Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

• Sponsor: University of Regensburg (Other)
• Overall Status: Completed
• CT.gov ID: NCT03219138
• Collaborator: Technische Universität München (Other), University Hospital Muenster (Other), University Hospital Schleswig-Holstein (Other), Johannes Gutenberg University Mainz (Other)
• Enrollment: 265
• Locations: 5
• Arms: 2
• Actual Duration (Months): 18.5
• Patients Per Site: 53
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Residual Curarization	Device: Acceleromyography	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 265 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• 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.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.
• Masking: Single (Care Provider)
• Masking Description: Immediately after extubation the blinded anaesthesiologist (care provider), who performs anesthesia, tests the patient in the operating room. The blinded anaesthesiologist is unable to see the data on the EMG monitor and the movement of the adductor pollicis muscle.
• Primary Purpose: Diagnostic
• Official Title: Development of an Algorithm Using Clinical Tests to Avoid Post-operative Residual Neuromuscular Block
• Actual Study Start Date: Jan 8, 2008
• Actual Primary Completion Date: Jul 25, 2009
• Actual Study Completion Date: Jul 25, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical muscle function tests [Muscle function tests are performed immediately after extubation.]

   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

Secondary Outcome Measures

1. Uncalibrated acceleromyography [Uncalibrated acceleromyography is measured immediately after extubation.]

   Contralateral to the electromyography arm an uncalibrated acceleremyography measures objectively postoperative residual curarisation by examination of the train of four ratio.

2. Qualitative neuromuscular measurement [Qualitative acceleromyography is measured immediately after extubation.]

   Contralateral to the electromyography arm qualitative tactile judgement of the train of four stimulation was measured by acceleremyography to scale postoperative residual curarisation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	6Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,	Kiel		Germany	24105
2	Klinik für Anaesthesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz		Germany	55131
3	Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Münster	Münster		Germany	48149
4	Klinik für Anaesthesiologie und operative Intensivmedizin, Klinikum am Steinenberg, Steinenbergstr. 31, 72764 Reutlingen, Germany	Reutlingen		Germany	72764
5	Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universität Rostock	Rostock		Germany	18057

Sponsors and Collaborators

• University of Regensburg
• Technische Universität München
• University Hospital Muenster
• University Hospital Schleswig-Holstein
• Johannes Gutenberg University Mainz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Epub 2005 Sep 23.
• 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.
• 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.

• Responsible Party: Christoph Unterbuchner, Principal Investigator, University of Regensburg
• ClinicalTrials.gov Identifier: NCT03219138
• Other Study ID Numbers: N° 1783/ 07
• First Posted: Jul 17, 2017
• Last Update Posted: Jul 17, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christoph Unterbuchner, Principal Investigator, University of Regensburg: muscle function tests
• Additional relevant MeSH terms: Delayed Emergence from Anesthesia

Study Results

No Results Posted as of Jul 17, 2017