Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

Development of an Algorithm Using Clinical Tests to Avoid Post-operative Residual Neuromuscular Block

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

Study Overview

• Status: Completed
• Conditions: Postoperative Residual Curarization
• Intervention / Treatment: Device: Acceleromyography

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.

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • 6Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,
  • Mainz, Germany, 55131
    • Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Münster, Germany, 48149
    • Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster
  • Reutlingen, Germany, 72764
    • Klinik für Anaesthesiologie und operative Intensivmedizin, Klinikum am Steinenberg, Steinenbergstr. 31, 72764 Reutlingen, Germany
  • Rostock, Germany, 18057
    • Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Electromyography; Neuromuscular function was monitored, using evoked electromyography of the adductor pollicis muscle with a neuromuscular transmission module by a non-blinded investigator.
EXPERIMENTAL: Acceleromyography; Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.	Device: Acceleromyography; Use of an uncalibrated acceleromyography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical muscle function tests	Measurement of postoperative residual curarisation with clinical muscle function test: time able to open the eyes; appearence of diplopic images; time able to stick out the tongue; spatula pressure test; time able to lift the head; time able to lift the arm; strength of the patient pressing the investigator's hand; ability to swallow 20 ml of water	Muscle function tests are performed immediately after extubation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncalibrated acceleromyography	Contralateral to the electromyography arm an uncalibrated acceleremyography measures objectively postoperative residual curarisation by examination of the train of four ratio.	Uncalibrated acceleromyography is measured immediately after extubation.
Qualitative neuromuscular measurement	Contralateral to the electromyography arm qualitative tactile judgement of the train of four stimulation was measured by acceleremyography to scale postoperative residual curarisation.	Qualitative acceleromyography is measured immediately after extubation.

Collaborators and Investigators

• Sponsor: University of Regensburg
• Collaborators: University Hospital Muenster; Technical University of Munich; University Hospital Schleswig-Holstein; Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2008
• Primary Completion (ACTUAL): July 25, 2009
• Study Completion (ACTUAL): July 25, 2009

Study Registration Dates

• First Submitted: July 8, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: muscle function tests
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: N° 1783/ 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No