
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: University Hospital Muenster
name: University Hospital Schleswig-Holstein
name: Johannes Gutenberg University Mainz
First posted: 2017-07-17
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: During anaesthesia calibrated neuromuscular function is monitored using evoked EMG of the adductor pollicis muscle (immobilised forearm) with a NMT module by a non-blinded investigator. During surgery, the (blinded) attending anaesthesiologist administers maintenance doses of atracurium according to clinical needs, i.e. without knowing the TOFR.

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.
Primary purpose: DIAGNOSTIC

Brief summary: Objective neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function tests to identify PORC

Detailed description: Background: Quantitative neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologists, however, use insensitive, qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this multicentre, prospective, double-blinded, assessor controlled study is to develop an algorithm of muscle function tests to identify PORC.

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.

Eligibility criteria: Inclusion Criteria: The patients were scheduled for elective low risk surgical procedures:

* laparoscopic abdominal procedures
* orthopedic
* minor visceral surgery

Exclusion Criteria:

* participation in another study
* body mass index over 30
* history of neuromuscular diseases
* gastro-esophageal reflux disease.

Primary outcomes:
measure: Clinical muscle function tests
timeFrame: Muscle function tests are performed immediately after extubation.
Secondary outcomes:
measure: Uncalibrated acceleromyography
timeFrame: Uncalibrated acceleromyography is measured immediately after extubation.
measure: Qualitative neuromuscular measurement
timeFrame: Qualitative acceleromyography is measured immediately after extubation.
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: 6Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,
city: Mainz
country: Germany
facility: Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Münster
country: Germany
facility: Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster
city: Reutlingen
country: Germany
facility: Klinik für Anaesthesiologie und operative Intensivmedizin, Klinikum am Steinenberg, Steinenbergstr. 31, 72764 Reutlingen, Germany
city: Rostock
country: Germany
facility: Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.